Reference Manual for Doctors on
Family Planning
September 2013
This material has been funded by UK aid from the UK Government, however the views expressed do not necessarily reflect the UK Government's official policies. This document has been prepared by Project Ujjwal. Project Ujjwal is funded by the UK aid from the UK Government under Contract No. 5926, Improved Family Planning and Reproductive Health Services in India, beginning January 1, 2013. The project is implemented by a consortium led by Futures Group International in partnership with Public Health Foundation of India (PHFI), Hindustan Latex Family Planning Promotion Trust (HLFPPT), Johns Hopkins University Center for Communications Program and Oxford Policy Management (OPM). For further information, contact: Futures Group International DLF Building No. 10 B, 5th Floor, DLF Cyber City, Phase II, Gurgaon-122 002, Haryana Tel: +91-124-4702021
Reference Manual for Doctors on Family Planning and Reproductive Health
Reference Manual for Doctors on Family Planning Disclaimer Although every effort has been made to provide correct and latest information but considering the change due to scientific update, readers to requested to check before applying or practicing it.
© Project Ujjwal, 2013 All rights reserved. However, the module can be reviewed, abstracted and reproduced, acknowledging the ‘Project Ujjwal’ but are not for sale or commercial purposes.
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Foreword The Federation of Obstetric & Gynaecological Societies of India
Model Residency CHS, 605, Bapurao Jagtap Marg, Jacob Circle, Mahalakshmi (E), Mumbai-400011, INDIA Tel: +91-22-2302 1648, 2302 1654, 2302 1343 / 32954564 Fax: +91-22-23021383 email: fogsi2007@gmail.com Web: www.fogsi.org
President : Dr. Hema Divakar
Tel: (022) 2302 1648, 2302 1654, 2302 1343, Fax (022) 2302 1383 Mobile: 09900154448 /09845819191 Email: drhemadivakar@gmail.com, presidentfogsi@gmail.com
Dr. Nozer Sheriar
Secretary General Tel: 022-23620862, 26008740 Mobile: 09821097536 email: nsheriar@gmail.com
It gives me pleasure to note that Project Ujjwal has to published the Reference Manual for Doctors on Family Planning and Reproductive Health for the private sector doctors under the project on “Reproductive Health Framework” with technical support from Federation of Obstetrics and Gynecological Societies of India (FOGSI). It is expected that during capacity building exercise of private doctors, the key issues will be discussed to improve their knowledge and help them to approach client’s management in most scientific way. Although there are plenty of documents available on different methods of contraception both in Government and private sectors, these documents are special and different , and are targeted to up gradation of insightful and practical knowledge of social franchisee doctors who are otherwise a busy practitioners. FOGSI always committed to support both public and private sectors through continuous knowledge sharing in diverse field of maternal health though different approach like CMEs, Distance learning, networking with different partners like PHFI, Jhepigo etc. In 2013 FOGSI conducted series of CMEs, across the country and support number of initiatives. Our Vision 2022 initiatives under the banner of the ABCDE projects hope to see building of a healthy generation next, with awareness and empowerment with knowledge of reproductive rights and choices. Population stabilization, modern contraceptives prevalence, saving the girl child are some of the major thematic areas where FOGSI is currently engaging their activities.
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Reference Manual for Doctors on Family Planning and Reproductive Health
When PHFI approached FOGSI to become their knowledge partner to develop the technical materials especially for franchisee doctors, FOGSI immediately accepted the proposal. I am thankful to Dr Saumendra Bagchi and other colleagues of PHFI to give us opportunity to collaborate for this project. On 18th June, 2013 the eight members of FOGSI colleague across the country was present in National Expert meet at Delhi to finalize the modules, with FAQs and practicle problems addressed. Beside finalization of the manual, the FOGSI commits its support for the project as State Trainers in Bihar and Odisha, organizing CMEs, Supporting E learning platform, developing Centre of Excellence in Family Planning etc. The support from FOGSI Colleagues need special appreciation and FOGSI appreciates the spirit of HOPE and BRIGHT FUTURE in the name of the project “Ujjwal” which symbolizes optimism . On behalf of FOGSI , I am also thankful to other partners of the Project Ujjwal for their active support in different thematic areas for the project. “Investment in Knowledge pays the best interest” —Benjamin Franklin I am thankful to UK AID for supporting the project in Bihar and Odisha.
Best wishes
Dr. Hema Divakar President, FOGSI
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Foreword
It gives me immense pleasure to note that The Public Health Foundation of India (PHFI) has prepared a reference manual for doctors and their staff for the project “Improving Family Planning and Reproductive Health Services in India�. The project will be implemented in the states of Bihar and Odisha. PHFI, as a consortium project partner with Future Groups and other organizations, is responsible for capacity building initiatives of franchisee doctors. This initiative recognises the need for bridging capacity gaps that exist in the provision of family planning services. The inclusion of private providers in service provision, counselling and capacity building is intended to supplement and leverage the government resources for achieving optimal results. Provision of family planning services is one of the key strategies to reduce maternal morbidity and mortality from unwanted pregnancies improves birth spacing and prevents unsafe abortion. Government of India accords family planning services high priority and encourages States to provide quality services to poor, low parity couple and youth. Recently the Government of India launched the Reproductive, Maternal, Neonatal and Child Health programme (RMNCH), where Family planning services have been given priority. In the states of Bihar and Odisha, there is high unmet need for family planning services with regard to both spacing and limiting methods. The critical gap in quality family planning services needs to be addressed through planned and purposeful engagement of nongovernmental service providers. The project will address the involvement of private sector in social franchisee mode. As a partner on this important effort, we look forward to focusing on the theme of building technical capacity of private service providers in the area of family planning and reproductive health. Efforts will also focus on educating service providers on comprehensive abortion care, the PC&PNDT Act and postpartum family planning.
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Reference Manual for Doctors on Family Planning and Reproductive Health
The capacity building strategy envisaged for the project will create a pool of skilled private providers, in Odisha and Bihar, to provide efficient services and adherence to the standard guidelines. The project will also facilitate collaborations with professional associations like the Federation of Obstetric and Gynaecological Societies of India (FOGSI). I am thankful to FOGSI for providing technical support for developing the training materials. My special appreciation is to leading family planning experts from different professional organizations and other individuals who made significant contribution to finalize the modules. We are thankful to Futures Group for inviting the Public Health Foundation of India to be a technical partner in this project. We look forward to their continued support in the capacity building activities. I would also like to thank the UK Aid for their support for this project. I wish all the organisations and individuals engaged in this project success, measured through both process and outcome indicators.
Prof. K. Srinath Reddy President, Public Health Foundation of India
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Preface
The National Rural Health Mission has intensified delivery of evidence based interventions to achieve health related Millennium Development Goals. There is increasing recognition of engaging with vast private service delivery sector and leverage their potential in addressing unmet needs especially in matters of reproductive health including family planning. “The Improved Family Planning and Reproductive Health Services in India� Project was awarded by UK aid to a consortium partnership to Futures Group (lead partner) with Public Health Foundation of India (PHFI), HLFPPT, John Hopkins Bloomberg Centre for communication Programme (JHUCCP) and Oxford Policy management Asia (OPM). Intervention has been planned to catalyze the private sector to scale-up choice of good quality, affordable FP and reproductive health (RH) services for poor women in Bihar and Odisha The present document is developed with the intention of fulfilling knowledge gaps amongst private providers about recent developments in contraceptive technologies and other Reproductive health interventions. The Pharmaceutical sector which reaches out to private sector for detailing drugs also ignores sharing knowledge on newer contraceptives. In the past, such documents have been developed and Government of India has also been proactively updating the guidelines from time to time. Being a consortium partners for the Project, Public Health Foundation of India has been given specific responsibility for building capacity of the franchisee doctors in Bihar and Odisha. To do so, PHFI initiated preparing technical guidelines on Family Planning and Safe Abortion for private doctors. Development of such a technical document is a complex process. One need to keep in mind information needs of the target group as well as available evidence and best practices globally while at the same time does not deviate from Government guidelines. There has to be vetting by the Reproductive Health Professionals as well as programme managers and development partners. . Several in house discussions and meetings with experts helped in finalizing the design of the proposed trainings and what should go in to reference manual, which can be referred by doctors in their regular practice. As the private doctors under social franchisee network are supposed to be busy general practitioners in the rural belt of Bihar and Odisha, they may have very specific questions, myths and misconceptions on different contraceptive methods and safe abortion. Hence this document stresses on frequently asked questions in each section. An attempt has been made to keep the language simple and ensure that document is reader vi
Reference Manual for Doctors on Family Planning and Reproductive Health
friendly. Issues related to gender, rights, quality and equity are adequately emphasized at appropriate places. The document which you have in your hand is result of team work, steered by PHFI. FOGSI is keenly engaged at the different steps in the development of this module and provided useful suggestions on earlier drafts. FOGSI will be playing a critical role in capacity building of franchisee doctors through national and state FOGSI members. We are thankful to Dr Hema Diwakar, President FOGSI and her team of experts and we sincerely acknowledge the great contribution of FOGSI and will continue our partnership in future. Similarly we get tremendous support from consortium partners, Shuvi Sharma (Team leader for RH Framework Project), Dr. Nidhi Chaudhuri and Lalitha Iyer from Futures Group, Dr. PC Das and Dr. Minal Singh from HLFPPT , for their support and guidance and in preparation of the module. We express our sincere thanks to experts like Dr Alok Banerjee- Technical Advisor Parivar Seva Sansthan, Dr BP Singh, President Enable Health Society, Dr Swasati Das-Senior Advisor Jhpiego for their critical feedback. Professor K. Srinath Reddy, President, PHFI is the guiding force for us and he always encourage colleagues for significant contribution in the field of public health through quality capacity building activities. “Knowledge to action” is the PHFI vision and we undertake these initiatives to fulfill the PHFI vision. We are extremely thankful to Professor Srinath Reddy for his constant encouragement and guidance. Dr. Dinesh Agarwal, Senior Consultant for this project with PHFI, organized different chapters and ensured that information is consistent with national guidelines as well as evidence based. Finally, without the support of PHFI colleague, it would have been impossible to prepare the module. My colleague Dr. Dinesh Jagtap and Ms. Nirmala Mishra – Senior Programme Manager, Surabhi Sharma- Junior Consultant, PHFI, actually work beyond human capacity to make the module technically correct and incorporate so many suggestions from different experts. It was a great team effort within PHFI to finalize the technical content. We sincerely hope that, this document would fill the void in this area especially for private providers and empower them to address unmet RH needs through provision of client sensitive, need based and quality oriented services.
Dr. S. N. Bagchi National Capacity Building & Quality Assurence Expert RH Frame Work Project
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Abbreviations and Acronyms AIDS Acquired Immuno Deficiency Syndrome ANM
Auxillary Nurse Midwife
ART Antiretroviral Therapy BP
Blood Pressure
BBT
Basal Body Temperature
BMD
Bone Mineral Density
CC
Cubic Centimetres
CEDAW
Convention on Elimination of All Forms of Discrimination Against Women
CES
Coverage Evaluation Survey
CICs
Combined Injectables Contraceptive
COC
Combined Oral Contraceptive
CPA
Cyproterone Acetate
CuT-220C
Copper Bearing IUDs
CVS
Cardiovascular System
DGO
Diploma in Obstetrics and Gynaecology
DHT
Di-Hydro Testosterone
DMPA
Depot-Medroxyprogesterone Acetate
DVT/PE
Deep Vein Thrombosis/ Pulmonary Embolism
ECP
Emergency contraceptive Pill
EE
Ethyle Estrodione
FAB
Fertility Awareness based Methods
FAM Fertility Awareness Methods FAQs
Frequently Asked Questions
FC1
Female Condom 1
FC2
Female Condom 2
FOGSI
Federation of Obstetrics and Gynaecological societies of India
FP
Family Planning
FSH Follicle Stimulating Hormone
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Reference Manual for Doctors on Family Planning and Reproductive Health
GCC
Genetic Counselling Centre
GL
Genetic Lab
GOI Government of India HBV
Hepatitis B Virus
HCG
Human Chorionic Gonadotropin
HCV
Hepatitis C Virus
HES
Heta Starch
HIV
Human Immuno Deficiency Virus
HLD
High Level Disinfectants
HPV
Human Papilloma Virus
HVB
Hepatitis B
ICMR
Indian Council of Medical Research
ICPD
International Conference on Population and Development
IMA Indian Medical Association IPPF
International Planned Parenthood Federation
IUCD
Intrauterine Contraceptive Devices
IUD
Intrauterine Devices
IV
Intra venous
JSK
Jansankhya Sthirata Kosh
LAM
Lactational Amenorrhea Method
LH
Leutenising Hormone
LMP
Last Menstrual Period
MLCu- 375
Copper bearing IUDs
MoHFW
Ministry of Health and Family Welfare
MOU
Memorandum of Understanding
MPA
Medroxyprogesterone Acetate
MTP
Medical Termination of Pregnancy
NET-EN
Norethisterone Enanthate
NFHS-3
National Family Health Survey
NGO
Non Governmental Organization
NRHM
National Rural Health Mission ix
NSAIDS
Non-steroidal anti-inflammatory drugs
NSSO
National Sample Survey Organization
NSV
Non Scalpel Vasectomy
OC
Oral Contraceptive
OPD Outpatients Department OT
Operation Theatre
PC-PNDT
Pre-Conception and Pre- Natal Diagnostic Techniques
PGD
Pre- Implantation Genetic Diagnosis
PID
Pelvic Inflammatory Diseases
PLHIV
People Living with HIV
POPs
Progesterone- Only Pills
QAC
Quality Assurance Council
Rh
Rhesus Blood Group
RSS
Research Studies & Standards
SDM Standard Day Method SOP
Standard Operating Procedures
SRB
Sex Ratio at Birth
STD Sexually Transmitted Disease STI
Sexually Transmitted Infections
Tcu-380A
Copper bearing IUDs
UN
United Nations Population Fund
UNFPA
United Nations Population Fund
USG Ultrasonography VTE
Venous Thrombosis
WHO
World Health Organization
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Reference Manual for Doctors on Family Planning and Reproductive Health
National Experts Dr. Hema Divakar, President FOGSI, completed her graduation and post-graduation from Mumbai & now a leading Obstetrician & Gynecologist in Bengaluru, Karnataka. She has a keen interest in High Risk Pregnancy Care. She as Technical Expert contributed in numerous activities and documents of MoHFW, GoI. In FOGSI she is a National Technical expert for EmOc Programme and also part of several other task groups.
Dr. Indrani Ganguli Emeritus Consultant Professor GRIPMER. She is Head of Department & Chairperson, Institute of Obstetrics & Gynaecology, Sir Ganga Ram Hospital, New Delhi. Dr. Ganguli is Vice President Elect 2014 FOGSI and President Elect All India NARCHI 2014-16. Colposcopy, Oncology, Endoscopic Surgery, Geriatric Medicine and high-Risk Pregnancies are of special interest to her.
Dr. Jayam Kannan is a practicing Obstetrician & Gynecologist with more than 25 years of experience with government and private health care set ups. She is a merit scholarship holder throughout her study and awarded gold medal in her medical graduation and post-graduation. She has long list of awards and is a recipient of President award also. Besides this received Life time achievement award by IMA in 2009. Presently she is Chairperson Adolescent Health Committee FOGSI. Dr. Atul Ganatra is a practicing Obstetrician Gynecologist and Gynecological Endoscopist. Presently he is Chairperson MTP Committee FOGSI and past VicePresident, Indian Medical Association. He is a Coordinator for Department of Gynec Endoscopy Fortis Hospitals, Mumbai and Consultant at Fertility & IVF Clinic Jupiter Hospital Thane, Hira Mongi Navneet Hospital, Mumbai and Guru Nanak Hospital & Research Centre Mumbai Dr. Shobha. N. Gudi is a Professor and head of the department of Obstetrics and Gynaecology at St. Philomina’s Hospital, Bangalore. She is in teaching and clinical practice for more than 20 years. She is Consultant at Excel Care hospital, Bangalore and Manipal group of Hospitals, Bangalore. She has list of publications in FOGSI Journals. Dr. Gudi has presented several papers at National, Regional and International conferences. Dr. Chandravati is a Prof. Emeritus -Department of Obstetrics & Gynaecology, K.G. Medical College and a leading practitioners. She has published more than 50 papers in national journals and more than 15 papers in international journals. Read over 40 papers, given many keynote address and orations. Dr. Chandravati guided nearly 150 thesis. She is recipient of various awards from Central and State Government for family planning work. xi
Dr. Basab Mukherjee is a Consultant Gynaecologist & Laparoscopic Surgeon. He completed his medical degree and post degree from CMC Vellore. He authored 20 chapters & edited numerous books. Dr. Basab has been faculty for 200 plus workshops and conferences being held at local, National and International levels.
Dr. Parag Biniwale is a practicing Gynaecologists & a Post graduate teacher for DNB, Pune. He is a National Website Editor, FOGSI (2011-2013). He also holds the position of chairman, Young Talent Promotion Committee, FOGSI 2008-2010. Dr. Biniwale as master trainer for Adolescent Friendly Health Services conducted many workshops for FOGSI, WHO, UNFPA and GoI. He is an editor of book “A Gynaecological manual of adolescent girls & young women and contributed chapters to FOGSI publications. Dr. B. P. Singh completed his medical graduation and post- graduation from Uttar Pradesh. Having over 40 years of experience he worked as clinician and hospital administrator in Department of Health and Family Welfare, Uttar Pradesh. For more than 13 years was associated with Engender Health in different capacity. Currently Dr. B. P. Singh is president of Enable Health Society, an Indian National NGO. Dr. B. P. Singh is also member of expert group to develop GoI Family Planning Guidelines. Dr. Alok Banerjee an eminent medical person having more than 35 years experiences in the field of Reproductive Health particularly on family planning, abortion, infertility, adolescents sexuality etc. Graduated in Medicine from Calcutta Medical College followed by post-graduation from AIIMS, New Delhi, he worked at several organizations namely AIIMS, National Institute of Health & Family Welfare (NIHFW), USAID etc. He was first in the country to bring NSV procedure. He has several publications in both national & international journals. Dr. Banerjee serving as member in various committees of Govt. of India. Dr. P. C. Das is a medical graduate with more than 42 years of professional experience. He retired as Deputy Commissioner, MOHFW and provided leadership in RCH II, NRHM. Authored Protocols and Manuals in the Ministry, developed curriculum in Health Education for SEARC countries. He was member secretary for Health Education & IEC for tenth Five Year Plan. Presently, with HLFPPT for capacity building, quality assurance and medical audit of both public and private hospitals of the country and ICMR clinical monitor for the Biomedical Research. Also examiner at IGNOU. Dr. Dinesh Agarwal is a public health expert. He completed his medical education from Jaipur, Rajasthan. Served as a faculty starting from junior lecturer to associate professor at RNT Medical College Udaipur, Rajasthan. He was associated with UNFPA for more than 15 years and retired as National Programme Officer (Reproductive Health and HIV/AIDS), UNFPA. He has several publications on Family Planning. xii
Contents Page No. Chapter 1: Fertility scenario, Unmet Need and Reproductive Rights
1
Chapter 2: Quality of Care in Family Planning, Counselling and role of private sector
9
Chapter 3: Reversible Contraceptives
17
Chapter 4: Irreversible Methods
85
Chapter 5: Natural Family Planning Methods
105
Chapter 6: Termination of Pregnancy
115
Chapter 7: PC - PNDT Act: Salient Features, Compliance and Protecting access to Safe Abortion
131
Chapter 8: Accreditation of Private Providers for Family Planning Services
141
Annexures
147
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Chapter 1
Fertility Scenario, Unmet Need and Reproductive Rights
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Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights
Introduction Voluntary family planning is widely adopted throughout the world. More than half the couples in developing countries now use a modern contraceptive method for timing, spacing or limiting birth of children to achieve their reproductive intentions. In fact, few public health measures have demonstrated such a vast impact on health, saving lives and promoting a healthier population, at very low cost. A recent report in the medical journal Lancet, presents the most complete countryspecific information about trends between 1990 and 2010, with projections to 2015, in two key family planning indicators for married or cohabiting women - the use of any contraceptive method (contraceptive prevalence), and the non-use among women who want to avoid childbearing for at least two years (unmet need). Worldwide, in the last two decades, contraceptive prevalence increased from 55 percent to 63 percent, and unmet need decreased from 15 percent to 12 percent, but glaring disparities between countries still remain. The success is not consistent across countries or even within countries. It is estimated that in the developing world some 222 million women would like to space or limit their children but are not using a contraceptive method for a variety of reasons. This estimate supports the call, at the 2012 London Summit on Family Planning, for a focused effort to bring contraception to people in countries where its use is still confined to a minority. It is estimated that demand for family planning will go up by 40 percent as a record number of young people enter child bearing age. These two indicators (contraceptive prevalence and unmet need) respond to different agendas but are complementary. Contraceptive prevalence is the main determinant of fertility; typically, an increase of 15–17 percentage points in prevalence reduces fertility (and thus population growth) by one birth per woman. The total fertility rate at world level is expected to go down from 2.82 in 1995-2000 to 2.15 by middle of this century. In the past 50 years, most governments in developing countries have enacted policies to reduce population growth through promotion of family planning as an integral component of development. However, in contrast to demographic targets for death reduction, targets for birth reduction have proved controversial because of concerns that couples might be pressured or even coerced into use of contraception. By responding to the human rights agenda of reproductive choice, unmet need avoids these concerns. Unmet need has become a central rationale for donor support and advocacy and a crucial guide for interventions, culminating in its addition, in 2007 as one of the indicators to monitor progress in target 5b of the Millennium Development Goals to “achieve, by 2015, universal access to reproductive health�.
Countries with high fertility rates also record high unmet need There is good news on the population front in India as the sharpest decline in population growth rate was registered in the 2011 census. More recently the Sample Registration Survey(by the Registrar General of India) has estimated total fertility rate (TFR) as 2.4 (SRS 2011) and it is expected that replacement level fertility of 2.1 will be achieved by 2017. Clearly, going forward, it will be important for the family planning programme not only to address unmet contraceptive needs but also focus on addressing regional/ social and income inequalities in access to contraception.
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Reference Manual for Doctors on Family Planning and Reproductive Health
What are India’s population prospects in near future? A technical group constituted by the National Population Commission has made some projections. It is assumed that TFR would reach replacement level by 2017. However, different agencies don’t have a consensus on the dates. Much would also depend on how changes in age at marriage and contraceptive use are taking place. Given that India has biggest ever cohort of young people, population momentum would continue to contribute nearly 75 percent to total fertility. Additionally, as the recent ‘Global Report Card on Adolescents 2012’ states, adolescent girls in developing countries like India are more likely to have sex before they turn 15, as compared to boys their age. The report also reveals that while three percent boys, in the 15-19 year age category, had sex before reaching 15, almost eight percent girls in the same age group had become sexually intimate. Although the fertility rate is declining, a large youth base entering reproductive age is expected to lead to a substantive increase in population. Clearly the solution lies in providing contraceptive options to this young population that are ideal for this age group. Changing age structure also has implications as how the family planning programme needs to respond to the rising population of adolescents and young people. Although mean age at marriage is going up, couples would need services to delay the first conception, and subsequently space pregnancies. Obviously then, the programme would require a renewed focus on expanding spacing contraceptive choices in a big way. In India, only 41.2 percent of second and high order births had a birth interval of more than 36 months.
Unmet Need Women with unmet need are those who are fecund and sexually active but are not using any method of contraception, and report not wanting any more children or wanting to delay the birth of their next child. In India, an estimated 26 million women who want to delay or avoid pregnancy cannot exercise this basic right because they lack access to modern contraceptive services. These couples may also cite side effects of contraceptives, infrequent sex, fear of partner disapproval and religious beliefs as reasons for not using contraceptives. Moreover, this results in thousands grappling with unintended pregnancies and unsafe abortions. Over 60,000 women die due to pregnancy and childbirth complications every year in the country. With access to quality reproductive health services and supplies still remaining a privilege for many, the poorest and most vulnerable women are often left on the fringes of accessibility. Access to quality family planning services may be compromised for many reasons. In remote and inaccessible areas, infrastructure for service delivery may be weak or contraceptive supplies could be lacking at times. In certain cases, skilled providers are not available. In rural areas, especially where health services are at a distance, conditional cash transfer schemes have helped to draw many more women and their families for safe deliveries at institutions. Increasing footfalls to health centres would be more beneficial if there is access to counseling in order to help women make informed choices on the method of contraception during the postpartum (after delivery) period. Dispelling myths and misconceptions about family planning methods would encourage individuals and couples to opt for appropriate choices. India has a unique interface between the public health system and the
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Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights
community, with every village having Accredited Social Health Activists, popularly known as ASHAs who are trained to provide information on available contraceptive methods. Alongside, prospects for scaling up social marketing and social franchising of existing programmes must be explored. In addition, non-state actors should be brought into the fold through publicprivate-partnerships and increased corporate social responsibility. For countries like India, universal access to quality family planning is a critical component for development and the expected returns far outweigh the costs incurred. Providing contraceptive information and services as part of sexual and reproductive health would lower maternal deaths by a third. Research reveals that when a woman has access to voluntary family planning, she tends to have fewer and healthier children and invests more in their health and education, and helps break the vicious cycle of poverty.
Contraceptive Use International Conference on Population and Development (ICPD), (1994) recognized that appropriate methods for couples and individuals vary according to their age, parity, family size preference and other factors, and thus the programme should ensure that both women and men have access to information and effective family planning methods in order to exercise free and informed choice. Current Use of Family Planning Methods in India Male Sterlization 1%
Pill 4% IUD 2%
Condom 6% Any Traditional Method 7%
Female Sterlization 34% Non user 46%
(Source: DLHS-3 2007-08)
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Reference Manual for Doctors on Family Planning and Reproductive Health
India’s programme is largely dominated by female sterilization. Mean age of sterilization among women is around 25 years. Choices for spacing methods are very few. No new spacing method has been included in the programme for the last 10 years, although injectables/vaginal rings are available in the private sector. Often newly married couples wish to delay pregnancy and subsequently opt for spacing between births. It is more than obvious that young couples are not ideal candidates for sterilization services because of its irreversible nature. With patriarchy being entrenched in the social fabric of the country, male participation by accepting responsibility for contraception is abysmally low. Only one percent males in India opt for sterilization as opposed to 37.3 percent females. In light of the fact that female sterilization continues to be a predominant method of contraception in India, it is important to promote the use of reversible methods such as oral pills, condoms and intrauterine devices (IUDs). Additionally there is also a need to expand on the available contraceptive choices. For instance, in Bangladesh, a major decline in fertility levels have been achieved by largely promoting spacing methods and expanding the basket of contraceptive choices by including hormonal contraceptives such as injectables and implants. Substantial evidence indicates that a restricted choice of contraceptive methods has constrained couples from using the method that best suits their needs, resulting in a lower level of contraceptive prevalence and high unmet need. Freedom to choose from range of methods according to ones need and preferences rests on the availability of methods.
Family Planning within Reproductive Rights Framework Access to quality family planning is a non-negotiable human right. Governments that have ratified international human rights agreements, have an obligation to honour their commitments in this regard. In the Programme of Action endorsed by almost 180 countries at the International Conference on Population and Development in 1994 at Cairo, Governments resolved: “The principle of informed free choice is essential to the long-term success of family-planning programmes. Any form of coercion has no part to play”. In every society there are many social and economic incentives and disincentives that affect individual decisions about child-bearing and family size. Governmental goals for family planning should be defined in terms of unmet needs for information and services and method specific targets should not be imposed...”
Gender Issues in Family Planning Gender refers to those characteristics of men and women that are socially and culturally determined. These characteristics differ in different places and in every society they change over time. Gender is relational and is often unequal and hierarchical. The gender barriers in use of family planning services need to be addressed. Many women do not have the autonomy to decide on the number of children they have, and when. They also do not have any say in sexual relations and find it difficult to negotiate the use of contraceptives. Programmes 5
Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights
have perpetuated gendered stereotypes by promoting female sterilization and it is women who are expected to shoulder the maximum burden of contraception. Lack of access to money also acts as a barrier for accepting family planning methods. A provider’s judgmental attitude also places huge barriers to access to contraceptive services. High unwanted need for contraception indicates that many women either wish to space or do not want to have more children, but are unable to use any family planning method. Women are less likely to be informed about contraceptive methods and their sources of availability; they may fear spousal or some other family member’s resistance to the contraceptive use. Additionally service providers may not offer a full range of quality services such as IUD insertions under aseptic conditions which may also create problems. Follow up protocols may not be adhered to in full and modalities for management of complications may be missing. The absence of quality services could result in high contraceptive morbidity. In the context of family planning, as providers, we must always address the vulnerability of women being burdened with unwanted pregnancies, their degree of autonomy for decision making and their resources for seeking services as well as access to quality services.
Equity in Contraceptive use Globally, many sexually active young people who want to avoid pregnancy are not using modern family planning methods for various reasons, including a lack of access to services or disapproval by health providers. A significant portion of unmet need is indicated by the high levels of abortion among young women, as reported in surveys and inferred from hospitalizations after unsafe abortions, as well as by estimates of out-of-wedlock pregnancies and young women’s reports to interviewers that their first or second births took place earlier than they desired (UNFPA, 2003).In most societies, childbearing after marriage is expected and nearly universal and most newly married young people want to begin childbearing soon after marriage. Findings from the National Family Health Survey (NFHS) 3 suggest that the fertility rate in age group of 15-19 years contributes to 17 percent of TFR. The Contraceptive Prevalence Rate amongst married adolescents is very low at 13 percent. Contraceptive use increases with the education and wealth indexes. Data across three NFHS indicate no substantial change for unplanned births. Findings suggest that young married are unable to access contraceptive options because there are strong social norms around early child bearing which discourages contraceptive use soon after marriage. There are marginalized population groups such as Sex workers and People Living with HIV (PLHIV) / Antiretroviral Therapy (ART) users who also have high unmet need for contraceptives. Several studies amongst sex workers indicate the need for effective method for dual protection. The Indian Network of Sex Workers has been actively seeking the integration of reproductive health (RH) services within the framework of targeted interventions being offered under the National AIDS Control Programme. The Table below presents results from large scale coverage evaluation survey regarding contraceptive use, both for any method and for modern methods, as per some demographic characteristics.
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Reference Manual for Doctors on Family Planning and Reproductive Health
Coverage Evaluation Survey Report 2009 (CES 2009) Background Characteristics
Any Method (%)
Any Modern Method (%)
Scheduled Castes
55.0
49.0
Scheduled Tribes
47.4
42.0
Other Backward Classes
53.3
47.5
Others
61.0
52.3
Lowest Wealth Index
40.1
34.0
Second Wealth Index
46.9
40.7
Middle Wealth Index
54.5
48.4
Fourth Wealth Index
59.2
52.8
Highest Wealth Index
64.0
56.4
India (15-49)
54.8
48.2
India (15-44)
54.0
47.1
Clearly one notices low contraceptive use in poor income quintiles and disadvantaged social groups.
Sexual and Reproductive Rights What are Reproductive Rights? Attaining the goals of sustainable, equitable development requires that individuals are able to exercise control over their sexual and reproductive lives. This includes the rights to: yy Reproductive and sexual health as a component of overall health, throughout the life cycle, for both men and women. yy Reproductive decision-making, including voluntary choice in marriage, family formation and determination of the number, timing and spacing of one’s children and the right to have access to the information and means needed to exercise voluntary choice. yy Equality and equity for men and women, to enable individuals to make free and informed choices in all spheres of life, free from discrimination based on gender. yy Sexual and reproductive security, including freedom from sexual violence and coercion, and the right to privacy.
Protecting Reproductive Rights During the 1990s a series of important United Nations conferences emphasized that the well-being of individuals and respect for their human rights should be central to all development strategies. Particular emphasis was given to reproductive rights as a cornerstone of development, and to empowerment of women as being an important element in ensuring the exercise of these rights. All major human rights treaties and consensus statements obligate countries to protect and promote rights that relate to reproductive health. Of all human rights documents, the Convention 7
Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights
on Elimination of All Forms of Discrimination Against Women (CEDAW), a treaty binding on 165 countries, provides the strongest legal support for the right to reproductive health per se. In Article 12, CEDAW guarantees non-discrimination in access to health care, including affordable services and information related to family planning, pregnancy, and the post-natal period. The statements issued after the 1994 International Conference on Population and Development (Cairo) Programme and the 1995 World Conference on Women (Beijing) are consensus statements that confirm the centrality of reproductive rights in advancing the health of populations and the status of women. Beijing, in particular, recognizes women’s right to control their own sexuality and sexual relations and to decide upon these matters on an equal basis. Similarly, the International Planned Parenthood Federation (IPPF), Charter on Sexual and Reproductive Rights is based on twelve rights that are grounded in core international human rights instruments and additional rights that IPPF believes are implied by them. The Standards section draws heavily on documents that won international consensus at four key UN conferences, which took place between 1993 and 1995, namely the UN World Conference on Human Rights (Vienna, 1993); the UN International Conference on Population and Development (Cairo, 1994); the UN World Summit for Social Development (Copenhagen, 1995); and the UN Fourth World Conference on Women (Beijing, 1995). The Charter represents IPPF’s response to the challenge of interpreting human rights language and applying it to sexual and reproductive health care issues. The classification of specific issues under certain rights represents IPPF’s judgment of where each issue should best appear; the listing of any issue under any specific right does not preclude action being taken on that issue under another right. Over the years, there has been significant progress in increasing contraceptive use in India and this is also reflected in the reduction of growth rates. However,gross inequities in use persist. Spacing methods use is abysmally low. There are serious concerns on quality of care and limited method choice. Providers need to be cognizant of these challenges in the programme and ensure that women and couples achieve their reproductive goals without any fear and coercion.
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Reference Manual for Doctors on Family Planning and Reproductive Health
Chapter 2
Quality of Care in Family Planning, Counseling and Role of Private Sector
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Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector
Overview Growing use of contraception around the world has given couples the ability to choose the number and spacing of their children and has tremendous life saving benefits. Despite this, unmet need for contraception remains high, especially amongst the poorest people and those in rural areas. Family Planning is considered a “best buy� among health investments, being one of the most cost effective and high yield interventions that exist today. Family Planning could prevent many more deaths, especially amongst the poor, if we are able to reduce unmet need. In following paragraphs is a listing of the major benefits of family planning.
Saves women’s lives Nearly one third of maternal deaths could be prevented by delaying, spacing and avoiding unwanted pregnancies and abortions to stop childbearing when the desired family size is achieved. Many pregnancies are unintended and mistimed, and the risk of death associated with such events is high. Health risks associated with close births are high in mothers below 18 years or older than 35 years. Also women with more than five children are 1.5 to 3 times more likely to die from complications during child birth. Women with more than three children are more likely to suffer from anaemia, require blood transfusion and die of bleeding than women three or less children.
Saves children lives Family planning helps women to space children thereby reducing newborn, infant and child deaths significantly. About one third of all infant deaths occur because mothers had births too close or were too young. Family planning helps women to delay pregnancy,and with spacing, more children are likely to survive during infancy and are healthier.
Saves adolescents lives Pregnancy amongst adolescents leads to health risks not only for babies but also young mothers, particularly those under 18. Family planning can help them avoid social and economic consequences of early child bearing. If girls get pregnant between the ages of 10 to 14 years they are five times more likely to die of pregnancy related causes than women aged 20 to 25 years. Many unmarried girls run the risk of pregnancy if they are sexually active. Providing contraception to them would save lives. In addition, delaying pregnancy would allow them to complete their education and prepare to join the workforce.
Reduces deaths from HIV/AIDS Consistent and correct use of condoms can reduce the rate of new cases HIV infection. Additionally, by averting unintended and high risk pregnancies, family planning reduces mother to child transmission of HIV thus reducing the number of AIDS-affected babies whose life chances are seriously diminished.
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Reference Manual for Doctors on Family Planning and Reproductive Health
Ensure environment sustainability In many places, population growth strains natural resources and leads to water shortages, deforestation, and animal extinction. Smaller families preserve essential resources which eases pressure on the environment. Climate change discourses are also including discussions on addressing unmet need as a strategy to reduce carbon footprints. Millions of couples wish to plan their families but lack access to contraception. With smaller families, parents can afford more for each child—providing better food, shelter, education, and health care. Ultimately, this raises savings, boosts productivity, and leads to economic growth.
The Health Benefits of Family Planning Family Planning has numerous health benefits for women, their sexual partners, and their children. Family planning helps to: Prevent unintended pregnancies and the number of unsafe abortions, thereby reducing: yy Maternal deaths and disabilities yy Infertility Preventing high-risk pregnancies among: yy Adolescents under age 18 yy Women over age 35 yy Women who have had many births or births spaced too closely together yy Women with HIV/AIDS and other health conditions such as malaria and tuberculosis Space births, resulting in: yy Lower rates of newborn, infant, and child mortality yy More time to breast feed, improving infant health yy More time for women to recover physically and nutritionally between births Adapted from: Susheela Singh et al., Adding it up. The Benefits of investing in Sexual and Reproductive Health Care (New York: Guttmacher Institute and UNFPA, 2003):24
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Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector
Quality of Care in Family Planning Mere provision of contraceptive services is not enough to reduce unmet needs. Contraceptive services should be of good quality. India’s family planning programme in the past was driven by method specific targets by health workers with little focus on quality of care. Quality is also a rights issue. The following element needs to be considered in organizing the quality of family planning services. Additional method choices: If a provider provides access to wide range of contraceptive methods, this would increase usage by yy Attracting new users yy Attracting past users yy Facilitating method switching yy Reducing dropout rates. Depending on many factors a client may prefer different contraceptive methods during the course of her reproductive lifespan. Hence, to address unmet need more effectively, a basket of choices should be offered. Providers skills and behaviour are critical: yy A provider should have the necessary clinical competence to offer particular methods to clients as per the national protocols and standards. yy A provider should be oriented on client-related issues which include initiation, use and satisfaction. yy A provider should not be judgmental and should allow,encourage or empower clients to make own choices. It is important to reduce dropout rates: yy These are high now. Both at programme level and individual level this has been recognized as a major challenge yy It is important to focus on reduction in dropout rates as this increases efficiency, increases contraceptive prevalence, reduces unintentional pregnancies and improves client satisfaction yy It would be useful to improve the quality of client-provider interaction during contraceptive provision so that the client can understand the specific issues relating to each method yy A provider may need to counsel clients about long acting permanent methods (IUDs, Implants, Sterilization).
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Reference Manual for Doctors on Family Planning and Reproductive Health
Improved quality of client-provider intervention can take place in the following manner: yy Help client in selecting the method appropriate to the desired reproductive intervention, i.e. delay and spacing or stopping. yy Provide information to client on potential side effects of method and how to manage these. yy Focus should be on the client rather than the methods, hence changing the method and supply source if necessary is highly encouraged. Quality contraceptive supplies are available: yy Providers should either provide these supplies or provide information about sources of quality contraceptive commodities. yy Providers should also provide information on alternate sources of supplies in case the client runs out of supplies.
Counseling in Family Planning Why counseling? A study in Egypt showed that client-centered counselling added only one minute to a consultation. Clients are three times more likely to be satisfied and continue to use the method. Key steps in family planning counselling: yy Rapport building yy Exploration yy Decision making yy Implementing the decision In rapport building, there are four critical components: yy Greet clients with respect yy Make introductions yy Assure confidentiality & privacy (visual and auditory) yy Explain need to discuss sensitive and personal issues. It is quite possible that many providers must be already doing these steps in their clinical settings. However, it would be useful to take stock of possible challenges in following these steps. Exploration: (New clients in OPD practice) yy Explore in-depth client’s reasons to visit yy Probe reproductive health related plans, current situation and past experiences with contraceptive use . 13
Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector
yy Discuss clients preferred method, if any or relevant options, provide complete information as may be required, dispel myths and misconceptions. yy Rule out pregnancy and explore factors related to menstrual bleeding, medical conditions and any recent pregnancy/abortions. Exploration: (Return clients) yy Is client satisfied with methods? Any problems with the method? yy Correct use of method. yy Ask about reproductive intentions. yy Explore reasons for dissatisfaction with accepted methods and possible options (Only for dissatisfied clients). Decision making yy Identify decisions clients need to make. yy Explore relevant options. yy Help clients weigh benefits, disadvantages and consequences of each option. yy Help client determine individual risks for sexually transmitted infections (STIs)/HIV yy Encourage client to make his or her own decision Implement decision making yy Assist client in making a concrete and specific plan for carrying out decision. yy Assist clients in developing skills to use his/her chosen method. yy Identify any barrier in implementing the plan. yy Develop strategies to overcome barriers. yy Sources of supplies. yy Make a plan for follow-up and for provider’s referrals. Tips for Successful Counselling yy Show every client respect, and help each client feel at ease. yy Encourage the client to explain needs, express concerns, ask questions. There is no need to rush during counselling. yy Let the wishes and needs of the client guide the discussion. yy Be alert to related needs such as protection from sexually transmitted infections including HIV, and support for condom use. yy Listen carefully. Listening is as important as giving correct information.
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Reference Manual for Doctors on Family Planning and Reproductive Health
yy Give just key information and instructions. Use the words the client knows. yy Respect and support the client’s informed decisions. yy Bring up side effects, if any, and take the client’s concerns seriously. yy Check that the client understands about method and its use. yy Invite the client to come back any time for any reason. Counselling has succeeded when: yy Clients feel they got the help they wanted. yy Clients know what to do and feel confident that they can do it. yy Clients feel respected and appreciated. yy Clients come back when they need to do so. yy And, most important, clients use their methods effectively and with satisfaction. Role of Private Sector In India the private sector dominates healthcare provision. Additionally, social marketing also services a large number of clients with non-clinical contraceptive methods. Considering that there is a huge network of private sector providers, there is scope to optimally engage the private sector in provision of family planning services in a systemic manner. Leveraging the vast number of private practitioners to provide family planning information, counselling and services is very much needed. The Government of India scheme for public-private partnership and the proposed universal healthcare coverage provides opportunities for enhancing this engagement.
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Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector
Demand for Family Planning is going to increase in future: yy It is estimated that the number of women in the reproductive age group (15-49 years) would increase by 10 percent by 2015 and another 8 percent by 2025, due to population momentum. yy Contraceptive needs are expected to rise as an increasing number of women want to have smaller families. yy Historically trends show that educated, urban and financially better off women have begun to want smaller families and therefore need contraceptives earlier then their less educated and poor peers. As education levels improve and media exposure increases this would further boost demand for contraception. yy Young people want to either delay or space the birth of children and hence reversible methods are preferred compared to permanent methods. Hence there would be more contacts with providers and method switching and replenishment of supplies As a private health care provider you can also add the provision of contraceptive services to the other services which you offer.
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Chapter 3
Reversible Contraceptives Barrier Methods Intrauterine Devices (IUD) Hormonal Methods Combined Vaginal Rings
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Chapter 3: Reversible Contraceptives
3.1. Barrier Methods A variety of barrier methods suitable for both males and females are available. The aim of these methods is to prevent live sperm from meeting the ovum.
3.1.1. Male Condoms Male Condom is a sheath made to fit over a man’s erect penis. Most condoms are made of latex rubber and some are coated with a lubricant or spermicide. Condoms may be available in different size, shapes, colours and textures. Male Condoms are the most widely known and used barrier device by males all around the world.
How to use 1. Man should put the condom on the erect penis before penis touches the vagina: »»
Hold the pack at its edge and open by tearing from a ribbed edge.
»»
Hold the condom so that the rolled rim is facing up, away from penis.
»»
Place the condom on the tip of penis.
»»
Unroll the condom all the way to the base of the penis. The condom should unroll easily. If it does not, it is probably backwards. If more condoms are available, throw this one away and use a new condom.
2. Most of the condoms are already lubricated; hence there is no need to apply any additional lubricant. This may damage the condom. 3. Now they can have sexual intercourse. 4. After the sexual intercourse (ejaculation), hold the rim of the condom to the base of the penis so it will not slip. The man should pull his penis out of the vagina before completely losing his erection. 5. Move away from vagina and take off the condom without spilling semen on the vaginal opening. 6. Tie a knot at the rim of the condom. A female condom should not be flushed. It can be wrapped in paper and can go as household waste. Do not leave it where children will find it. Do not use a male condom more than once.
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Reference Manual for Doctors on Family Planning and Reproductive Health
Medical Eligibility for Male Condom Use All men can safely use male condoms except those with severe allergic reaction to latex rubber.
Advantages of Using Male Condoms yy Effective in preventing pregnancy: With typical use 14 pregnancies per 100 women in the first year of use. With correct and consistent use every time, 3 pregnancies per 100 women in the first year of use. yy Male condoms can prevent sexual transmission of many diseases including HIV/AIDS, Gonorrhoea, syphilis, Chlamydia and Trichomoniasis. yy Can be used soon after childbirth. yy No hormonal side effects. yy Help prevent ectopic pregnancies. yy No delay in returning to fertility after use of condoms is stopped. yy Offer occasional contraception with no daily upkeep. yy Easy to keep at hand in case sex occurs unexpectedly. yy Can be used by men of any age. yy Can be used without seeing a healthcare provider first. yy Usually easy to obtain and sold at most places. yy Enables a man to take responsibility for preventing pregnancy and disease. yy Increased sexual enjoyment because no need to worry about pregnancy. yy Often help to prevent premature ejaculation.
Limitations yy Condoms probably protect somewhat, but not as well, against herpes, genital wart virus (HPV), and other diseases that can cause sores on skin not covered by condoms. yy Latex condoms may cause itching for a few people who are allergic to latex. Also, some people may be allergic to the lubricant on some brands of condoms. yy Couple must take the time to put the condom on the erect penis before sex. yy Small possibility that condom might slip off or break during sexual intercourse. yy If not properly stored or if used with oil based lubricants the condoms can become weak and break. yy When the female partner is using Miconazole or Econazole (for treatment of vaginal infections) damage can be caused to the latex. 19
Chapter 3: Reversible Contraceptives
Side Effects None
Managing Any Problem If the condom breaks: yy Washing both, penis and vagina with soap and water should reduce the risk of STIs and pregnancy. yy Best way would be to use emergency oral contraception to prevent pregnancy. Condom or lubricant causes itching or rash on genitals Suggest using water as lubricant. If itching continues, clients (both partners should be assessed for infection). If there is no infection and allergy to latex seems likely, help the client choose another method of contraception unless client is at risk of STIs. Man cannot maintain an erection while putting on or using a condom Discuss how to make condom use more enjoyable and less embarrassing. If the woman puts the condom on for the man, this may make use more enjoyable. Explain that, with experience, more couples are less embarrassed. Condoms are being positioned also as a sex pleasure enhancement device. Suggest a small amount of water or water based lubricant on the penis and extra lubricant on the outside. This may increase sensation and help maintain erection.
Counselling It is critical to counsel clients about condom use so that there is correct and consistent use. Use of condom by male partner also promotes male involvement in reproductive health from gender perspective as there is sharing of the contraceptive burden. Clients should be also counseled as what needs to be done in the event of slippages/ breakage and alternative sources of supply in case the regular sources run out.
Availability of Condom Male condoms are being provided through a free distribution scheme and social marketing. In addition, condoms are commercially sold by manufacturing companies under their brand names.
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Reference Manual for Doctors on Family Planning and Reproductive Health
Frequently asked questions regarding Male Condoms 1. How effective are male condoms in preventing HIV?
On an average, male condoms are 80 to 95 percent effective in preventing HIV, when used correctly with every act of sex.
2. Will using condoms reduce the risk of STI transmission during anal sex?
Yes. STIs can be passed from one person to another during anal sex act that inserts the penis into any part of another person’s body. Some sex acts are riskier than others. When using a latex condom for anal sex, a water or silicone based lubricant is essential to help keep the condom from breaking.
3. Do condoms often break or slip off during sex? What can men and women do to reduce this?
On an average, about two percent of condoms break or slip off completely during sex, primarily because they were used incorrectly. Used properly, condoms seldom break.
If a condom slips or breaks, taking emergency contraceptive pills can reduce the risk that a woman will become pregnant. However, it doesn’t protect one from STIs, including HIV.
4. Can a man put two to three condoms on at once for more protection?
There is little evidence about the benefits of using two or more condoms. It is generally not recommended because of concerns that friction between condoms could increase the chance of breakage.
5. Aren’t condoms used mainly in casual relationships or by people who have sex for money?
No. while many casual partners rely on condoms for STI protection, married couples all over the world use condoms for pregnancy protection. In Japan, 42 percent of married couples use condoms- more than any other family planning methods.
6. How to take care of male condoms? Tips for caring for condoms:
»»
Store condoms in cool, dark place, if possible. Excessive heat, light and humidity damage condoms.
»»
Use lubricated, well packed condoms. Lubrication helps prevent tears. Handle condoms carefully. Fingernail and rings can damage condoms. Do not unroll condom before use. This may weaken them. Also, an unrolled condom is difficult to put on.
Do not use the condom if:
»»
The packet is torn or damaged.
»»
It is beyond expiry date or more than five years from the date of manufacture.
»»
If it is uneven or has changed colour.
»»
If it feels brittle, dried out or very sticky.
7. Can male condoms be re-used?
No. Male condoms should not be re-used.
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Chapter 3: Reversible Contraceptives
3.1.2. Female Condoms Female condom is a condom made of a soft, thin material that fits inside a woman’s vagina. Like the male condom, the female condom is a barrier method, keeping the penis and sperm from contact with the cervix and vagina. The first generation female condom (FC1) was made from polyurethane- a thin, odourless material that is hypoallergenic, stronger than natural rubber latex, and conducts heat. The FC1 was launched in 1992 but it is no longer manufactured and has been replaced by a secondgeneration product, the FC2. The FC2 is made of nitrile rubber- a synthetic type of latex- and can be used with any type of lubricant, including oil, silicone or water based products. The newer latex based female condoms are also available commercially.
Mechanism of Action The female condom can be inserted into the vagina prior to sexual intercourse, is not dependent on the male erection and can remain in place after ejaculation. It has two flexible rings, an inner ring at the closed end, used to insert the device inside the vagina and hold it in place, and an outer ring which remains outside the vagina and covers the external genitalia. Before sex, the woman places the closed end of the female condom high in her vagina. The closed end contains a flexible, removable ring to help with insertion. A large flexible ring around the open end of the condom stays outside covering external genitalia.
Medical Eligibility for Female Condom Use Women who are allergic to latex are recommended to not use latex female condoms
Advantages of Female Condoms yy Pregnancy rate is 21 percent if it is used in a less than correct and consistent manner, but if used correctly and consistently about there is a five percent pregnancy rate. yy Female controlled. yy No medical condition appears to limit use. yy More comfortable to men, less decrease in sensation than male latex condoms. As a result, sensitivity of male partner may not be substantially reduced. It also offers ease of use by men with erectile dysfunction. yy Offer greater protection as it covers both internal and external genitalia. yy Stronger (polyurethane is 40 percent more stronger than latex) therefore less frequent breakage (1 percent compared to 4 percent for male condoms). yy Longer shelf-life even under unfavourable storage conditions.
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Reference Manual for Doctors on Family Planning and Reproductive Health
yy Sex Workers found that female condom allowed them to continue their job without interruption during menstruation.
Limitations of Female Condoms yy Not aesthetically pleasing. The coverage of the female external genitalia had a decidedly negative impact on the device’s aesthetics and acceptance. yy Difficulties in insertion and removal. Some participants noted difficulties associated with insertion and removal of the female condom during initial period, discomfort, messiness and inconvenience associated with use and movement of device during use. yy A little more expensive than male condoms although with latex condoms prices may come down further.
Counselling The user must be counseled whenever the she wants. This should be done in the following steps. Ensure that the client understands the correct use. Ask the client to explain the basic steps of using the female condom while handling one. If a model is available, the client can practice inserting the condom in the model and then taking it out. yy Ask the client how many condoms she thinks will need until she can return. Assist with information on availability of female condoms in the market. yy Explain why using a new condom with every act of sex is important. yy Explain about emergency contraceptive pills (ECP’s). Explain ECP use in case of errors in condom use- including not using a condom – to help prevent pregnancy. yy Discuss techniques and skills for negotiating condom use with partners.
Tips for New Users yy Suggest to a new user that she practice putting in and taking out the condom before she next has sex. Reassure her that correct usage becomes easier with practice. A woman may need to use the female condom several times before she is comfortable with it. yy Suggest she try different positions to see which way insertion is easiest for her. yy The female condom is slippery. Some women find insertion easier if they put it in slowly, especially the first few times. yy If the client is switching from another method to the female condom, suggest she continues with the previous method until she can use the female condom with confidence.
Reasons to Return yy Assure every user that she is welcome to come back any time she has problems, questions
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Chapter 3: Reversible Contraceptives
or wants another method; has any major change in health status or she thinks she might be pregnant. yy If she has difficulty using female condoms correctly.
Managing Any Problem Penis does not enter the female condom, but slips between the sheath and the vagina wall yy Man should withdraw penis and start over again with same female condom. yy Add lubrication. yy Woman or her partner can hold the outer ring. yy Woman can hold her partner’s penis and guide it into the condom. Outer ring slips inside the vagina or the condom is pushed into the vagina If this occurs during sexual intercourse, STOP! And insert a new female condom. Inner ring discomfort Remove female condom and reinsert to position differently. Condom riding out with penis Use more lubrication inside the female condom or directly on the penis. If the female condom comes out during sex, insert a new condom. Condom slips out of hand during insertion Remove excess lubrication. Suspected pregnancy Assess for pregnancy. A woman can safely use condoms during pregnancy for continued STI protection.
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Reference Manual for Doctors on Family Planning and Reproductive Health
Frequently asked questions regarding Female Condoms 1. Can female condoms prevent HIV?
Female condom is made of nitrile, a synthetic rubber, and has been tested to show that the HIV organism cannot pass through it.
2. Should female and male condoms be used at the same time for ‘double protection’?
Female and male condoms should never be worn at the same time. Using both at the same time can cause tearing or slipping in either condom.
3. Aren’t female condoms for sex workers and casual sex, and not married and long-term partners?
Female condoms can prevent unintended pregnancy and HIV in marriages and long-term relationships.
4. Can female condoms only be used in one sexual position – with the man on top and the woman on the bottom?
They can be used in different sexual positions as long as it is inserted correctly and the outer ring remains outside the vagina.
5. Are female condoms too big and baggy?
Female condoms are about the same length as the male condom but wider so they fit the inside of the vagina more comfortably. Some men prefer the looseness of the female condom to the snugness of the male condom.
6. Women will not be comfortable touching their vaginas in order to insert the female condom?
People used to say the same thing when tampons were first introduced, but over time and with practice these perceptions changed.
7. Do condoms reduce spontaneity?
Female condoms can be inserted some time before sexual intercourse so that sex can be spontaneous and pleasurable.
8. Female condoms will get lost in the vagina or uterus?
The vagina is a small closed pouch and the female condom cannot get lost in it. The opening to the cervix is far too small to allow a condom to pass through.
9. Can female condom be re-used?
No. It is not recommended to re-use male or female condoms.
10. Difficulty in persuading partner to use female condoms or not able to use a condom every time?
Discuss ways to talk with her partner about the importance of condom use for protection from pregnancy and STIs.
11. How to dispose female condom?
Female condom should not be flushed. It can be wrapped in paper and can go as household waste.
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Chapter 3: Reversible Contraceptives
3.2. Intrauterine Devices (IUD) Intrauterine contraceptive devices (IUDs or IUCDs) are small, flexible plastic devices that are inserted into the woman’s uterus. The most common IUDs contain copper, and they work primarily by causing a chemical change that damages sperm and egg before they can meet. Depending on the type, IUDs can provide protection for 5 to 12 years. Types of IUDs The different types of IUD now available are: I.
Copper-bearing IUDs: Made of plastic with copper sleeves and/or copper wire on the plastic, such as TCu-380A, MLCu-375.
II. Hormone-releasing IUDs: Made of plastic, steadily released small amounts of hormone progesterone or progestins such as levonorgestrol,
3.2.1 Copper-bearing IUD Mechanism of Action of Copper-bearing IUDs It works mainly by preventing the sperm and egg from meeting. The IUD makes it hard for sperm to move through the woman’s reproductive tract, which reduces the ability of sperm to fertilize an egg, or it prevents the egg from implanting in the wall of the uterus. Effectiveness of Copper-bearing IUDs Pregnancy rates for all major IUDs are less than one per 100 women per year. This means that of every 1000 women using IUDs only six to eight may become pregnant. IUDs are as effective as implants, injectable contraceptives and voluntary male and female sterilization. WHO trial suggests that after 10 years of use the cumulative pregnancy rate for CuT-380A was 2.1 per 100 women and for CuT-220C was 5.7.
Advantages yy A single decision to use an IUD leads to effective long-term prevention of pregnancy up to 10 years. yy Convenient to the user as no need of remembering anything once this is inserted. yy No interference with sex and any hormonal side effects of copper-bearing IUDs. yy Copper-bearing IUDs have no effect on quality or quantity of breast milk. yy Can be inserted immediately after childbirth or after induced abortion. yy Does not interfere with any medication. yy Prevent ectopic pregnancy (less risk of ectopic pregnancy than in women not using any contraceptive method). 26
Reference Manual for Doctors on Family Planning and Reproductive Health
yy No delay in return of fertility.
Limitations yy Menstrual Irregularities in early months, but this is reduced after three months. yy Does not protect against sexually transmitted diseases (STDs) including HIV/AIDS. yy Requires skilled provider, including pelvic examination is needed to insert IUD. yy Client cannot stop IUD use on her own. A skilled health care provider is required to remove the device. yy The IUD may come out of the uterus possibly without the woman knowing about it (more common when the IUD is inserted soon after childbirth). yy Does not protect against ectopic pregnancy. In general, many women can use IUD safely and effectively. IUDs can be used in any circumstances by women who: yy Are of any age including adolescents and women over 40 years. yy Have just had an abortion or miscarriage (if there is no evidence of infection or risk of infection). yy Take antibiotics or anticonvulsants. yy Are fat or thin or are breast feeding. yy Have or do not have any children. yy Are infected with HIV or are on ART. yy Have anaemia. Also, women with these conditions can use IUDs in any circumstances: yy Benign breast disease and breast cancer. yy Headaches. yy Irregular vaginal bleeding (after evaluation). yy Blood clotting problems and varicose veins. yy Heart disease (disease involving heart valve may require treatment with antibiotics before IUD). yy History of stroke, high blood pressure, diabetes, epilepsy. yy Liver or gall bladder disease and thyroid disease. yy Malaria and non-pelvic tuberculosis. yy Past ectopic pregnancy. yy Past pelvic surgery. 27
Chapter 3: Reversible Contraceptives
Medical Eligibility Criteria The following conditions are included under category 3 (method not recommended for use unless other more appropriate method is not available or not acceptable) and category 4 (method should not be used at all) yy Unexplained vaginal bleeding including endometrial, cervical cancer and ovarian cyst/tumours. yy Cervical lacerations, cervical stenosis (Initiation). yy Current STIs such as chlamydia and gonorrhoea (Initiation). yy Current pelvic inflammatory diseases (PIDs), increased risk of STIs. yy Pelvic tuberculosis. yy Immediate post-septic abortion. yy Clients on ART (Initiation).
IUD insertion A provider who listens to a woman’s concern, answers her questions, and gives clear, practical information about the side effects, especially probable bleeding changes and possible pain after insertion, will help the woman use the IUD with success and satisfaction. Provider must counsel the client about all available methods, share all information and allow the client to choose the method of her choice. All women who choose IUDs must have access to IUD removal on demand.
Broad Steps in Procedure »»
Proper infection prevention measures should be followed when inserting a new, presterilized IUD.
»»
‘No-Touch” technique is preferred.: “No-touch” technique includes: (1) Loading the IUD in the inserter while both parts are still in the sterile package; (2) Cleaning the cervix with antiseptic before IUD insertion; (3) Being careful not to touch the vaginal wall or speculum blades with the uterine sound or loaded IUD inserter; (4) Passing both, uterine sound and IUD inserter only once through the cervical canal.
»»
The woman is asked to tell the provider if she feels discomfort or pain at any time during the procedure. Ibuprofen may be given 30 minutes before insertion to reduce cramping and pain.
»»
Conduct a careful pelvic examination (speculum and bi-manual) and check the position of uterus to make sure that the woman can use an IUD safely and effectively.
»»
The provider carefully cleans the cervix and vagina several times with an antiseptic solution such as iodine.
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Working slowly and gently, the provider inserts the IUD, following the manufacturer’s instructions. 28
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»»
After the insertion, the provider asks client how she feels and, if she feels dizzy when sitting, suggests that she lie quietly for 5 or 10 minutes. Any cramping probably will not last long.
Postpartum insertion Postpartum uterus is a hollow organ with its inner walls spread apart. Following delivery cervix is dilated and flabby and outer margins are usually lacerated especially laterally. Postpartum contraction of the lower part of uterus, such anatomical changes occur that can cause a provider inserting IUD mistakenly and believe that fundus has been reached and that IUD is properly placed when it is not. Such insertions result in expulsion. Only providers who have special training should insert IUDs after childbirth. Proper insertion technique is important to reduce the risk of expulsion. An IUD can be inserted during – yy IUD can be manually inserted in first 10 minutes of delivery of placenta and instrumentation is required for insertions up to 48 hour such a Kelly forceps. Inserter should not be used as this may cause perforation. yy Following an abortion, if there is no infection, bleeding or any other contraindications yy Insertion any time after 6 weeks postpartum Follow-up visit of IUD user after a menstrual period, for check-up and pelvic examination to see positioning of the device and any sign of infection. After this one return visit, no further routine visits are required.
Removing the IUD yy Removing IUD is usually simple. It can be done anytime throughout the menstrual cycle. Removal may be somewhat easier during menstruation, when the cervix is dilated. yy Proper infection-prevention procedures are followed. yy The health care provider pulls the IUD strings slowly and gently with forceps. yy If removal is not easy, the provider may dilate the cervix using a uterine sound or alligator forceps or refer the client to a specially trained provider.
Common Side Effects 1. Some users may report changes in monthly bleeding including prolonged and heavy bleeding, irregular bleeding and cramps. Women need to be counseled about these side effects during
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pre-procedure counseling. She should be reassured that these problems would not last for more than three months. If these continue she should be properly evaluated and advised accordingly. 2. There is risk of PID if women have upper genital tract infections such as gonorrhea and chlamydia at the time of insertion. IUD does not lead to PID.
Correcting Some Common Misunderstandings about IUDs yy Does not increase risk of contracting STIs/HIV. yy Does not increase risk of miscarriage if women get pregnant after IUD removal. yy Do not make women infertile. yy Do not cause birth defects. yy Do not cause cancer. yy Do not move to heart or brain. yy Do not cause any pain during sex.
Counselling A woman who chooses an IUD should know what will happen during the insertion procedure. She also should understand the following: She can expect: yy Some cramping pain for first day or two after insertion. She can take Aspirin, Paracetamol or Ibuprofen. yy Some vaginal discharge for a few weeks after insertion. This is normal. yy Heavier menstrual periods. Possible bleeding between menstrual periods, especially during the first few months after IUD insertion. yy Checking the IUD: Sometimes IUDs come out. This can happen especially in first month or so after insertion or during a menstrual period. An IUD can come out without the woman feeling it.
Follow up Schedules Follow-up visit of IUD user in three to six weeks, after a menstrual period, for check-up and pelvic examination to see positioning of the device and any sign of infection. After this one return visit, no further routine visits are required.
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Make sure she knows: yy Exactly what kind of IUD she has and what it looks like. yy When to have IUD removed or replaced (for CuT-380A IUD, 10 years after insertion and 5 years CuT 375). Discuss how to remember the year to return. If she wants a new IUD, it can be inserted as soon as the old IUD is removed. yy When she visits health care providers, she should tell them that she has an IUD. yy Explain to her that she has right for removal of IUD if she is not happy with the method and help her switch to other method if she decides so. yy Provide the client with written record of month and year of IUD insertion and month and year when it should be removed.
Management of Irregular Bleeding, or Heavy Bleeding The prolonged bleeding means more than eight days and heavy bleeding implies twice as long or twice as much as usual for her. Conduct a Pelvic Examination to look for cervical disease, ectopic pregnancy, or PID. Refer for care if appropriate. She can continue using her IUD while condition is being evaluated. »»
If there is no evidence of infection or other abnormalities and less than three months since IUD insertion and bleeding is within normal and expected range.
Reassure her that changes in menstrual bleeding are normal and will probably lesson over time. Suggest food containing iron to eat if possible. If possible, give her iron tablets (ferrous sulfate up to 200 mg 3 times a day for 3 months). Ask if she wants to keep her IUD: »»
If she does, ask her to return in about three months for another check-up. If the bleeding bothers her, you may give her ibuprofen or other non-steroidal anti-inflammatory drugs (but not aspirin) to help her reduce it.
»»
If not, remove the IUD and help her choose another method.
If there is no evidence of infection or other abnormalities and more than three months since IUD insertion? »»
If the client wishes or if the bleeding or pain is severe, remove the IUD. Help her choose another method.
»»
If an abnormal condition is causing irregular or heavy bleeding, treat or refer for care.
»»
If very heavy bleeding, check for signs of severe anaemia—pale under fingernails and inside eyelids.
If found: »»
Recommend IUD removal and help her choose another method.
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»»
Give her enough iron tablets for three months
»»
If she wants to keep an IUD but has an inert IUD, replace it with a new copper-bearing IUD. Ask her to come for a check-up in three to six weeks.
Management of Complications among IUD users Management of lower abdominal pain that suggests pelvic inflammatory disease Diagnose: Take history and perform abdominal and pelvic examinations. If pelvic exam is not possible, do an external genital exam. If one or more of the following is found, refer to a capable provider at once »»
Missed a menstrual period, her period is late, or she is pregnant.
»»
Recently gave birth or had an abortion.
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Pain or tenderness when pressure is put on the abdomen during examination.
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A vaginal bleeding.
»»
A pelvic mass.
If she has none of the above conditions, diagnose as PID if she has one or more of the following (the more conditions she has, stronger the diagnosis) »»
Oral temperature of 38.30C (1010F) or higher.
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Abnormal vaginal or cervical discharge.
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Pain when moving the cervix during pelvic examination.
»»
Tenderness in the area of fallopian tube or ovary.
»»
Recent sex partner with urethral discharge or treated for gonorrhoea.
Note: Diagnosis may be difficult. PID signs and symptoms may be mild or absent. Also, the common signs and symptoms of PID often also occur with other abdominal conditions such as ectopic pregnancy or appendicitis.
yy Treat or immediately refer for treatment. Treat for gonorrhoea, chlamydia, and trichomoniasis— all three. yy General, remove the IUD if physical examination or laboratory tests point to PID. (Where PID management and follow up are possible, some experienced clinicians may leave the IUD in place). If diagnosis is uncertain and follow up is possible, treat with antibiotics without taking out the IUD, and watch carefully for results of treatment. If diagnosis is uncertain and follow up is not possible, take out the IUD and start antibiotics. yy Follow-up: If the woman does not improve in two or three days after starting the treatment, or if she develops a tubal abscess, she should be sent to hospital. Otherwise, schedule another follow up for just after she has finished taking all of her medicine. yy Urge the client to have her sex partner or partners come for STD treatment. 32
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Frequently asked questions 1. How a woman should perform a self-check of her IUD is in place?
Once a week during the first month after insertion, women should do a self-check to know the presence of IUD. In case of any symptoms of serious problems are noticed. IUDs are more likely to come out with menstrual blood after a menstrual period; therefore self-check is required from time to time.
To check her IUD, a woman should »»
Wash her hands with soap and water.
»»
Sit in squatting position.
»»
Insert one or two fingers in her vagina as far as she can until she feels the strings. She should return to the health care provider if she thinks the IUD might be out of place.
»»
She should not pull on the strings. She might pull the IUD out of place.
»»
Wash her hands again.
»»
After postpartum insertion, the strings do not always come down through the cervix.
2. If a current IUD user has a sexually transmitted infection or has is at very high individual risk of becoming infected with an STI, should her IUD be removed?
No. If a woman develops a new STI after her IUD has been inserted, she is not especially at risk of developing PID because of the IUD. She can continue to use the IUD while she is being treated for the STI. Removing the IUD has no benefit and may leave her at risk of unwanted pregnancy. Counsel her on condom use and other strategies to avoid STIs in the future.
3. Does the IUD make a woman infertile?
No. A woman can become pregnant once the IUD is removed just as quickly as a woman who has never used an IUD, although fertility decreases as women get older. Good studies find no increased risk of infertility among women who have used IUDs, including young women and women with no children. If an IUD user develops PID and it is not treated, there is some chance that she will become infertile.
4. Can a woman who has never had a baby use an IUD?
Yes. A woman who has not had children generally can use an IUD, but she should understand that the IUD is more likely to come out because her uterus may be smaller than the uterus of a woman who has given birth. Since insertion in nulliparous women as classified in category 2, it is advisable to have a qualified doctor doing the procedure.
5. Can young women and older women use IUDs?
Yes. There is no minimum or maximum age limit. An IUD should be removed after menopause has occurred—within 12 months after her last monthly bleeding.
6. Should a woman have a “rest period” after using her IUD for several years or after the IUD reaches its recommended time for removal?
No. This is not necessary, and it could be harmful. Removing the old IUD and immediately inserting a new IUD poses less risk of infection than two separate procedures. Also, a woman could become pregnant during a “rest period” before her new IUD is inserted.
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7. Should antibiotics be routinely given before IUD insertion?
No, usually not. Most recent research done where STIs are not common suggests that PID risk is low with or without antibiotics. When appropriate questions to screen for STI risk are used and IUD insertion is done with proper infection-prevention procedures (including the no-touch insertion technique), there is little risk of infection. Antibiotics may be considered, however, in areas where STIs are common and STI screening is limited.
8. Must an IUD be inserted only during a woman’s monthly bleeding?
No. For a woman having menstrual cycles, an IUD can be inserted at any time during her menstrual cycle if it is reasonably certain that the woman is not pregnant. Inserting the IUD during her monthly bleeding may be a good time because she is not likely to be pregnant, and insertion may be easier. It is not as easy to see signs of infection during monthly bleeding, however.
9. Do IUDs increase the risk of ectopic pregnancy?
No. On the contrary, IUDs greatly reduce the risk of ectopic pregnancy. Ectopic pregnancies are rare among IUD users. The rate of ectopic pregnancy among women with IUDs is 12 per 10,000 women per year. The rate of ectopic pregnancy among women in the United States using no contraceptive method is 65 per 10,000 women per year. On the rare occasions that the IUD fails and pregnancy occurs, six to eight of every 100 of these pregnancies are ectopic. Thus, the great majority of pregnancies after IUD failure are not ectopic. Still, ectopic pregnancy can be life-threatening, so a provider should be aware that ectopic pregnancy is possible if the IUD fails.
3.2.2. Hormone releasing IUD: Levonorgestrel-20 IUDs (LNG-20 IUDs) Levonorgestrel is a progestin widely used in implants and oral contraceptive pills. The levonorgestrel intrauterine device (LNG-IUD) is a T-shaped plastic device that steadily releases small amounts of levonorgestrel each day. LNG 20 is one of the newest forms of hormone-releasing IUDs. It contains 52 mg of levonorgestrel released at the rate of 20 micrograms per day and lasts for at least five years. It has been used for 10 years in Europe and is now considered to be an ideal method of contraception. Apart from preventing pregnancy, it also makes periods lighter, shorter and less painful. When it is removed, fertility returns immediately. LNG2 is particularly useful for two groups of women yy Women who have been pregnant and do not want any more children in next few years and yy Women their 30s and 40s who have completed their families and want a reliable long term method of contraception which they can use and then forget about for five years at a time.
Mechanism of Action The LNG IUD consists of plain device with a silastic reservoir attached to the vertical arm. The silastic reservoir is impregnated with levonorgestrel and is covered with a rate-limiting silastic membrane. The release rate of levonorgestrel is approximately 20 micrograms/24 hours for at least 5 years. LNG IUD acts as contraceptive in two ways: it makes cervical mucous much thicker, preventing
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sperm from getting through and it also thins out the endometrium hampering implantation. In some women, it also prevents ovulation. This mechanism of LNG IUD appears to be at the level of endometrium, where the high dose of local progestogen causes deciduation, epithelial atrophy and direct vascular changes.
Effectiveness The failure rate is low that it can be compared to sterilization. Long term studies show that among 100 women using LNG-20 IUD for one year, there will no more than two pregnancies. It is unique method of contraception combining the main benefits of the pill—effective birth control –with the main appeal of sterilization, “forget ability”. It also has an advantage over copper IUD because it tends to make periods lighter and shorter which the copper IUD does not.
Advantages yy More effective than copper-bearing IUDs. yy Most IUDs make woman’s period heavier, however the LNG IUD actual makes periods lighter than usual. yy Pelvic infection is less common with LNG IUD than copper-bearing IUDs. yy The Dominican Republic study found that women who used LNG -20 for more than three years were significantly less likely to have low serum ferritin or hematocrit than either women not using IUDs or women using un-medicated or copper-bearing IUDs. yy The studies have shown that the LNG-20 has had lower ectopic pregnancy rate than most copper IUDs. yy There are evidences that LNG IUD use among women with endometriosis decreased dysmenorrhoea and pelvic pain. yy Among women with heavy or prolonged bleeding, LNG IUDs are beneficial in treating menorrhagia.
Limitations yy It is costlier than copper-bearing IUDs. yy Can cause irregular bleeding or spotting in the first six months of use. yy Not suitable for women who are at risk of sexually transmitted infections or ectopic pregnancy.
Medical Eligibility Criteria Most of the medical eligibility criteria for copper-bearing IUDs and LNG IUD are similar; however, LNG IUD being the hormonal IUD the following are some of the major clarifications and additional eligibility criteria:
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yy In cases of cardiovascular disease and high blood pressure, there is some effect of hormone of LNG IUD. Hence, though it can be used, it definitely is not as safe as copper-bearing IUDs. yy In women with current deep vein thrombosis/pulmonary embolism, current history and migraine with aura of ischemic heart disease, the LNG IUD should be used only if other appropriate methods of contraception are not available or not acceptable. yy Among women with fibroids, there were no adverse health events with LNG IUD use and there was a decrease in symptoms and size of fibroids for some women. yy Due to presence of hormone, LNG IUD is not found suitable for women with current breast cancer. Even in women with past history of breast cancer, LNG IUD should be used only if other appropriate methods of contraception are not available or not acceptable. yy Due to hormone present in the LNG IUD in women with liver–related diseases it should be used only if other appropriate methods of contraception are either not available or not acceptable.
Timing of LNG IUD Insertion LNG IUD is inserted within a week of beginning of a period—this helps to reduce the chance of expulsion and irregular bleeding. It may be inserted immediately after a medical termination of pregnancy, but should be deferred until six weeks after delivery of a baby. The hormone effect on the uterine endometrium is reversed within a month and normal periods and fertility returns. The LNG IUD lasts for five years and if required, a new one could be inserted at the same time the old one is removed.
3.3. Hormonal Methods 3.3.1. Combined Oral Contraceptive Pills (COCP) Combined Oral Pills contains low doses of two hormones—a progestin and an estrogen—like the natural hormones progesterone and estrogen in a woman’s body. Combined oral contraceptives (COCs) are also called “the Pill,” low-dose combined pills, OCPs, and OCs. Types of Oral Contraceptives yy
Combined oral contraceptive pills »»
Low dose pills
»»
Very low dose pills
yy Progestreone only pills/Minipills
Mechanism of Action yy Inhibition of ovulation by suppressing FSH and LH. yy Alternation of endometrium to make it unsuitable for implantation even if the ovum is fertilized. 36
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yy Changes in cervical mucus which make it hostile for sperm.
Effectiveness Failure rate is 0.1 percent on correct and consistent use. Effectiveness depends on the user; risk of pregnancy is greatest when a woman starts a new pill pack three or more days late, or misses three or more pills near the beginning or end of a pill pack. When no pill-taking mistakes are made, less than one pregnancy per 100 women using COCs over the first year (3 per 1,000 women). No delay in return of fertility after COC is stopped. Certain medicines and supplements may make the pill less effective. These include: yy The antibiotic rifampin — other antibiotics do not make the pill less effective the antifungal Griseofulvin — other antifungals do not make the pill less effective. yy Certain HIV medicines. yy Certain anti-seizure medicines.
Medical Eligibility Criteria Women who have the following known conditions should not initiate COCs (contraindications): yy Breast feeding during the first six months postpartum. yy First three weeks postpartum and not breast feeding (six weeks postpartum if other risk factors for venous thromboembolism). yy Age 35 or older and smoke 15 cigarettes per day or more. yy Current breast cancer. yy Severe cirrhosis; malignant liver tumours; or benign liver tumours, with the exception of focal nodular hyperplasia (which is a tumour that consists of scar tissue and normal liver cells), gall bladder disease. yy Cardiovascular conditions (i.e., high blood pressure; diabetes with vascular complications; history of or current deep venous thrombosis, stroke, or ischemic heart disease). yy Migraine with aura or any migraine in women 35 or older. yy Taking drugs that affect liver enzymes: Rifampicin or Rifabutin (for tuberculosis), anticonvulsants (for Epilepsy), or Ritonavir (as part of an antiretroviral regimen). yy Any planned major surgery which is likely to make client bed ridden for one week or more.
Side Effects Generally not signs of a health problem; may diminish or change over time 37
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yy Headaches, dizziness yy Nausea yy Changes in bleeding pattern including scanty, irregular, infrequent or no monthly bleeding or spotting yy Breast tenderness yy Mood changes yy Amenorrhea
Combined Oral Contraceptives for Women with HIV yy Women can safely use COCs even if they are infected with HIV, have AIDS, or are on antiretroviral (ARV) therapy unless their therapy includes ritonavir. Ritonavir may reduce the effectiveness of COCs. yy Urge these women to use condoms along with COCs. Used consistently and correctly, condoms help prevent transmission of HIV and other STIs. Condoms also provide extra contraceptive protection for women on ARV therapy.
Counseling Women should be fully counseled about the method, how to take pills regularly, common side effects, what to do when pills are missed and when to come for management of common side effects. Additionally women should be made aware of the alternate sources of contraceptive supplies that may be available in the area. These are women controlled methods and can be stopped anytime, do not interfere with sex. Known health benefits include prevention of unwanted pregnancy, protection against endometrial and ovary cancer. The protection against cancers continues for 15 years after stopping use. The pills also reduce menstrual cramps, ovulation pain, excess hair on face, symptoms of poly cystic ovarian syndrome and symptoms of endometriosis.
COCs are Safe and Suitable for Nearly all Women yy Have or have not had any children. yy Are not married, any age yy Had an abortion. yy Smoke cigarettes and less than 35 years. yy Varicose veins
And Women can begin use COCs yy Without any pelvic examination,without any blood tests. yy Without cervical cancer screening. 38
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yy Without a breast examination. yy Even if a women is not having monthly bleeding at the time if it is reasonably certain that she is not pregnant.
Providing COCs After birth. If she is less than six months postpartum give her pills but also counsel her that pills should be started only after her baby is six months old or when breast feeding is no longer baby’s main food whichever is earlier. If she is not breast feeding and less than four weeks after giving birth, she can start any time on days 21-28. There is no need for any back up methods.
After abortion Immediately if she is starting within seven days of abortion. Need to use back up method for seven days if it is more than seven days after abortion. Show and explain pill pack. With 28 pills pack explain that last seven pills are of different colour and these do not contain hormones. She should take one pill each day until the pack is empty. She should start the next pack on the very next day. Sometime she may need to use a backup method if she misses a pill. Backup methods include condoms, and withdrawal.
Management of Common Side Effects Most side effects usually become less or stop within first few months. Skipping pills risks pregnancy and can make some side effects worse. It is advised to take pill at the same time every day to help reduce irregular bleeding and remember. Take pills with food or at bed time to avoid nausea. Irregular Bleeding Reassure the woman that this is not harmful and will stop after first few months of use. To reduce irregular bleeding, she should take the pill at the same time, can use Ibuprofen three times a day. If irregular bleeding continues for a long time or starts after several months of use, there may be something wrong for other reasons and consider underlying conditions and evaluation. No monthly bleeding Reassure her that blood is not building inside her body. This is not harmful.
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Ordinary Headaches Suggest Aspirin, Paracetamol or Ibuprofen. Headaches getting worse should be evaluated. Breast Tenderness Recommend wearing a supportive bra, try hot and cold compresses and pain relievers.
Frequently asked questions 1. What does a doctor advise; if women forget to take the pill?
Alternate method of birth control to be suggested if the woman has vaginal intercourse during the seven days after a missed pill. Some backup methods are the condom, female condom, diaphragm, or sponge. One can also use emergency contraception (morning after pill) up to five days after unprotected intercourse. Number of Pills Missed
When Pills Missed
What to do
Seven-Day Backup Needed?
Beginning of pack
Take a pill as soon as you remember. Take the next pill at the usual time. (This means you may take two pills in one day)
Yes
1–2 pills
Day 3–day 21
Take a pill as soon as you remember. Take the next pill at the usual time. (This means you may take two pills in one day)
No
3 or more pills
First two weeks
Take a pill as soon as you remember. Take the next pill at the usual time. (This means you may take two pills in one day)
Yes
3 or more pills
Third week
Do not finish pack. Throw away remaining pills. Start next pack.
Yes
Throw away the missed reminder pill(s). Take next reminder pill at the usual time.
No
First 1–2 pills
1–7 reminder pills Fourth week
2. Should a woman take a “rest” from COCs after taking them for a time?
No. There is no evidence that taking a “rest” is helpful. COCs can safely be used for many years without having to stop taking them periodically. A woman is protected only as long as she takes her pills regularly.
3. How long does it take to become pregnant after stopping COCs?
Women who stop using COCs can become pregnant as quickly as women who stop non-hormonal methods. The bleeding pattern a woman had before she used COCs generally returns after she stops taking them. Some women may have to wait a few months before their usual bleeding pattern returns.
4. Do COCs cause abortion?
No. Research on COCs finds that they do not disrupt an existing pregnancy. They should not be used to try to cause an abortion. They will not do so.
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5. Do COCs cause birth defects? Will the fetus be harmed if a woman accidentally takes COCs while she is pregnant?
No. Good evidence shows that COCs will not cause birth defects and will not otherwise harm the fetus if a woman becomes pregnant while taking COCs or accidentally starts to take COCs when she is already pregnant.
6. Do COCs cause women to gain or lose a lot of weight?
No. Most women do not gain or lose weight due to COCs. Studies find that, on average, COCs do not affect weight. A few women experience sudden changes in weight when using COCs. These changes reverse after they stop taking COCs. It is not known why these women respond to COCs in this way.
7. Do COCs change women’s mood or sex drive?
Generally, no. Some women using COCs report these complaints. The great majority of COC users do not report any such changes, however, and some report that both mood and sex drive improve. There is no evidence that COCs affect women’s sexual behavior.
8. What can a provider say to a client asking about COCs and breast cancer?
The provider can point out that both COC users and women who do not use COCs can have breast cancer. In scientific studies breast cancer was slightly more common among women using COCs and those who had used COCs in the past 10 years than among other women. Scientists do not know whether or not COCs actually caused the slight increase in breast cancers. It is possible that the cancers were already there before COC use but were found sooner in COC users.
9. Can COCs be used as a pregnancy test?
No. A woman may experience some vaginal bleeding (a “withdrawal bleed”) as a result of taking several COCs or one full cycle of COCs, but studies suggests that this practice does not accurately identify who is or is not pregnant.
10. Must a woman have a pelvic examination before she can start COCs or at follow-up visits?
No. Instead, asking the right questions usually can help to make reasonably certain that a woman is not pregnant. No condition that could be detected by a pelvic examination rules out COC use.
11. Can women with varicose veins use COCs?
Yes. COCs are safe for women with varicose veins. Varicose veins are enlarged blood vessels close to the surface of the skin. They are not dangerous. They are not blood clots, nor are these veins the deep veins in the legs where a blood clot can be dangerous (deep vein thrombosis). A woman who has or has had deep vein thrombosis should not use COCs.
12. Can a woman safely take COCs throughout her life?
Yes. There is no minimum or maximum age for COC use. COCs can be an appropriate method for most women from onset of monthly bleeding (menarche) to menopause.
13. Can women who smoke use COCs safely?
Women younger than age 35 who smoke can use low-dose COCs. Women age 35 and older who smoke should choose a method without estrogen or, if they smoke fewer than 15 cigarettes a day, monthly injectables. Older women who smoke can take the progestin-only pill if they prefer pills. All women who smoke should be urged to stop smoking.
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14. What if a client wants to use COCs but it is not reasonably certain that she is not pregnant after using the pregnancy checklist?
If pregnancy tests are not available, a woman can be given COCs to take home with instructions to begin their use within five days after the start of her next monthly bleeding. She should use a backup method until then.
15. Can COCs be used as emergency contraceptive pills (ECPs) after unprotected sex?
Yes. As soon as possible, but no more than five days after unprotected sex, a woman can take COCs as ECPs. Progestin-only pills, however, are more effective and cause fewer side effects such as nausea and stomach upset.
16. Is it important for a woman to take her COCs at the same time each day?
Yes, for two reasons. Some side effects may be reduced by taking the pill at the same time each day. Also, taking a pill at the same time each day can help women remember to take their pills more consistently. Linking pill taking with a daily activity also helps women remember to take their pills.
17. What are the health benefits of combined contraceptive pills? Fertility related benefits: yy
Prevention of pregnancy
yy
Offers protection against ectopic pregnancy
Menstrual benefits yy
Menstrual cycle stabilization
yy
Lesser iron deficiency anaemia due to lighter menstrual cycles
yy
More regular menstrual cycles
yy
Less dysmenorrhea
Other possible health benefits yy
Protection against pelvic inflammatory diseases
yy
Reduces risk of follicular cyst by 50% and corpus luteal cyst by 80%.
yy
Past contraceptive use protects women after they reach menopause where reduced risk of low bone mineral density was documented
yy
Reduction in acne
Protection from some cancers yy
Protection against cancers e.g. endometrial and ovarian cancer
yy
Protection against benign diseases e.g. benign breast diseases like fibrocystic and fibroadenomatosis disease decreased by 50-70%
18. What are the facts to be considered for women with HIV and AIDS using COC? yy
Women with HIV and AIDS can use COCs without restrictions.
yy
Women with AIDS who take antiretroviral drugs (ARVs) other than ritonavir can generally use COCs.
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(There is some evidence that ritonavir reduces the blood levels of contraceptive hormones to a much greater extent than other ARV drugs.) yy
Women with HIV who choose to use COCs should be counseled about dual method use and consider using condoms in addition to COCs. In addition to preventing the spread of HIV, condoms may be especially beneficial to women on ARVs because condoms provide additional protection from pregnancy in the event that COC effectiveness is reduced by ARVs.
3.3.2. Ultra Low dose COC Pills (Also called “Newer Pills�) Ethyle Estrodione (EE) + Drospirenone It is an equivalent to 25 mg of spironolactone. The major effect is anti-mineralocorticoid activity. By this property, drosiprenone decreases the salt and water retention, but it increases potassium retention. EE + Drospirenoneachieves the contraceptive action by suppressing gonadotropins, inhibiting ovulation and inducing changes in the cervical mucus and endometrium.
Advantages yy As a contraceptive it is 99 per cent effective if used correctly. yy It provides excellent cycle control. yy Low incidence of breakthrough bleeding and spotting. yy It is associated with lower incidence of symptoms associated with water retention such as headache, breast tenderness and weight gain. yy Suitable for females with features of hyper-androgenism.
Limitations yy In women with renal, hepatic or adrenal problems could predispose to hyperkalemia as this does not promote potassium excretion therefore associated with potassium retention. yy Risk of venous thromboembolism is similar as that of COC pills. The formulation is specifically beneficial for women susceptible to weight gain and rise in blood pressure. The combination gives excellent cycle control, good tolerability and a level of weight loss that may have a significant beneficial effect on compliance. EE + Cyproterone Acetate (CPA) Cyroproterone acetate is a synthetic progestogen derived from 17- alpha-hydroxy-progesterone with anti-gonadotrophic and anti-androgenic peripheral activity. It was first used in men for treatment of prostate cancer and was recognized in 1970 for its anti-androgenic property.
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Phase Having a menstrual cycle
Recommended Guidelines Within 5 days after start of her menstrual bleeding. No additional contraceptive protection is needed.
In between 2 menstrual Any day if she is reasonably certain that she is not pregnant. If it has been more cycles than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for next 7 days Amenorrhoea
She can start COCs at any time, if she is reasonably certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for next 7 days
Breast feeding
yy
If she is more than 6 months postpartum and amenorrhic, she can start COCs as advised above for any other amenorrhic woman
yy
If she is more than 6 months postpartum and her menstrual cycles have returned, she can start COCs as advised for other women having menstrual cycles
yy
Women less than 6 weeks postpartum who are primarily breast feeding should not use COCs. For women who are more than 6 weeks to 6 months postpartum and primarily breast feeding, use of COCs is usually not recommended unless other more appropriate methods are not available or not acceptable
yy
She can start COCs immediately, if she has been using her hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period.
yy
If her previous method was an injectable, she should start COCs when repeat injection would have been given. No additional contraceptive protection is required.
Switching from nonhormonal method
yy
She can start COCs within 5 days after the start of her menstrual bleeding.
yy
She can also start immediately or at any other time, if it certain that she is not pregnant. If it has been more than 5 days after the menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the next 7 days
Switching from IUD (including hormonal)
yy
She can start COCs within 5 days after the start of her menstrual bleeding. No additional contraceptive protection is required. The IUD can be removed at that time.
yy
She can also start immediately or at any other time, if it reasonably certain that she is not pregnant. If she has been sexually active during this menstrual cycle, and it has been more than 5 days since menstrual bleeding started, it is recommended that IUD should be removed at the time of her next menstrual period.
yy
She can start the pills in the first 7 days after first or second trimetser miscarriage or abortion
yy
Later at time when it is reasonably certain that she is not pregnant.
Switching to another hormonal method
After miscarriage or abortion
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Advantages yy Safe and reliable contraceptive. yy Excellent cycle and endometrial control. yy Additional benefit on hirsutism and acne. yy Control of polycystic ovarian syndrome. yy High psychological motivation due to its effect on androgenic skin disorders. yy Favourable effect on lipid and carbohydrate metabolism.
Limitations yy Nausea, headache and weight gain. yy Risk of venous thromboembolism associated with CPA/EE use is equivalent to that associated with the use of conventional COCs. yy Risk of developing venous thromboembolism resulting in hospital admission associated with anti-androgen oral contraceptive use is at least as high as with third generation use. CPA inhibits testosterone and di-hydro testosterone (DHT) action by binding competitively to intracellular receptors thus reducing nuclear concentration of free DHT. This also increases testosterone clearance. CPA is a potent anti-androgen hence is also used for treatment of women with acne/ hirsutism. As a contraceptive pill this pill is safe and well tolerated with mild side effects and excellent cycle control. This combination has also been used for the treatment of poly cystic ovarian syndrome. There is high psychological motivation due to its effect on and rogenic skin disorders. There is also favourable effect on lipid and carbohydrate metabolism. Common side effects are similar to conventional OCPs such as nausea, vomiting and headache. Risk of VTE is also similar to OCPs. Pills with Levonorgesterol
It is monophasic Ethinylestradiol + Levonorgestrel and represents a formulation that extends conventional oral contraceptive use from three weeks (21 tablets) of hormonal preparation and one week of placebo to 12 weeks (84 tablets followed by one week off.) It is suitable for women who are interested in just four periods a year for lifestyle or medical reasons.
Advantages yy Works like typical monthly pill. yy Ninety nine percent effective when used correctly.
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yy Once daily pill to be started day five of the cycle. yy Advantages of extended cycling and fewer scheduled periods especially suited for adolescents with medical problems worsened by periods and women with hectic lifestyle. yy Similar side-effects as conventional oral contraceptive pills. Conditions benefitting from extended cycle
yy Dysmenorrhoea yy Menorrhagia yy Premenstrual syndrome yy Iron deficiency anaemia yy Endometriosis yy Headaches yy Epilepsy yy Rheumatoid arthritis yy Coagulopathies yy Patients on anticoagulant therapy
Limitations yy Higher incidence of breakthrough bleeding and spotting which subsequently settles. yy Women need to be educated about pros and cons of suppression. yy Some women will benefit from suppression and others will consider it unnatural control. yy Newer pills have side effects similar to COCs apart from the specific ones mentioned earlier.
3.3.3. Progesterone-Only Pills (POPs) or Minipills About Progestin-Only Pills Pills that contain very low doses of a progestin like the natural hormone progesterone in a woman’s body. Do not contain estrogen, and so can be used throughout breast feeding and by women who cannot use methods with estrogen. Progestin-only pills (POPs) are also called “minipills” and progestin-only oral contraceptives. Progestin-only oral contraceptives are the best oral contraceptives for breast feeding women. They do not seem to reduce the milk production. The POPs can also be used for emergency contraception after unprotected sex. Mechanism of Action
yy Thickening of cervical mucous. yy Suppression of ovulation. 46
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yy Involution of endometrium. Effectiveness: 99.95 percent effective with correct and consistent use. Failure rate of only 0.5 percent in the first year in breast feeding women. The failure rates are higher in younger women than in women over 40 years. There is no delay in return of fertility after POP stopped.
Advantages yy Can be used by lactating mothers starting six weeks after childbirth. Quantity and quality of breast milk does not seem to be affected. yy No estrogen side effects. Do not increase risk of estrogen-related complications such as heart attack or stroke. yy Women take one pill every day with no break. Easier to understand than taking 21-day COCs. yy Can be very effective during breast feeding. yy Even less risk of progestin-related side effects, such as acne and weight gain, than with COCs. yy May help prevent benign breast disease, endometrial and ovarian cancer and pelvic inflammatory disease
Limitations yy For women who are not breast feeding common side effects- changes in menstrual bleeding are normal including irregular periods, spotting or bleeding between periods and amenorrhea or missed periods, possibly for several months. A few women may have prolonged or heavy periods. yy Less common side effects include headaches and breast tenderness. yy Need to be taken at about the same time each day to work best. yy Do not prevent ectopic pregnancy. The main comparative disadvantage of POPs-higher pregnancy rates than combined pills- is offset by the protection against pregnancy that breast feeding itself provides; during breast feeding ovulation is uncommon before menstruation resumes and may be irregular even after menstruation has resumed.
Side Effects yy Changes in bleeding patterns – lengthened post partum amenorrhoea, irregular and frequent bleeding, prolonged bleeding, no monthly bleeding. yy Headaches, nausea and dizziness. yy Breast tenderness and abdominal pains.
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Medical Eligibility for POPs In general, most women can use POPs safely and effectively. POP contraceptives can be used in any circumstances by women who: yy Are breast feeding (starting as soon as 6 weeks after childbirth) yy Have no children yy Are fat or thin yy Are of any age, including adolescents and over 40 yy Smoke cigarettes yy Have just had abortion or miscarriage Also, women with following conditions can use POP contraceptives in any circumstances: yy Benign breast disease yy Heavy, painful menstrual periods or iron deficiency anaemia yy Irregular menstrual periods yy Diabetes without vascular, kidney, eye or nerve disease yy Mild headaches yy Varicose veins yy Epilepsy yy Malaria and Schistosomiasis yy Sickle cell disease yy Thyroid disease yy PID & STD yy Endometriosis yy Benign ovarian tumour yy Uterine fibroids yy Past ectopic pregnancy yy Tuberculosis unless taking Rifampin
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Frequently asked questions 1. Can a woman who is breast feeding safely use POPs?
Yes. This is a good choice for a breast feeding mother who wants to use pills. POPs are safe for both the mother and the baby, starting as early as six weeks after giving birth. They do not affect milk production.
2. What should a woman do when she stops breast feeding her baby? Can she continue taking POPs?
A woman who is satisfied with using POPs can continue using them when she has stopped breast feeding. However, she is less protected from pregnancy than when breast feeding. She can switch to another method if she wishes.
3. Do POPs cause birth defects? Will the fetus be harmed if a woman accidentally takes POPs while she is pregnant?
No. Good evidence shows that POPs will not cause birth defects and will not otherwise harm the fetus if a woman becomes pregnant while taking POPs or accidentally takes POPs when she is already pregnant.
4. How long does it take to become pregnant after stopping POPs?
Women who stop using POPs can become pregnant as quickly as women who stop non-hormonal methods. POPs do not delay the return of a woman’s fertility after she stops taking them. The bleeding pattern a woman had before she used POPs generally returns after she stops taking them. Some women may have to wait a few months before their usual bleeding pattern returns.
5. If a woman does not have monthly bleeding while taking POPs, does this mean that she is pregnant?
Probably not, especially if she is breast feeding. If she has been taking her pills every day, she is probably not pregnant and can keep taking her pills. If she is still worried after being reassured, she can be offered a pregnancy test, if available, or referred for one. If not having monthly bleeding bothers her, switching to another method may help—but not to a Progestin-only injectable.
6. Must the POP be taken every day?
Yes. All of the pills in the POP package contain the hormone that prevents pregnancy. If a woman does not take a pill every day— especially a woman who is not breast feeding—she could become pregnant. (In contrast, the last 7 pills in a 28-pill pack of combined oral contraceptives are not active. They contain no hormones.)
7. Is it important for a woman to take her POPs at the same time each day?
Yes, for two reasons. POPs contain very little hormone, and taking a pill more than three hours late (more than 12 hours late with POPs containing Desogestrel 75 mg) could reduce their effectiveness for women who are not breast feeding. (Breast feeding women have the additional protection from pregnancy that breast feeding provides, so taking pills late is not as risky.) Also, taking a pill at the same time each day can help women remember to take their pills more consistently. Linking pill taking with a daily activity also helps women remember to take their pills.
8. Do POPs cause cancer?
No. Few large studies exist on POPs and cancer, but smaller studies of POPs are reassuring. Larger studies
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of implants have not shown any increased risk of cancer. Implants contain hormones similar to those used in POPs, and, during the first few years of implant use, have about twice the dosage.
9. Can POPs be used as emergency contraceptive pills (ECPs) after unprotected sex?
Yes. As soon as possible, but no more than five days after unprotected sex, a woman can take POPs as ECPs. Depending on the type of POP, she will have to take 40 to 50 pills. This is many pills, but it is safe because there is a very small quantity of hormone in each pill.
10. Do POPs change women’s mood or sex drive?
Generally, no. Some women using POPs report these complaints. The great majority of POP users do not report any such changes, however, some report that both mood and sex drive improve. It is difficult to tell whether such changes are due to the POPs or to other reasons. Providers can help a client with these problems (see Mood changes or changes in sex drive, p. 39). There is no evidence that POPs affect women’s sexual behaviour.
11. What should be done if a POP user has an ovarian cyst?
The great majority of cysts are not true cysts but actually fluid-filled structures in the ovary (follicles) that continue to grow beyond the usual size in a normal menstrual cycle. They may cause some mild abdominal pain, but they only require treatment if they grow abnormally large, twist, or burst. These follicles usually go away without treatment.
12. Do POPs increase the risk of ectopic pregnancy?
No. On the contrary, POPs reduce the risk of ectopic pregnancy. Ectopic pregnancies are rare among POP users. The rate of ectopic pregnancy among women using POPs is 48 per 10,000 women per year. The rate of ectopic pregnancy among women in the United States using no contraceptive method is 65 per 10,000 women per year. On the uncommon occasions that POPs fail and pregnancy occurs, 5 to 10 of every 100 of these pregnancies are ectopic. Thus, the great majority of pregnancies after POPs fail are not ectopic. Still, ectopic pregnancy can be life-threatening, so a provider should be aware that ectopic pregnancy is possible if POPs fail. Pregnancies among POP users are few, especially during breast feeding. When pregnancy occurs, however, as many as one in every 10 may occur outside the uterus.
13. When can a woman start POPs? When she is:
Instructions for initiating use
Having menstrual cycle
She can start POPs within 5 days after the start of her menstrual bleeding. No additional contraception is needed. She can also start POPs at any other time, it is reasonably certain that she is not pregnant. If it has been more than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the next 2 days.
Amenorrhic
She can start POPs, if it is reasonably certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next 2 days
Breast feeding
If she is between 6 weeks and 6 months postpartum and amenorrhic, she can start POPs at any time. If she is fully or nearly fully breast feeding, no additional contraceptive protection is needed. If she is more than 6 month postpartum and her menstrual cycle has returned, she can start POPs as advised for any other woman having their menstrual cycle. For women who are less than 6 weeks postpartum and primarily breast feeding, use of POPs is not recommended unless other appropriate contraceptive methods are not available or acceptable.
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When she is:
Instructions for initiating use
Switching from another hormonal method
She can start POPs immediately, if she has been using her hormonal method consistently and correctly, or if she is otherwise reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period. If her previous method was an injectable, she should start POPs when the repeat injection would have been given. No additional contraceptive protection is needed.
Switching from a nonhormonal method (Other than IUD)
She can start POPs within 5 days after start of her menstrual bleeding. No additional contraceptive protection is needed. She can also start immediately or any other time, if it is reasonably certain that she is not pregnant. If it has been more than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the next 2 days.
Switching from IUD (including hormonal)
She can start POPs within 5 days after start of her menstrual bleeding. No additional contraceptive protection is needed. The IUD can be removed at that time. She can also start immediately or any other time, if it is reasonably certain that she is not pregnant. If she has been sexually active in this menstrual cycle, and it has been more than 5 days since menstrual bleeding started, it is recommended at the time of her next menstrual period. If she has not been sexually active in this menstrual cycle and it has been more than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for next 2 days. If that additional protection is to be provided by the IUD she is using, it is recommended that this IUD be removed at the time of her next menstrual period. If she is amenorrhic or has irregular bleeding, she can start POPs as advised for other amenorrhic women.
14. What are the specific instructions to be given to the POP user?
The client should always take only one pill every day. If not breast feeding, it is best to take the pill at same time each day if possible, even taking a pill more than few hours late increases the risk of pregnancy, and missing two or more pills in a row greatly increases the risk.
Starting the next package
When she finishes one packet, she should take the first pill from the next package on the very next day. All pills are active, hormonal pills. There is no wait between packets.
If a woman forgets one or more pills
She should take one pill as soon as she remembers and then keep taking one pill each day as usual. »»
A breast feeding woman using progestin-only pills for extra protection is still protected if she misses pills.
»»
If more than three hours late in taking a pill, a woman who is not breast feeding or who is breast feeding but her menses have returned, should also use condoms or spermicide or else avoid sex for two days. She should also take last missed pill as soon as she can. Then she should keep taking one pill each day as usual.
Give advice on common problems
Describe the symptoms of problems that require medical attention. Serious complications of progestinonly pill are rare. Still a woman should see a doctor or nurse or return to the clinic if she has questions
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or problems or any of the following possible symptoms of more serious problems. POPs may or may not cause these problems: »»
Extremely heavy bleeding (twice as long as much as usual for her).
»»
Any very bad headaches that start or become worse after she begins to take POPs.
»»
Skin or eyes become unusually yellow.
»»
Might be pregnant (for example, missed period after several regular cycles), especially if she also has signs of ectopic pregnancy—abdominal pain, tenderness, or faintness. A woman who develops these signs must seek care at once.
Note on ectopic pregnancy Pregnancies among POP users are few, especially during breast feeding. When pregnancy occurs, however, as many as one in every 10 may occur outside the uterus. Ectopic pregnancy is lifethreatening and requires treatment at once.
Follow up POP users Helping clients at any routine return visit »»
Same as in COCs.
»»
If the client has developed active liver disease, if she has serious active liver disease, ask her to stop the pills, do not provide any further pills. Refer for care. Help her to choose a method without hormones.
»»
If she is taking medicine for seizures, Rifampicin or Griseofulvin, provide condoms or spermicide to use along with POPs. If she prefers, or if she is on long term treatment, help her choose another effective contraceptive method.
»»
If she has developed breast cancer, discontinue the pills and help her choose another non-hormonal contraceptive.
3.3.4. Emergency Contraceptive Pills (ECP) Emergency Contraception is a method of contraception that is used before missing a period to preventun wanted pregnancy. It is also called ‘morning after” or post-coital pills. EC Pills are safe and effective for the majority of women who may need these methods, as well as very simple to use. EC is useful in preventing unwanted pregnancy amongst adolescents. There is no evidence that knowledge and availability of this method has any effect on encouraging sexual activity. On the other hand, ECs bring then in contact with health systems so that use of regular contraception can be promoted. EC pills have an important role in helping couples achieve their reproductive intentions. Types of Emergency Contraception Pills
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The following methods can be used for emergency contraception: yy Emergency contraceptive pills (ECPs): Progestogen-only (0.75 mg LNG or 1.50 mg) or combined Oestrogen / Progestogen oral contraceptives (Yuzpe’s regime) yy In addition copper bearing IUDs also can be used as EC although this would require a skilled provider. Mechanism of Action Mainly stops ovulation (release of eggs from ovary) just as OCs taken daily would do, but perhaps also works in other ways. ECP does not interrupt an existing pregnancy. The probable mechanisms are: yy Inhibition or delay of ovulation. yy Thickening of cervical mucous. yy Direct inhibition of fertilization. yy Histological and biochemical alteration in endometrium leading to impaired endometrial receptivity to implantation of the fertilized egg. yy Alteration in transport of egg, sperm and embryo. yy Interference with corpus luteum function and luteolysis. Effectiveness Generally if no ECP is taken eight out of 100 women become pregnant. The sooner after intercourse that it is taken the more effective it is. EC pills prevent about 75 percent of unwanted pregnancies that would occur if no emergency contraception was used. Overall EC pills are little less effective than regular pills.
Safety Levonorgestrel-alone emergency contraception pills are very safe and do not cause abortion or harm future fertility.
Side Effects Side-effects are uncommon and generally mild. Nausea occurs among 20 percent clients using EC pills. This does not last more than 24 hours. Taking pills with food or milk may reduce nausea. Routine prophylactic anti-emetic is not recommended. Nearly five percent women may have vomiting. If vomiting occurs within two hours,same dose should be repeated. What pills can be used as Emergency Contraceptive Pills? yy ECP with Levonorgestrel only (Several dedicated products are available).
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yy Combined Estrogen and Levonorgestrel, or Ulipristal acetate. yy Progestin-only pills with Levonorgestrel or Norgestrel. yy Combined oral contraceptives with estrogen and a progestin— Levonorgestrel, Norgestrel, or Norethindrone (also called Norethisterone). When to Take Them? yy As soon as possible after unprotected sex. The sooner ECPs are taken after unprotected sex, the better they prevent pregnancy. yy Can prevent pregnancy when taken within 72 hours. These pills can be used for up to five days of exposure to unprotected sex, but for best results it is advisable to use in 72 hours. Who Needs Emergency Contraception? Any woman of reproductive age may need emergency contraception at some point to avoid an unwanted pregnancy. In What Situations Should Emergency Contraception be used? Emergency contraception can be used in a number of situations following sexual intercourse. yy When no contraceptive has been used. yy When there is a contraceptive failure or incorrect use, including: »»
Condom breakage, slippage, or incorrect use;
»»
Three or more consecutively missed combined oral contraceptive pills;
»»
The Progestogen-only pill (Mini pill) taken more than three hours late (or more than 12 hours late if taking a 0.75mg desogestrel-containing pill);
»»
Norethisterone Enanthate (NET-EN) Progestogen-only injection taken more than two weeks late;
»»
Depot-medroxyprogesterone acetate (DMPA) Progestogen-only injection taken more than four weeks late;
»»
The combined Estrogen-plus-progestogen monthly injection taken more than seven days late;
»»
Dislodging, delay in placing, or early removal of a contraceptive hormonal ring or skin patch;
»»
Dislodging, breakage, tearing, or early removal of a diaphragm or cervical cap;
»»
Failed withdrawal (e.g. ejaculation in the vagina or on external genitalia);
»»
Failure of a spermicide tablet or film to melt before intercourse;
»»
Miscalculation of the periodic abstinence method, or failure to abstain or use a barrier method on the fertile days of the cycle;
»»
Expulsion of an intrauterine contraceptive device (IUD) or hormonal contraceptive implant.
»»
In cases of sexual assault when the woman was not protected by an effective contraceptive method.
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Dosage WHO recommends Levonorgestrel for emergency contraceptive pill use. Ideally, this Progestogenonly method should be taken as a single dose (1.5 mg) within (72 hours) of unprotected intercourse. Alternatively, a woman can take the Levonorgestrel in two doses (0.75 mg each; 12 hours apart).
Medical Eligibility Criteria All women can use ECPs safely and effectively, including women who cannot use ongoing hormonal contraceptive methods. Because of the short-term nature of their use, there are no medical conditions that make ECPs unsafe for any woman.
Contraindications Emergency contraceptive pills should not be given to a woman who already has a confirmed pregnancy. However, if a woman inadvertently takes the pills after she becomes pregnant, the available evidence suggests that the pills will not harm either the mother or her fetus. Emergency contraceptive pills are for emergency use only and are not appropriate for regular use as an ongoing contraceptive method because of the higher possibility of failure compared with nonemergency contraceptives. In addition, frequent use of emergency contraception can result in sideeffects such as menstrual irregularities, although their repeated use poses no known health risks.
Counselling As with any other contraceptive method, EC pills should be provided in a manner that is respectful to clients and responsive to their need for information and care. The following points should be considered: yy Ensure visual and audio privacy. Confidentiality is critical. Provider should not make any judgmental comments and indicate disapproval. Supportive attitudes would encourage compliance and set the stage for follow up. yy Clients may be under stress because of fear of pregnancy, rape related trauma and concerns of STIs. Hence maintain a supportive environment. yy Frequent use. Emphasize that pills are for emergency use only and not recommended for routine use due to higher possibility of failures. Although frequent use is not recommended, repeat use poses no health risks and not a reason for denying access. yy Counsel that pills does not give any protection against STIs. yy Counsel about other contraceptive methods. yy Explain common side effects. yy Does not protect from pregnancy if there is unprotected sex in following days and week. yy Advise client to come back if menses are delayed for more than one week . 
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Frequently asked questions 1. Do ECPs disrupt an existing pregnancy?
No. ECPs do not work if a woman is already pregnant. When taken before a woman has ovulated, ECPs prevent the release of an egg from the ovary or delay its release by five to seven days. By then, any sperm in the woman’s reproductive tract will have died, since sperm can survive there for only about five days EC Pills do not displace an implanted embryo and cannot terminate an existing pregnancy.
2. Do ECPs cause birth defects? Will the fetus be harmed if a woman accidentally takes ECPs while she is pregnant?
No. Good evidence shows that ECPs will not cause birth defects and will not otherwise harm the fetus if a woman is already pregnant when she takes ECPs or if ECPs fail to prevent pregnancy.
3. How long do ECPs protect a woman from pregnancy?
Women who take ECPs should understand that they could become pregnant the next time they have sex unless they begin to use another method of contraception at once. Because ECPs delay ovulation in some women, she may be most fertile soon after taking ECPs. If she wants ongoing protection from pregnancy, she must start using another contraceptive method at once.
4. What oral contraceptive pills can be used as ECPs?
Many combined (estrogen-progestin) oral contraceptives and progestin only pills can be used as ECPs. Any pills containing the hormones used for emergency contraception —Levonorgestrel, Norgestrel, Norethindrone, and these Progestins together with Estrogen (Ethinyl estradiol) —can be used.
5. Are ECPs safe for women with HIV or AIDS? Can women on antiretroviral therapy safely use ECPs?
Yes. Women with HIV, AIDS, and those on antiretroviral therapy can safely use ECPs.
6. Are ECPs safe for adolescents?
Yes. A study of ECP use among girls 13 to 16 years old found it safe. Furthermore, all of the study participants were able to use ECPs correctly.
7. Can a woman who cannot use combined (estrogen-progestin) oral contraceptives or progestin-only pills as an ongoing method still safely use ECPs?
Yes. This is because ECP treatment is very brief.
8. If ECPs failed to prevent pregnancy, does a woman have a greater chance of that pregnancy being an ectopic pregnancy?
No. To date, no evidence suggests that ECPs increase the risk of ectopic pregnancy. Worldwide studies of Progestin-only ECPs, including a United States Food and Drug Administration review, have not found higher rates of ectopic pregnancy after ECPs failed than are found among pregnancies generally.
9. Why give women ECPs before they need them? Won’t that discourage or otherwise affect contraceptive use?
No. Studies of women given ECPs in advance report these findings: »»
Women who have ECPs on hand took them sooner after having unprotected sex than women who had to seek out ECPs. Taken sooner, the ECPs are more likely to be effective.
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»»
Women given ECPs ahead of time were more likely to use ECPs than women who had to go to a provider to get ECPs.
»»
Women continued to use other contraceptive methods as they did before obtaining ECPs in advance.
10. Should women use ECPs as a regular method of contraception?
No. Nearly all other contraceptive methods are more effective in preventing pregnancy. A woman who uses ECPs regularly for contraception is more likely to have an unintended pregnancy than a woman who uses another contraceptive regularly. Still, women using other methods of contraception should know about ECPs and how to obtain them if needed—for example, if a condom breaks or a woman misses three or more combined oral contraceptive pills.
11. If a woman buys ECPs over the counter, can she use them correctly?
Yes. Taking ECPs is simple, and medical supervision is not needed. Studies show that young and adult women find the label and instructions easy to understand. ECPs are approved for over-the counter sales or nonprescription use in many countries.
12. Women/couple may not use regular contraception if EC is available easily.
This is not true as per the studies.
13. Men would not use condoms if they know that their partners can use ECs.
Condom use prevents both unwanted pregnancy as well as infections. Men may be willing to rely on condoms if they know that ECs are available as a backup in the event of breakage and slippages.
3.3.5. Progestin only Injectable (POI) Progestin-only injectables contain a synthetic progestin like the natural hormone progesterone in a woman’s body. They do not contain estrogen. (Combined injectables contain both progestin and estrogen.) There are two types of POIs: yy DMPA (Depot Medroxy-progestron acetate): 150 mg every three months yy NET-EN (Norehisterone Enanthate): 200 mg every two months DMPA is the most widely used progestin-only injectable. DMPA is also known as the shot, the jab, the injection, Depo. These methods have been used by millions of women in more than 100 countries in the world in the last decades. Mechanism of Actions Progestin-only injectables work primarily by preventing ovulation (the release of eggs from the ovaries). Also,these thicken the cervical mucus, which prevents sperm from penetrating into the uterus and fallopian tubes and meeting an egg, and suppress endometrial growth, making the uterine lining unsuitable for implantation of a fertilized egg. DMPA has prolonged duration of action since progestin in released slowly from muscles. Who Can Use Progestin-Only Injectables? Nearly all women can use progestin-only injectables safely and effectively, including women who: yy Have or have not had children. 57
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yy Are not married or women of any age, including adolescents and women over 40 years of age yy Have just had an abortion or miscarriage. yy Smoke cigarettes, regardless of a woman’s age or number of cigarettes smoked. yy Are breast feeding (starting as soon as six weeks after childbirth). yy Have HIV or AIDS, regardless of whether they are taking anti-retroviral therapy. Health Risks and Benefits There are no known health risks of using progestin-only injectables. Known health benefits of progestin-only injectables include the following: yy DMPA protects against cancer of the lining of the uterus (endometrial cancer). yy DMPA protects against uterine fibroids. yy DMPA may help protect against symptomatic pelvic inflammatory disease. yy For women with sickle cell anaemia, DMPA reduces the frequency and pain of sickle cell crises. yy For women with endometriosis, DMPA reduces pain during menstrual periods, pain during intercourse, and pelvic pain and tenderness. yy Both DMPA and NET-EN may help protect against iron-deficiency anaemia. Effectiveness yy A highly effective contraceptive method with a typical pregnancy rate of about three percent during the first year of use (3 pregnancies per 100 women). In other words, 97 of every 100 women using Progestin-only injectables will not become pregnant during the first year of use. Effectiveness depends on having injections on time. Frequency and Timing of Injections yy Women using DMPA have an injection every three months (four times a year) and women using NET-EN have an injection every two months (six times a year). yy DMPA injections can be as much as two weeks early or up to four weeks late. NET-EN injections can be given as much as two weeks early or up to two weeks late.
Medical Eligibility Criteria POIs should not be given if she is breast feeding a baby less than six weeks, severe cirrhosis of liver, systolic blood pressure is more than 160 and diastolic more than 100 and diabetes for more than 20 years or damage to other systems, stroke, blood clots in legs, lungs heart attack or other serious heart problems, unexplained vaginal bleeding, had or have breast cancer and in presence of multiple risk factors for cardio-vascular diseases.
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Return to Fertility yy Fertility returns after a woman stops using injectables. However, return to fertility is often delayed on an average of 10 months after the last injection.
Side Effects yy Bleeding changes are common but not harmful. Most women have frequent or irregular bleeding at first and then little or no monthly bleeding. yy Gradual weight gain is common. Some women gain an average of one to two kilograms per year. Some users lose weight or have no significant change in weight. yy Some women who use progestin-only injectables report having headaches, dizziness, abdominal bloating and discomfort, mood changes, and less sex drive. yy There are some concerns abouthypo-oestrogenic effects of POIs in women below 18 years because of possible decrease in bone mass/density. Any obvious risk of osteoporosis should be taken in account (chronic Corticosteroid therapy) when advising them for POIs. POIs can be generally safe amongst adolescents as risks associated with unwanted pregnancies are higher than the oretical risk of osteoporosis later in life.
Sexually Transmitted Infections and HIV yy Injectable contraceptives do not prevent transmission of STIs, including HIV. Women at risk for STIs/HIV should also use condoms along with the injectables to prevent STI/HIV transmission. yy Injectable contraceptives are safe and effective for women who have HIV, including those who have AIDS and those taking antiretroviral medications.
When Can a Woman Begin Using Progestin-Only Injectables? No tests are necessary for a woman to being using progestin-only contraceptives. She can begin: yy Without a pelvic exam. yy Without any blood tests or other routine laboratory tests. yy Without cervical cancer screening. yy Without a breast examination. yy Even when she is not having monthly bleeding at the time, if it is reasonably certain a woman is not pregnant.
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Frequently asked questions 1. Can women who could get sexually transmitted infections use progestin-only injectables?
Yes. Women at risk for STIs can use progestin-only injectables. The few studies available have found that women using DMPA were more likely to acquire chlamydia than women not using hormonal contraception. The reason for this difference is not known. There are few studies available on use of NET-EN and STIs. Like anyone else at risk for STIs, a user of progestin-only injectables who may be at risk for STIs should be advised to use condoms correctly every time she has sex. Consistent and correct condom use will reduce her risk of becoming infected if she is exposed to an STI.
2. If a woman does not have monthly bleeding while using progestin-only injectables, does this mean that she is pregnant?
Probably not, especially if she is breast feeding. Eventually most women using progestin-only injectables will not have monthly bleeding. If she has been getting her injections on time, she is probably not pregnant and can keep using injectables. If she is still worried after being reassured, she can be offered a pregnancy test, if available, or referred for one. If not having monthly bleeding bothers her, switching to another method may help.
3. Can a woman who is breast feeding safely use progestin-only injectables?
Yes. This is a good choice for a breast feeding mother who wants a hormonal method. Progestin-only injectables are safe for both the mother and the baby starting as early as six weeks after childbirth. They do not affect milk production.
4. How much weight do women gain when they use progestin-only injectables?
Women gain an average of 1–2 kg per year when using DMPA. Some of the weight increase may be the usual weight gain as people age. Some women, particularly overweight adolescents, have gained much more than 1–2 kg per year. At the same time, some users of progestin-only injectables lose weight or have no significant change in weight. Asian women in particular do not tend to gain weight when using DMPA.
5. Do DMPA and NET-EN cause abortion?
No. Research on progestin-only injectables finds that they do not disrupt an existing pregnancy. They should not be used to try to cause an abortion. They will not do so.
6. Do progestin-only injectables make a woman infertile?
No. There may be a delay in regaining fertility after stopping progestin only injectables, but in time the woman will be able to become pregnant as before, although fertility decreases as women get older. The bleeding pattern a woman had before she used progestin-only injectables generally returns several months after the last injection even if she had no monthly bleeding while using injectables. Some women may have to wait several months before their usual bleeding pattern returns.
7. Does DMPA cause cancer?
Many studies show that DMPA does not cause cancer. DMPA use helps protect against cancer of the lining of the uterus (endometrial cancer). Findings of the few studies on DMPA use and breast cancer are similar to findings with combined oral contraceptives: Women using DMPA were slightly more likely to be diagnosed with breast cancer while using DMPA or within 10 years after they stopped. It is unclear whether these findings are explained by earlier detection of existing breast cancers among DMPA users or by a biologic effect of DMPA on breast cancer. A few studies on DMPA use and cervical cancer suggest that
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there may be a slightly increased risk of cervical cancer among women using DMPA for five years or more. Cervical cancer cannot develop because of DMPA alone, however. It is caused by persistent infection with human papillomavirus. Little information is available about NET-EN. It is expected to be as safe as DMPA and other contraceptive methods containing only a progestin, such as progestin-only pills and implants.
8. Can a woman switch from one progestin-only injectable to another?
Switching injectables is safe, and it does not decrease effectiveness. If switching is necessary due to shortages of supplies, the first injection of the new injectable should be given when the next injection of the old formulation would have been given. Clients need to be told that they are switching, the name of the new injectable, and its injection schedule.
9. How does DMPA affect bone density?
DMPA use decreases bone density. Research has not found that DMPA users of any age are likely to have more broken bones. However, when DMPA use stops, bone density increases again for women of reproductive age. Among adults who stop using DMPA, after two to three years their bone density appears to be similar to that of women who have not used DMPA. Among adolescents, it is not clear whether the loss in bone density prevents them from reaching their potential peak bone mass.
10. Do progestin-only injectables cause birth defects? Will the fetus be harmed if a woman accidentally uses progestin-only injectables while she is pregnant?
No. Good evidence shows that progestin-only injectables will not cause birth defects and will not otherwise harm the fetus if a woman becomes pregnant while using progestin-only injectables or accidentally starts injectables when she is already pregnant.
11. Do progestin-only injectables change women’s mood or sex drive?
Generally, no. Some women using injectables report these complaints, however the great majority of injectables users do not report any such changes. It is difficult to tell whether such changes are due to progestin only injectables or to other reasons. Providers can help a client with these problems (see Mood changes or changes in sex drive, p. 76). There is no evidence that progestin-only injectables affect women’s sexual behaviour.
12. What if a woman returns for her next injection late?
Revised WHO guidance recommends giving a woman her next DMPA injection if she is up to four weeks late, without the need for further evidence that she is not pregnant. A woman can receive her next NETEN injection if she is up to two weeks late. Some women return even later for their repeat injection. In such cases providers should assess for pregnancy. Whether a woman is late for reinjection or not, her next injection of DMPA should be planned for three months later, or her next injection of NET-EN should be planned for two months later, as usual.
13. What are the procedures for injection?
Dose-DMPA: 150 mg for injections into the muscle (intramuscular injection 8). NET-EN: 200 mg for injections into the muscle.
If possible, use single-dose vials. Check expiration date. If using an open multi-dose vial, check that the vial is not leaking. DMPA: A 2 ml syringe and a 21–23 gauge intramuscular needle. NET-EN: A 2 or 5 ml syringe and a 19-gauge intramuscular needle. A narrower needle (21–23 gauge) also can be used. For each injection use a disposable auto-disable syringe and needle from a new, sealed package (within expiration date and not damaged), if available.
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Hand Wash Wash hands with soap and water, if possible. If injection site is dirty, wash it with soap and water. No need to wipe site with antiseptic. Preparation of vial DMPA: Gently shake the vial. NET-EN: Shaking the vial is not necessary. No need to wipe top of vial with antiseptic. If vial is cold, warm to skin temperature before giving the injection. Pierce top of vial with sterile needle and fill syringe with proper dose. Inject formula Insert sterile needle deep into the hip (ventrogluteal muscle), the upper arm (deltoid muscle), or the buttocks (gluteal muscle, upper outer portion), whichever the woman prefers. Inject the contents of the syringe. Do not massage injection site.
14. How to dispose of disposable syringes and needles safely?
Do not recap, bend, or break needles before disposal. Place in a puncture-proof sharps container. Do not reuse disposable syringes and needles. They are meant to be destroyed after a single use. Because of their shape, they are very difficult to disinfect. Therefore, reuse might transmit diseases such as HIV and hepatitis. If reusable syringe and needle are used, they must be sterilized again after each use.
15. What is the management of side effects?
Problems reported as side effects may or may not be due to the method. »»
Problems with side effects affect women’s satisfaction and use of injectables. They deserve the provider’s attention. If the client reports side effects, listen to her concerns, give her advice and, if appropriate, treat.
»»
Offer to help the client choose another method now, if she wishes, or if problems cannot be overcome.
No monthly bleeding »»
Reassure her that most women using progestin – only Injectables stop having monthly bleeding over time, and this is not harmful. There is no need to lose blood every month. It is similar to not having monthly bleeding during pregnancy. She is not fertile. Blood is not building up inside her. (Some women are happy to be free from monthly bleeding)
»»
If not having monthly bleeding bothers her, she may want to switch to monthly injectables, if available.
Irregular bleeding (bleeding at unexpected times that bothers the client) »»
Reassure her that many women using progestin –only injectables experience irregular bleeding. It is not harmful and usually becomes less or stops after the first few months of use.
»»
For modest short term relief, take 800 mg Ibuprofen three times daily or 500 mg Mefenamic acid two times daily after meals for five days , beginning when irregular bleeding starts.
»»
If irregular bleeding continues or starts after several months of normal or no monthly bleeding , or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use.
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Weight gain Review diet and counsel as needed. Abdominal bloating and discomfort Consider locally available remedies. Heavy and prolonged bleeding (twice as much as usual or longer than 8 days) »»
Reassure her that some women using progestin- only injectables experience heavy or prolonged bleeding. It is not harmful and usually becomes less or stops after a few months.
»»
For modest short term relief she can try (one at a time): −−
Combined oral contraceptives (COCs), taking one pill daily for 21 days, beginning when heavy bleeding starts.
−−
50umg of Ethinyl estradiol daily for 21 days, beginning when heavy bleeding starts.
»»
If bleeding becomes a health threat or if the woman wants, help her choose another method. In the meantime, she can take ethinyl estradiol or COCs as above to help reduce bleeding.
»»
To help prevent anaemia, suggest she take iron tablets and tell her it is important to eat foods containing iron, such as meat and poultry (especially beef and chicken liver), fish , green leafy vegetables and legumes (beans, bean curd, lentils and peas).
»»
If heavy or prolonged bleeding continues or starts after several months of normal or no monthly bleeding, or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use
Ordinary headaches (non-migrainous) »»
Suggest Aspirin (325-650 mg), Ibuprofen (200-400 mg), Paracetamol (325-1000mg), or other pain reliever.
»»
Any headaches that get worse or occur more often during use of injectables should be evaluated.
Mood changes or changes in sex drive »»
Ask about changes in her life that could affect her mood or sex drive, including changes in her relationship with her partner. Give support as appropriate.
»»
Clients who have serious mood changes such as major depression should be referred for care.
»»
Consider locally available remedies.
Dizziness »»
Consider locally available remedies.
New problems that may require switching methods May or may not be due to the method. Migraine headaches »»
If she has migraine headaches without aura, she can continue to use the method if she wishes.
»»
If she has migraine aura, do not give the injection. Help her choose a method without hormones.
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Unexplained vaginal bleeding »»
Refer or evaluate by History and Pelvic examination. Diagnose and treat as appropriate.
»»
If no cause of bleeding can be found, consider stopping Progestin- only injectables to make diagnosis easier. Provide another method of her choice to use until the condition is evaluated and treated (not implants or a copper bearing or hormonal IUD).
»»
If bleeding is caused by sexually transmitted infection or pelvic inflammatory disease, she can continue using progestin- only injectables during treatment.
Certain serious health conditions (suspected blocked or narrowed arteries, liver disease, severe high blood pressure, blood clots in deep veins of legs or lungs, stroke, breast cancer, or damage to arteries, vision, kidneys, or nervous system caused by diabetes. »»
Do not give next injection.
»»
Give her a backup method to use until the condition is evaluated.
»»
Refer for diagnosis and care if not already under care.
Suspected pregnancy »»
Assess for pregnancy.
»»
Stop injections if pregnancy is confirmed.
There are no known risks to a fetus conceived while a woman is using injectables.
3.3.6. Combined Injectables Contraceptive (CIC) Injectable contraceptives are a highly effective, long-acting, reversible method of contraception. They contain synthetic steroid hormones that are usually given by injection into the muscle of a woman’s hip, upper arm, or buttocks, which are then released slowly into the bloodstream from the injection site. Injectable contraceptives include combined injectables and progestin-only injectables.
Combined Injectables CICs contain a short-acting Oestrogen and long –acting progesterone. Combined injectables are also called monthly injectables, CICs, and the injection. One formulation of combined injectables contains Medroxyprogesterone acetate (MPA) and Estradiol Cypionate; another formulation contains Norethisterone Enanthate (NET-EN) and Estradiol Valerate. MPA/estradiol Cypionate is marketed under the trade names Ciclofem, Ciclofemina, Cyclofem, CycloProvera. NET-EN/Estradiol Valerateis marketed under the trade names Mesigyna and Norigynon.
Mechanism of Action Combined injectables work primarily by preventing ovulation (the release of eggs from the ovaries). They also thicken the cervical mucus, preventing sperm from penetrating into the uterus and fallopian tubes and meeting an egg, and suppress endometrial growth, making the uterine lining unsuitable for implantation of a fertilized egg. 64
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Health Risks and Benefits Long-term studies of combined injectables are limited, but most researchers expect that health benefits and risks are similar to those of COCs. Combined injectables will protect against – yy Endometrial cancer yy Ovarian cancer yy Pelvic inflammatory disease yy Ovarian cysts yy Iron-deficiency anaemia and will yy Reduce menstrual cramps, menstrual bleeding problems, ovulation pain, excess hair on face or body yy Polycystic ovarian syndrome yy Endometriosis
Health risks of combined injectables include yy Deep vein thrombosis (Rarely) yy Pulmonary embolism (Rarely) A key difference between combined injectables and COCs is that combined injectables do not pass through the liver first because they are not taken by mouth like COCs. Short-term studies have shown that combined injectables have less effect than COCs on blood pressure, blood clotting, the breakdown of fatty substances (lipid metabolism), and liver function.
Effectiveness yy Ninety seven of every 100 women using injectables will not become pregnant during the first year of use. Effectiveness depends on returning on time for injections.
Frequency and Timing of Injections yy Women using combined injectables have an injection every month (12 times a year). yy Injections of combined injectables can be as much as seven days early or up to seven days late.
Return to Fertility Fertility returns after a woman stops using combined injectables. However, return to fertility is slightly delayed. Women take one month longer, on average, to become pregnant after stopping combined injectables than women who used methods other than injectables.
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Side Effects yy Bleeding changes are common but not harmful. Bleeding changes are less common among users of combined injectables compared with users of progestin-only injectables. Most women have frequent, irregular or prolonged bleeding during the first three months of use, but most have regular bleeding patterns after one year of use. About two percent of users have no monthly bleeding after one year of use. yy Gradual weight gain is common. Some women gain an average of one kilogram per year. Some users lose weight or have no significant change in weight. yy Some women report headaches, dizziness, and breast tenderness. yy Loss of bone mineral density is not a concern with combined hormonal methods, including combined injectables.
Sexually Transmitted Infections and HIV yy Injectable contraceptives do not prevent transmission of STIs, including HIV. Women at risk for STIs/HIV should also use condoms along with the injectables to prevent STI/HIV transmission. yy Injectable contraceptives are safe and effective for women who have HIV, including those who have AIDS and those taking most antiretroviral medications. Who can use Combined Injectables? Nearly all women can use combined injectables safely and effectively, including women who: yy Have or have not had children. yy Are not married. yy Are of any age, including adolescents and women over 40 years of age. yy Have just had an abortion or miscarriage. yy Smoke any number of cigarettes daily and are under 35 years old. yy Smoke fewer than 15 cigarettes daily and are over 35 years old. yy Have anaemia now or had anaemia in the past. yy Have varicose veins. yy Have HIV or AIDS, regardless of whether they are taking antiretroviral therapy.
Medical Eligibility Criteria CIC should not be used in the presence of: yy Breast feeding and less than six weeks postpartum. yy Past or present evidence of deep vein thrombosis or pulmonary embolism.
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yy Current and history of ischemic heart disease or stroke or Complicated Valvular heart disease. yy Major surgery with prolonged immobilization. yy Hypertension with vascular disease; Diabetes mellitus with vascular complications. yy Migraine with aura. yy Breast cancer within the past five years. yy Active viral hepatitis and malignant liver tumour and generally not used in presence of benign tumour. yy Smoking over 15 or more cigarettes daily aged 35 years or more. yy Hyperlipidemia, severe decompressed cirrhosis. When Can a Woman begin Using Combined Injectables? No tests are necessary for a woman to begin using combined injectables. She can begin: yy Without a pelvic exam yy Without any blood tests or other routine laboratory tests yy Without cervical cancer screening yy Without a breast examination Even when she is not having monthly bleeding at the time, if it is reasonably certain a woman is not pregnant. Injection technique yy Use only sterile or high-level disinfected syringes and needles. Disposable syringes and needles must not be re-used. yy Shake the vial thoroughly. (If the vial has been cooled warm it to room temperature first). yy Remove the protective the cap of vial carefully, so as not to contaminate the stopper. yy Aspirate contents into a sterile syringe to the exact volume required. yy Clean the injection site. yy Insert the sterile needle deep into the gluteal (upper outer quadrant) or deltoid muscle. (Many providers prefer to give oil-based injections only in the gluteal muscle to reduce any pain associated with injections). yy Do not massage the injection site. yy Dispose of the disposable needles and syringes as appropriate.
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Frequently asked questions 1. Who can provide CICs?
Any health care provider who has been trained in the education and counselling of clients and the administration of injectables may provide this method, depending on local regulations and practice.
2. How to administer initial injection to the client?
Give the initial injection within the first seven days of the menstrual cycle,preferably the first day. The client can also have the first injection at any other time, if it is reasonably certain that she is not pregnant. If it has been more than seven days since menstrual bleeding started she will need to abstain from sex, or use additional contraceptive protection for the next seven days.
For the amenorrhoeic client »»
The client can have the first injection at any time, if it is reasonably certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next seven days.
For the postpartum client »»
If the client is breast feeding and she wishes to use an injectable contraceptive, recommend the Progestogen-only injectable. CICs should not be used earlier than six months postpartum or before weaning.
»»
If the client is not breast feeding, she can receive the initial injection from three to six weeks postpartum. If the client wishes to start the CIC after the sixth week postpartum and she has not yet had the first postpartum period, rule out the possibility of pregnancy before giving the initial injection.
3. How to deal with a woman who is switching from another method to CIC? Switching from another hormonal method »»
The client can have the first injection immediately if she has been using her other hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period.
»»
If her previous method was an injectable contraceptive, she should start the CIC when the repeat injection would have been given. No additional contraceptive protection is needed.
Switching from a non-hormonal method (other than the IUD) »»
The client can have the first injection immediately if it is reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period.
»»
If she is within seven days the start of her menstrual bleeding no other contraceptive protection is needed.
»»
If it has been more than seven days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the next seven days.
Switching from an IUD (including a hormone-releasing IUD) »»
The client can have the first injection within seven days after the start of her menstrual bleeding. No additional contraceptive protection is needed. The IUD can be removed at that time.
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»»
»»
The client can also start the CIC at any time if it is reasonably certain that she is not pregnant. −−
If she has been sexually active in the current menstrual cycle, and it has been more than seven days since menstrual bleeding started, it is recommended that the IUD be removed at the time of her next menstrual period.
−−
If she has not been sexually active in the current menstrual cycle and it has been more than seven days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the next seven days. If that additional protection is to be provided by the IUD she is using, it is recommended that this IUD be removed at the time of her next menstrual period.
If she is amenorrhoeic or has irregular bleeding she can start CICs as advised for other amenorrhoeic women.
4. What is to be followed during repeat injection?
Regular repeat injections are essential if pregnancy is to be avoided. The client needs to have an injection every four weeks (approximately every month). Advise the client to visit the clinic as soon as possible if she islate for the next injection.
Re-injection interval »»
Provide repeat injections every four weeks (approximately monthly). −−
»»
If the client is early for an injection
When the standard four-week re-injection interval cannot be adhered to for any reason, the repeat injection can be given up to seven days early but may disrupt bleeding patterns. −−
If the client is late for an injection
»»
The repeat injection can be given up to seven days late without any need for additional contraceptive protection.
»»
If the client is more than seven days late for an injection she can have the injection if it is reasonably certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next seven days.
»»
She may wish to consider the use of emergency contraception if exposed to unprotected intercourse
5. What are the warning signs for a woman who is receiving CICs?
Advise the woman to consult or visit the clinic if pregnancy is suspectedor if any of the following problems occur: »»
Severe abdominal pain.
»»
Severe chest pain, cough or shortness of breath.
»»
Severe headache.
»»
Loss of vision or blurring.
»»
Severe pain in calf or thigh.
»»
Jaundice (yellowness of the eyes and skin).
»»
Unusually heavy bleeding.
»»
Unusual discomfort or problem at the injection site.
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To prevent anxiety in the client, explain to her that serious complications are very rare. You can inform her that her health will be better protected by use of this highly reliable method of contraception than if an unintended pregnancy were to occur.
Combined Injectable is soon going to be available in the market in India.
3.3.7. Implants Definition Implants (small plastic rods or capsules) are placed sub-dermally and release progestogen at a controlled rate, thus providing very small daily doses to achieve the desired contraceptive effect. A specifically trained provider performs a minor surgical procedure to place the implant under the skin on the inside of women’s upper arm. These do not contain oestogen and hence can be used during breast feeding. Available proprietary implants include the six-capsule Norplant (Seven years protection) the two-rod Jadelle (effective for five years). Sino implant, two rods and effective for four years and the one-rod Implanon effective for three years. The Norplant implant system is a highly effective, long-acting, reversible, low-dose progestogen-only contraceptive. The system consists of six slender, soft, silastic (silicone rubber) capsules. Each capsule is 2.4 mm in diameter and 34 mm in length, and contains 36 mg levonorgestrel. Approximately 30 ¾g Levonorgestrel a day is released and the effective life of the implant is seven years (unless the woman weighs more than 70 kg). Jadelle consists of two silastic rods which release Levonorgestrel and is effective for up to five years. Each rod is 43 mm long and 2.5 mm in diameter, and contains 75 mg levonorgestrel. Implanon is a single capsule which releases ethonogestrel and has a life span of three years. It is 40 mm in length and 2 mm in diameter, and contains 68 mg etonogestrel. Implants are inserted sub-dermally in the woman’s upper arm or forearm by a minor surgical procedure under local anaesthesia. After insertion, the implants are palpable but barely visible. Contraceptive effect is achieved by a slow, steady release of progestogen by diffusion through the silastic membrane into the bloodstream. Protection against pregnancy starts within 24 hours after insertion and lasts approximately seven years in the case of Norplant, five years for Jadelle, and three years for Implanon. Fertility is restored almost immediately after the implants are removed.
Mode of action As with other progestogen-only contraceptives, implants have two modes of action: yy The effect of the progestogen on cervical mucus is the main factor in its contraceptive efficacy. The mucus becomes viscous and scanty, thus inhibiting sperm penetration. yy The progestogen acts on the hypothalamus and pituitary and suppresses the LH surge responsible for ovulation. Ovulation is prevented in at least half of the cycles. In most cases the endometrium shows signs of suppression. However, this effect does not play an
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important role in the efficacy of progestogen implants because the changes in cervical mucus and anovulation would prevent fertilization.
Indications Progestogen-only implants, where available, should be provided to any woman who requests this method and who does not have any contraindication to its use, after appropriate counseling and reaching an informed decision. Progestogen-only implants are a suitable method for most women of reproductive age, but particularly indicated for women who: yy Want a highly effective method of contraception. yy Want a long-term contraceptive method. yy Desire a method that is not coitally related. yy Prefer a method that is not taken daily nor requires frequent re-supply. yy Have the desired number of children, but do not wish to be sterilized. yy Are considering sterilization, but are not yet ready to make a final decision. yy Should not use oestrogen-containing contraceptives. yy Have problems remembering to take oral contraceptives. yy Women with chronic problems whose health would be threatened with pregnancy. Implants are safe for use in all age groups, nulliparous women. Fertility return is immediate.
Medical Eligibility Criteria Historically, the contraindications to progestogen-only contraceptives were considered to be the same as for COCs. However, progestogen-only implants have no effect on blood pressure or coagulation factors (and therefore poses no risk of venous thrombosis), have a negligible effect on lipid metabolism and have very little effect on liver function. Thus contraindications for progestogenonly implants may be considered separately from those for COCs.
Contraindications Category 4 Progestogen-only implants should not be used in the presence of: yy Breast cancer within the past five years. Category 3 Do not advise the use of progestogen-only implants or provide them to women with:
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yy Present evidence of deep vein thrombosis or pulmonary embolism (DVT/PE). yy Active viral hepatitis. yy Severe decompensated cirrhosis. yy Benign or malignant liver tumour. yy History of breast cancer with no evidence of disease for the last five years. yy Breast feeding and less than six weeks postpartum. yy Unexplained vaginal bleeding suggestive of a serious underlying condition (before evaluation). yy Drug treatment affecting liver enzymes: rifampicin and certain anticonvulsants (Phenytoin, Carbamazepine, Barbiturates, Primidone, Topiramate, Oxcarbazepine). When any Category 3 condition is present explain to the client the potential risks and counsel her about alternative methods. If the client chooses a progestogen-only implant because other contraceptive options are not available or are unacceptable, it is particularly important that the method should be provided by a properly qualified practitioner and that the woman is kept under medical supervision. Category 2 Progestogen-only implants can generally be used with precaution in the presence of: yy Raised blood pressure (systolic ≼ 160 or diastolic ≼ 100 mmHg). yy Any history of hypertension where the blood pressure cannot be evaluated. yy Hypertension with vascular disease. yy Current and history of Ischaemic heart disease or stroke. yy Diabetes with or without complications (history of gestational disease is category 1). When any of these conditions is present, careful screening and appropriate monitoring will allow the benefits of using an implant to outweigh any potential risks. However, if a woman has more than one of the first five conditions above, which may increase the risk of arterial cardiovascular disease; it should be considered as category 3 of the medical eligibility criteria. If the client chooses an implant because other contraceptive options are not available or acceptable, it is particularly important to advise her that close medical follow-up is required. If the method is provided, record the woman’s special condition in the clinical record and advise her of warning signs relevant to her condition.
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Counselling Discuss the following points clearly with the client in language that she understands: yy The physical characteristics of the implants, how they are inserted and in which part of the body, and how they should feel under the skin. yy Advantages and disadvantages of implants including effectiveness and length of protection, risks and benefits, possible side-effects (particularly changes in menstrual pattern), the procedures of insertion and removal and cost. yy When implants should be removed. yy The importance of follow-up visits. yy After a client has chosen implants as her method of contraception make sure that she has understood the following points before insertion: »»
Possible changes in her menstrual bleeding pattern and the fact that these usually decrease with time.
»»
Side-effects and complications to watch out for.
»»
The importance of removal of the implant after its effective life span has expired (7 years for Norplant, 5 years for Jadelle, and 3 years for Implanon).
»»
Alternative family planning methods including information on effectiveness, risks and benefits, side-effects and cost as appropriate.
Choice of Implant The two newer sub-dermal implants Jadelle and Implanon are easier to insert and remove than Norplant. In general, when renewing a sub-dermal implant, service programmes should replace Norplant with Jadelle or Implanon. Selection of the implant will depend mainly on availability and cost, besides other factors.
Insertion and Removal Insertion Insert the sub-dermal implant within the first seven days of the menstrual cycle. No additional contraceptive protection is needed. The client can also have the implant inserted at any other time, if it is reasonably certain that she is not pregnant. If it has been more than seven days since menstrual bleeding started she will need to abstain from sex, or use additional contraceptive protection, for the next seven days. For the amenorrhoeic client yy The client can have the implant inserted at any time, if it is reasonably certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next seven days. 73
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For the postpartum client yy If the client is breast feeding and she wishes to use a progestogen-only sub-dermal implant, insert the implant from the sixth week postpartum, but not earlier. If she is between six weeks and six months postpartum and amenorrhoeic, she can have the implant inserted at any time. If she is fully or nearly fully breast feeding no additional contraceptive protection is needed. yy If the client is not breast feeding she can have the implants inserted immediately or at any time within the first six weeks postpartum. If the client requests the implant after the sixth week postpartum and she has not yet had the first postpartum period, rule out the possibility of pregnancy before inserting the initial implant. Immediately or in first seven days after first or second trimester abortion Basic principles for insertion and removal yy Insertion and removal should only be performed by health personnel specially trained in these procedures. yy Proper insertion techniques are important to ensure ease of removal. yy Perform insertion and removal only in a properly equipped clinical facility. yy Maintain strict sterile techniques. yy Before and during the insertion procedure, tell the woman what will happen during this procedure and encourage her to ask questions. yy Explain to her that she may feel some discomfort during some of the steps.
Indications for Removal of Sub-dermal Implants yy User request: Remove the implants without unnecessary delay when the client makes a firm request for it to be done. yy Pregnancy: Remove the implants as soon as pregnancy is confirmed. yy Medical reasons such as: »»
Heavy menstrual bleeding.
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Repeated severe headache or migraine-type headache occurring for the first time.
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Symptoms of acute liver disease.
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Serious infection of insertion site not amenable to treatment with antibiotics and/or local measures.
yy At the end of 7/5/3 years after insertion: If the woman wishes to continue with the method, you can insert a new set of implants after removing the old set.
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Instructions to the Client Provide all instructions clearly and in a language appropriate to the background of the client.
Instructions after Insertion yy After the effect of the local anaesthetic has worn off, there may be some discomfort and/or swelling at the site of insertion for one to two days. yy The woman must keep the site of insertion dry for four days. yy The gauze should be removed after three days and the bandage removed on the fifth day. yy The contraceptive effect of the implant starts soon after the capsules are inserted, so intercourse can be resumed the day after insertion.
Side Effects yy Advise the client about possible side effects, change in the menstrual bleeding, light spotting, continuous and irregular bleeding or amenorrhea, headache, enlargement of ovaries dizziness, skin rash and change in appetite yy Most side effects would go away in one year.
Warning signs Advise the client to make contact with the clinic or to return immediately if any of the following problems occur: yy Pain, pus or bleeding at the site of insertion. yy Expulsion of the implant. yy Unusually heavy vaginal bleeding. yy Menstrual bleeding has not occurred within six weeks after the previous menstrual period. yy Severe abdominal or pelvic pain. yy New or severe headaches. yy Yellow eyes or skin. yy Shortness of breath or severe chest pains. To prevent anxiety in the client, explain to her that serious complications are very rare. You can mention that her health will be better protected by using this highly reliable method of contraception than if an unintended pregnancy were to occur.
Follow-up Give the client the date of the next visit (within 1 month). Explain that the implant should be removed after 7/5/3 years and tell her the month and the year when it should be done. Also explain to her the 75
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importance of another clinic where there is staff trained to perform the removal. This information, the list of warning signs, and the name, address and telephone number of the clinic, can be put on a card or leaflet and given to the client. This should be written and presented in such a way that the client or somebody close to her (in case she cannot read) can readily understand it.
Removal If the client has any problems with the subcutaneous implant or if she wishes its removal, she must return to a clinic which provides implant removal services by trained providers.
Follow-up Care The client should be seen within one month after insertion, mainly to check the insertion site and to discuss any questions or concerns that she may have. Thereafter she should be seen at least annually. The client should be given the option to attend the service delivery site most convenient to her, provided that the site has staff properly trained in implant services.
Annual Follow-up Protocol yy Update the client’s address and how to make contact with her. yy Assess the client’s satisfaction with this method of contraception. yy Determine if the client has had any problems or side effects and, if so,record them in the clinical record. Update the medical history. yy Perform a physical assessment including: »»
Blood pressure
»»
Breast examination (with instruction for self-examination).
»»
A bimanual pelvic examination, with a cervical smear if this is due and possible.
yy Provide appropriate counseling and/or treatment as required. yy Review with the client the warning signs and instructions given at the previous visit, particularly the need for removal (at 7 years if using Norplant, at 5 years if using Jadelle or at 3 years if using Implanon), and the need to return to the same clinic or another competent clinic for removal (give information on that clinic if applicable). Give instructions for annual follow-up.
Side Effects yy The most frequent side-effect is disruption of the menstrual cycle. This includes prolonged bleeding, spotting between periods or amenorrhoea. In general, the total monthly blood loss is less than in a normal menstrual period, but some women may experience heavy bleeding. yy Changes in menstrual bleeding patterns (breakthrough bleeding and spotting) are common, especially during the first year of use. They are often temporary, and are rarely a risk to health. Careful counseling of women starting to use sub-dermal implants has reduced the numbers 76
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who discontinue this method because of these side effects. Clients who are fully informed beforehand about what to expect will be better able to understand and cope with these and other side effects, and this method usually results in a high degree of satisfaction among women. If the problem persists or if bleeding becomes too heavy, gynaecological problems should be excluded. If an STI or PID is diagnosed, the client can continue to use implants while receiving treatment, and should be counseled on condom use. If no gynaecological problems are found treatment with Ethinyl Oestradiol, low-dose combined oral contraceptives or nonsteroidal anti-inflammatory drugs may be tried. If this treatment is not effective and the problem becomes a threat to the health of the woman or is not acceptable to her, the use of implants should be discontinued. Help her to choose another method of contraception. yy Headache is the second most frequent complaint. Less common side effects include nervousness, nausea, dizziness, weight gain and skin side effects such as acne. yy If any capsules are expelled (a rare problem), replace them with new capsules as soon as the area is healed. Provide an interim back-up method of contraception.
Service Management Progestogen-only sub-dermal implants require special attention by programme managers, mainly because use of this method requires a surgical procedure, long-term follow-up and readily available facilities for removal. Sexual Reproductive Health/family planning services therefore require the availability of a well-designed information, education and communication system; suitable clinical facilities; the establishment of training centres; and appropriate record-keeping and client follow-up systems.
Client Records and Follow-up A record-keeping system which assures an up-to-date clinical record for each implant user is required. All client records should include findings from clinic assessment as well as insertion details. The record-keeping system should include a register for scheduled removals, and a mechanism for tracking clients so that the removal at 7/5/3 years may be accomplished in a timely fashion. The programme should have a system to ensure proper follow-up of all clients, including procedures to remind them to return to the clinic for check-ups and for removal at the end of the 7/5/3-year period.
Clinical Facilities Facilities should: yy Be sufficient for any demand which may be generated. yy Ensure permanent access to removal on demand for users. yy Have the essential equipment for insertion and removal. yy Have access to steam autoclave and other facilities for decontamination, cleaning and sterilization of equipment. yy Have permanent availability of trained staff. 77
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Storage, Shelf-life and Supplies yy Store implants at room temperature away from excess heat and moisture. yy Shelf-life is five years when stored as above.
Availability in India The Indian Council of Medical Research (ICMR) has conducted trials with the single rod implant; Implanon. The product is to be licensed for use in India soon. 
Frequently asked questions 1. Why should family planning programmes consider providing implants?
Hormone-releasing sub-dermal implants are a highly safe, acceptable, effective, and reversible form of contraception. Implants prevent pregnancy for an extended period of time after a single administration; no regular action by the user and no routine clinical follow up are required. Implants have high continuation and client satisfaction rates
2. What are contraceptive implants?
Contraceptive implants are small, thin, flexible plastic rods, each about the size of a matchstick, that are inserted under the skin of a woman’s upper arm and release a progestin hormone into the body. The most common types include Implanon (one rod containing 68 mg of progestin etonogestrel); Jadelle (two rods, each containing 75 mg of levonorgestrel); and Sino-implant (II) (two rods, each containing 75 mg of levonorgestrel), which is currently marketed as Zarin in much of Africa. Norplant (a six capsule system) is no longer available as of 2008.
3. How do implants work?
The progestin hormone released by the implants prevents pregnancy by thickening the cervical mucus, which blocks sperm from meeting an egg. Varying levels of ovulation suppression also occurs, depending on the type of implant used.
4. Do implants interrupt a current pregnancy?
No. Implants do not interrupt an existing pregnancy, nor will they harm the fetus in the unlikely event that pregnancy occurs during use
5. How effective are contraceptive implants?
Implants are one of the most effective reversible methods ever developed, comparable to intrauterine devices (IUDs), as well as female and male sterilization. Overall, in three years of Implanon use, less than one pregnancy per 100 users can be expected. In five years of Jadelle use, 1.1 pregnancies per 100 users can be expected. In four years of use of Sino-implant (II), the cumulative pregnancy rate is 0.9-1.06 percent. In general, long-acting methods, including implants, are more effective in practice than shorter acting methods, including oral contraceptives and injectables, because compliance and continuation rates are higher with methods that do not require regular action by the user
6. How effective are implants if they are kept in place beyond the time period of labelled use?
Manufacturers decide on the duration of labelled use when they pursue product registration. However,
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clinical evidence suggests implants still remain effective beyond these time periods. According to this evidence, when use is extended by at least an additional year, pregnancy rates for Implanon, Jadelle and Sino-Implant remain below 1-2 percent, depending on the type of implant. This compares favourably to pregnancy rates associated with common use of other reversible methods of contraception, such as COCs (8 percent), progestin-only injectables (3 percent) and condoms (15 percent).
7. Who can use contraceptive implants?
Implants can be used by women from menarche to menopause. Many women can safely use implants including lactating mothers, HIV-positive women, cigarette smokers of any age, post-abortion women, diabetic women, women at risk for cardiovascular disease (including those with high blood pressure), and adolescents. Studies have shown that use of the implant has no impact on breast feeding or on the healthy development of breast-fed babies. Implants can be initiated immediately after childbirth if a woman is not breast feeding, and six weeks postpartum if a woman is partially or fully breast feeding (WHO, 2004).
8. What are the other major advantages of contraceptive implants?
Implants offer women a number of advantages that can suit their reproductive intentions and that make continued use easy: »»
Convenience
»»
Immediate return to fertility
»»
Any side effects resolved immediately after removal
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No known health risks
»»
Suitable for nearly all women
9. What do good implant services include?
Good implant services require a competent and well-prepared staff that can perform insertion and removal procedures and can help clients make an informed choice about implants. Programmes can prepare providers to insert and remove implants through competency-based training. Providers can help clients interested in implants by: counseling them about side effects with an emphasis on bleeding changes; screening clients for conditions which may preclude safe use of implants; describing and answering questions about insertion and removal; and determining whether the client can have implants inserted immediately. Programmes should also ensure women’s access to removal services (Ramchandran & Upadhyay, 2007; WHO, 2007; WHO, 2009).
10. Who can provide implants?
Many different cadres of health care professionals can safely provide implants if they are thoroughly trained. These include nurses, nurse-midwives, nurse-practitioners, midwives, physicians, and physicians’ assistants and associates; in some countries, community health workers are also being trained to insert implants (Chikamata, 2002; WHO, 2007).
11. How is Implanon inserted?
Implanon comes packaged in a specially designed applicator. The provider identifies the location for insertion on the inner side of the upper arm. After injecting local anesthetic, the provider uses the needle of the pre-loaded applicator to puncture the skin and places the single implant under the skin.
12. What are the most commonly used techniques for removal of implants?
There are two commonly used techniques for removing new implants. With the “pop-out” technique, the
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provider first feels the site to ensure that the implant(s) can be located underneath the skin. The provider then makes a small incision at the lower (distal) end of the implant, pushes the implant gently towards the incision until the tip is visible, and then removes it with forceps. The “U” technique was developed for use when Norplant proved difficult to remove and also to make routine removals easier. The technique involves the use of an oval-ring-tipped forceps with an internal diameter of 2.2 mm to reach through a 4 mm incision to firmly grasp and remove each of the capsules (Rosenberg et al., 1997).
13. How important is it to counsel clients considering implants about bleeding changes?
It is very important to counsel clients about bleeding changes, in easily understandable,appropriate language (and to ascertain that the client has understood what she is being told). Bleeding changes are the most common reason that women cite for discontinuing implants. For example, in a Norplant study in Senegal, women who perceived their counseling to be “thorough”—that is, counseling included discussion of side effects and of other contraceptive options—were less likely than other women to discontinue use of implants when bleeding changes did occur (Ba et al., 1999). Providers can explain that bleeding changes are usually harmless and in most cases diminish over time. Every client should understand that she is welcome to come back to consult with the provider at any time. If the bleeding changes are not acceptable to the client, she should always have the option of switching to another, more acceptable method (WHO, 2007).
14. Why should clinics have a clear policy on removal?
Access to services for implant removal, or lack of access to removal, could strongly influence public perceptions of implants. Providers and family planning programmes could be considered coercive if women cannot have implants removed whenever they want to have them removed. Clinics that offer implants should develop and communicate a clear policy on removal that states the following: »»
Whenever a woman wants her implant(s) removed, she should be able to have them removed promptly free of charge or at an affordable price, without undue waiting, regardless of where or when the implants were inserted.
»»
A woman should not feel pressured to keep her implant(s). They should be removed whatever her reason, whether it is personal or medical.
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3.4. Combined Vaginal Rings Combined Vaginal Ring a flexible ring placed in the vagina. Continuously releases two hormones–a progestin and an estrogen, like the natural hormones progesterone and estrogen in a woman’s body–from inside the ring. Its effectiveness depends on the user: Risk of pregnancy is greatest when a woman is late to start a new ring. The combined vaginal ring is new, and research on effectiveness is limited. Effectiveness rates in clinical trials of the vaginal ring suggests that it may be more effective than combined oral contraceptives, both as commonly used and with consistent and correct use
Mechanism of Action Hormones are absorbed through the wall of the vagina directly into the bloodstream. Over the course of three weeks, the device releases a continuous low dose of estrogen and progestin. Higher estrogen and progestin levels signal the brain not to release the hormones that cause egg maturation. Without an egg ready to be released into the fallopian tube, ovulation cannot occur. The ring should be removed three weeks after insertion, on the same day of the week as it was inserted. Generally menstrual period will usually start two to three days after removal of Ring. After a oneweek break, a new ring is to be inserted. It is important that you insert a new ring on the same day of the week as it was removed in the last cycle, even if your menstrual period has not stopped. The ring is kept in place for three weeks, and then removed for the fourth week. During this fourth week the woman will have monthly bleeding. Works primarily by preventing the release of eggs from the ovaries
How to use Explain how to insert the ring yy She can choose the position most comfortable for her—for example, standing with one leg up, squatting, or lying down. yy She should press opposite sides of the ring together and gently push the folded ring entirely inside the vagina. yy The exact position is not important, but inserting it deeply helps it to stay in place, and she is less likely to feel it. The muscles of the vagina naturally keep the ring in place. Explain that the ring must be left in place for three weeks yy She should keep the ring in place all the time every day and night for three weeks. yy She can take the ring out at the end of the third week and dispose of it in a waste receptacle. yy She should wash her hands clean and dry before taking out ring from the foil.
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She should take out the ring for the fourth week yy To remove the ring, she should hook her index finger inside it, or squeeze the ring between her index and middle fingers, and pull it out. yy She will probably have monthly bleeding this week. yy If she forgets and leaves the ring in for as long as a fourth week, no special action is needed. yy Never dispose of the ring in the toilet. Ring should never be left out for more than three hours until the fourth week. yy The ring can be removed for sex, cleaning, or other reasons, although removing it is not necessary. yy If the ring slips out, she should rinse it in clean water and immediately reinsert it.
Instructions for Late Replacement or Removal yy Left ring out for more than three hours during weeks one or two »»
Put the ring back in as soon as possible. Use backup method* for the next seven days.
yy Left ring out for more than three hours during week three »»
Stop the current cycle and discard the ring.
»»
Insert a new ring immediately and keep it in place for three weeks, starting a new cycle. Use a backup method for the next seven days.
(Another option, if the ring was used continuously and correctly for the past seven days: Leave the ring out and make the next seven days the week with no ring. After those seven days, insert a new ring, starting a new cycle, and keep it in place for three weeks. Use a backup method for the first seven days with the new ring.) yy Waited more than seven days before inserting a new ring, or kept ring in longer than four weeks »»
Insert a new ring as soon as possible and begin a new four-week cycle. Use a backup method for the first seven days of ring use.
»»
Also, if a new ring was inserted three or more days late (ring was left out for 10 days or more in a row) and unprotected sex took place in the past five days, consider taking emergency contraceptive pills
Key points for providers & clients yy Requires keeping a flexible ring in the vagina. It is kept in place all the time, every day and night for three weeks, followed by a week with no ring in place. yy Start each new ring on time for greatest effectiveness.
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yy Bleeding changes are common but not harmful. Typically irregular bleeding for the first few months and then lighter a more regular bleeding.
Advantages of Vaginal Ring yy Return of fertility after ring use is stopped: No delay yy Protection against sexually transmitted infections: None
Disadvantages of Vaginal Ring yy Vaginal Rings don’t protect against HIV infection or STIs such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphillis
Side Effects of Vaginal Ring Some users report the following: yy Changes in monthly bleeding, including: »»
Lighter bleeding and fewer days of bleeding
»»
Irregular bleeding
»»
Infrequent bleeding
»»
Prolonged bleeding
»»
No monthly bleeding
yy Headaches, dizziness yy Irritation, redness, orinflammation of the vagina (vaginitis) yy White vaginal discharge yy Weight gain yy Vomiting
Contraindications All the contraindications for hormonal contraceptives are also to be considered.
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Frequently asked questions 1. Can a Vaginal Ring get lost inside of me?
No. A Vaginal Ring cannot be pushed too far up or get lost in your body. In fact,it cannot go farther than the cervix.
2. Will a Vaginal Ring dissolve?
No. A Vaginal Ring does not dissolve. It releases a low dose of hormones into your body over the course of three weeks. After that time, you need to remove it, take a week off from vaginal ring and insert a new one seven days after removal
3. Is a Vaginal Ring like a diaphragm?
No. it is not a barrier method. Just like the pill, it is a contraceptive that contains hormones for preventing pregnancy.
4. What should one do if the Vaginal Ring is in it for too long?
If a Vaginal Ring has been left in for more than three weeks (but less than 4 weeks), remove it immediately and insert a new ring after a one-week ring-free break.
If it has been left in place for more than four weeks, you may not be adequately protected from pregnancy and must check to be sure you are not pregnant. If you are not pregnant, insert a new vaginal ring. You must use an extra method of birth control (such as condoms or spermicide) until you have used the new vaginal ring for seven days in a row. If you know or suspect you may be pregnant, do not use vaginal ring. See your doctor as soon as possible.
5. Can there be an overdose when using the Vaginal Ring?
The Vaginal Ring is unlikely to cause an overdose because the ring holding the medicine releases a steady amount of contraceptive hormones. Do not use more than one ring at a time. Overdose of combination hormonal contraceptives may cause nausea, vomiting, or vaginal bleeding.
6. How should I store the Vaginal Ring?
After being dispensed by the pharmacy, a Vaginal Ring can be stored for up to four months at room temperature (25째C). Temperatures can be from (15째 to 30째C). Avoid direct sunlight or storing above (30째C).
7. Can a woman use vaginal medications when using a Vaginal Ring?
Use of spermicides or vaginal yeast products will not reduce the contraceptive efficacy of a Vaginal Ring.
8. What happens when the Ring disconnects?
There have been reported cases of Vaginal Ring disconnecting at the weld joint causing the ring to change shape and straighten out. This is not expected to affect the contraceptive effectiveness of a Vaginal Ring. If the Vaginal Ring disconnects, expulsion (slipping out) is more likely to occur. If you discover the ring has disconnected, you should discard the ring and replace it with a new ring.
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Chapter 4
Irreversible Methods Male Sterilization Female Sterilization
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4.1. Male Sterilization Male Sterilization Vasectomy, a method of male sterilization, is a simple, minor surgical procedure that is performed by entering the scrotum through a small incision or puncture, locating each vas deferens, and cutting /blocking each of the vas to prevent sperm from passing. It usually takes 5-15 minutes to perform, after 5-10 minutes for preoperative preparation and administration of local anaesthesia. It is also called male sterilization or male surgical contraception.
Mechanism of Action It works through closing of vas deference on either side. This keeps sperms out of his semen. The man can still have erections and ejaculate semen. His semen, however, no longer makes a woman pregnant because it has no sperm in it.
Effectiveness This is one of the most effective and permanent methods but carries a small risk of failure as commonly used—0.15 pregnancies per 100 men in the first year after the procedure. The risk of failure is greater if men get their semen examined within three months of the procedure as vasectomies are not effective till three months after the procedure. Correct use means using condoms or another effective family planning method consistently for at least for first three months or till the sperm completely disappears from the semen. If a partner of man becomes pregnant this may be because – yy Couple did not use any other method for three months after vasectomy yy The provider made a mistake yy Cut ends of vas regenerated The procedure is intended to be permanent. A reversal of this surgery is possible but it involves major surgery, is expensive difficult and may not be available and its success cannot be guaranteed.
Advantages yy Nothing to remember except to use condoms or another family planning method for at least the first three months or till the sperm completely disappears from semen. yy No interference with sex. Does not affect the man’s ability to have sex. yy Increased sexual enjoyment because no need to worry about pregnancy. yy No supplies to get, no repeated clinic visits required. yy No apparent long term health risks. 86
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yy Compared with voluntary female sterilization, vasectomy is: »»
Probably slightly more effective
»»
Slightly safer
»»
Easier to perform. Less invasive
»»
If there is a charge, often less expensive
»»
Able to be tested for effectiveness at any time.
»»
If pregnancy occurs in the man’s partner, less likely to be ectopic than a pregnancy in a woman who has been sterilized.
Complications yy Common intra-operative complications: »»
Transient drop in BP or dizziness due to vaso-vagal attack. In such cases procedure should be delayed and client allowed rest. An intravenous injection of atropine (0.6 mg) be given if there is bradycardia. Oxygen should be administered simultaneously.
»»
Convulsion and reactions to local anaesthesia. Maintain patency of airways and give 100 percent oxygen. If convulsion persists injection diazepam (5-10mg) IV can be given. Surgery should be stopped and client allowed to recover.
»»
Injury to testicular artery. This is rare, but if it occurs, pressure should be used to tamponade both ends of the vessel. Subsequently both ends of artery should be ligated.
yy Immediate complications of surgery: »»
Minor complications such as swelling of scrotal tissue, bruising and pain. These often disappear without any treatment. Ice packs, scrotal support and simple analgesics may provide relief.
»»
Hematoma. If this is small treat by scrotal support, analgesics and antibiotics. A large hematoma may need evacuation and further treatment. If hematoma is detected remove clots, look for bleeding and oozing points which should be tied. Referral should be considered.
yy There can be stitch abscess, wound sepsis and orchitis. These conditions should be treated with antibiotics, local dressing and analgesics. yy Delayed complications: There can be sperm granuloma at either side of vas occlusion. Majorities are symptomless and easily respond to analgesics and anti-inflammatory drugs. There is no association of prostatic or testicular and cardiovascular diseases with vasectomy.
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Medical Eligibility Most men can have vasectomy. Most men who want vasectomy can have safe and effective procedures in routine settings. This includes men of any age, who have no children, who have sickle cell disease or hereditary anaemia; or who are HIV positive or at high risk of HIV or other STIs (However, vasectomy does not prevent a man from passing HIV or other STIs to others). If he has the following, DELAY vasectomy and refer for treatment: yy Active sexually transmitted infection. yy Inflamed (swollen and tender) tip of penis, ducts or testicles. yy Scrotal skin infection or mass in the scrotum. yy Acute systemic infection or significant gastroenteritis. yy Filariasis or elephantiasis. If he has any of the following, REFER him to a centre with experienced staff and equipment that can handle potential problems: yy Hernia in the groin (provider if able, can perform vasectomy at the same time as repairing hernia. If this is not possible, the hernia should be repaired first). yy Undescended testicles- both sides. yy Current-AIDS related illness. yy Coagulation disorders. If he has any of the following, use CAUTION: (means this can be done in routine settings but extra precautions are needed): yy Previous scrotal surgery or injury. yy Large varicocoel or hydrocoele (swollen veins or membranes in the spermatic cord or testes, causing swollen scrotum). yy Undescended testicles –one side only (vasectomy is performed on the normal side only. Then if any sperm remains in the semen after three months, the other side must be done, too). yy If he has diabetes. IMPORTANT: A man considering vasectomy needs good counseling.
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Counseling Since a vasectomy is intended to be a permanent method of contraception, it should be provided only to men who have decided on their own that they do not want children any more. Clients should be counseled about other available methods of contraception before deciding on sterilization. Counseling should also include sharing information on the simplicity of the procedure and how a man can also be responsible partner in matters of reproduction and contraception.
Client assessment Vasectomy is a safe and simple procedure when undertaken with proper screening. Prior to vasectomy, a medical history should be taken and a limited physical examination should be done including genital examination; the penis, scrotum, and inguinal region should be inspected visually; and the scrotum should be palpated. Laboratory tests should not be routine but should be reserved for specific cases in which the provider suspects a condition that would make it necessary to take extra preparation or preparation.
Informed consent The surgeon should verify that the client has signed the informed consent form before beginning the procedure. Although the purpose of signing the form is to document informed consent, the principal focus should be on confirming that the client has made an informed choice for a vasectomy as a contraceptive method.
Infection prevention Strict adherence to infection prevention practices all the times (before, during and after) is also crucial to the safety of the procedure. Proper aseptic technique is essential to prevent both immediate and long-term infectious morbidity and mortality. Inadequate infection prevention practices can lead to surgical site infections, tetanus and infections such as HIV and hepatitis B, hepatitis C. Shaving of the scrotum is no longer recommended, as this significantly increases colonization of micro-organisms increasing the chance of surgical-site infection.
Anaesthesia Good anaesthesia is essential for a pain-free vasectomy. The purpose of anaesthesia is to ensure that the client is free from pain and discomfort during the operation. Both conventional and no scalpel vasectomy are done under local anaesthesia. Premedication is commonly not required. Use of regional or general anaesthesia is rarely needed and increases the risk and costs of the procedure. However, general anaesthesia may be necessary when there are scrotal abnormalities (such as large varicocele, large Hydrocoele or Chryptorchidism) or when vasectomy is performed along with another surgical procedure. Men who need modest sedation (e.g. those who are extremely nervous) may be given a small dose of an oral tranquilizer, such as diazepam. 89
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Instructions to client Men undergoing vasectomy should receive clear instructions about post-operative care, anticipated side effects, actions to be taken if complications occur, sites where they can access emergency care, the need for post-operative semen analysis, use of condoms and the time and place for making a follow-up visit.
Requirements for a Safe Procedure Essential elements of quality sterilization include counseling, client assessment and screening, informed consent, infection prevention, selection of appropriate procedures, safe anaesthesia regimens and post-operative care and instructions.
Providing Vasectomy Learning to perform vasectomy takes training and practice under direct supervision. Therefore, this description is a summary and not detailed instruction. All family planning providers should understand these procedures and be able to discuss with clients, both men and women.
The vasectomy procedure yy The provider uses proper infection prevention procedures at all times. yy The man receives injection of local anaesthetic in his scrotum to prevent pain. He stays awake throughout the procedure. yy The health care provider feels the skin of the scrotum to find each tube (vas deferens). The provider makes a small incision in the skin with a scalpel or else uses a special instrument to make a puncture (the no-scalpel technique). yy The provider lifts each vas out of the incision. Most providers cut each vas and tie one or both ends closed with thread. Some close off the vas with heat or clip. The incision may be sewn shut or just covered with an adhesive bandage. The procedure is over. Some providers also use facial transposition for better results. With fascial transposition, the fascial sheath (the thin layer that surrounds the vas) is sutured over one end of the cut vas. Fascial interposition places a tissue between two cut ends of vas. Ligation without division is not recommended, as the potential for failure due to recanalization is more. Division with facial interposition increases effectivity. yy After the procedure the client should rest for 15-30 minutes. yy The man receives instructions on how to care for the wound. If his wife is not using an effective contraceptive, he receives and uses condoms until sperm is cleared from his system. They should wait three months till the semen shows no sperm before relying on his vasectomy for contraception. During this period, the man should resume sexual activity, but he or his partner will need to use additional contraceptive protection. Semen analysis, where available, can confirm contraceptive effectiveness after the three–month waiting period. 90
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yy He leaves the clinic within a few hours, often in less than one hour. Preliminary results from randomized controlled trials found that use of fascial interposition with ligation and excision of vas during vasectomy lead to more rapid decrease in sperm count than when ligation and excision were used alone.
Explaining Self-care Before the procedure, the man should: yy Bathe thoroughly, especially genital area and upper inner thighs. yy Wear clean and loose fitting clothing to the health facility. yy Not take any medicines for 24 hours prior to the procedure, unless heath care provider performing the procedure tells him to do so.
After the procedure, the man should: yy Rest for two days. He should not do any heavy work or vigorous exercise for a few days. yy Keep the incision clean and dry for two to three days. He can use a towel to wipe his body clean but should not soak in water. yy Wear snug underwear or pants for two to three days to help support the scrotum. This will lessen swelling, bleeding and pain. yy Take Paracetamol or another safe, locally available pain-relief medication as needed. He should not take aspirin or ibuprofen, which slow blood clotting. yy Use condoms or another effective family planning method for three months or more after the procedure till azoospermia is achieved—Client can have sex within two to three days after the procedure if it is not uncomfortable but needs to use condoms. He can expect his sexual performance to be unchanged. Vasectomy does not affect man’s ability to have sex. In most cases, using good surgical technique to minimize the trauma and limit bleeding, practicing aseptic techniques, and giving clients good post-operative instructions can prevent bleeding, hematoma, and infection Explain specific reasons to see a doctor or health care provider A man who has undergone vasectomy should return to the clinic for any of these reasons: For a follow-up, as per the national guidelines for vasectomy: yy All clients who undergo vasectomy should be visited by a health worker within 48 hours. In non-scalpel vasectomy (NSV) cases, the client should also be seen 48 hours after operation. yy First follow-up: seven days after the surgery, the client should go for removal of stitches (in cases of incisional vasectomy), to have the wound examined and to have his questions answered if any. 91
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yy Second follow-up: the client should undergo semen analysis after three months. yy Emergency follow-up: this can be done at any time after the surgery. »»
His wife misses her menstrual period or thinks she is pregnant.
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He has questions or problems of any kind.
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Return at once, if he has: −− High fever (greater than 380C) in the first four weeks and especially in the first week, or −− Bleeding or pus from the wound, or −− Pain, heat, swelling, or redness at an incision that becomes worse or does not stop (signs of infection)
If the clinic cannot be reached quickly, he should go to another doctor or health care provider at once.
Helping client at any routine return visit IMPORTANT: Follow-up within seven days or at least within two weeks is strongly recommended. A heath care provider checks the site for any signs of complications, and removes stitches in incisional vasectomy. This can be done in the clinic, in the client’s home (by a trained provider), or at any other health centre. No man should be denied a vasectomy because follow up would not be possible. A man may want to come back to have his semen examined, if feasible, at least three months after vasectomy. This microscopic examination can make sure his semen contains no sperm, or his vasectomy is working.
Ask questions At any routine visit yy Ask if the client has any questions or anything to discuss. yy Ask the client about his experience with vasectomy, whether he is satisfied, whether he has any problems. Give him any information or help that he needs, and invite him to return any time he has questions or problems. Problem
Provide treatment
Pain
Check for blood clots in the scrotum. yy Small, uninfected blood clots require rest and pain-relief medication such as Paracetamol yy Large blood clots may need to be surgically drained yy Infected blood clots require antibiotics and hospitalization
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Problem Infection (Pus, heat, pain or redness caused by bacteria or other germs) Abscess
Provide treatment yy Clean site with soap and water or antiseptic yy Give 7 to 10 day course of antibiotics yy Clean site with antiseptic yy Incise and drain abscess yy Perform wound care
Fear of impotence
yy If significant skin infection involved, give 7 to 10 day course of antibiotics In counseling before the procedure, the health care provider should assure the client that vasectomy does not physically change sexual desire, functioning, or pleasure. This information can be repeated at any follow up visits.
Managing any problems During recovery and healing, if a man experiences strong pain, heat, swelling or redness at or around the incision, he should come back to the clinic. If this happens, a health care provider should check for clots, pus, infection or abscess.
Certificate of Sterilization A certificate of sterilization should be issued only after the semen analysis shows no sperm. yy Tell client that he should report to the clinic for semen analysis after three months. yy If sperm is still present in semen after three months then client is tested every month till six months. yy Do not declare failure of vasectomy till six months. yy If sperm is still present after six months consider re-vasectomy
Frequently asked questions on Vasectomy 1. Will vasectomy make a man lose his sexual ability, make him weak or fat?
No. After vasectomy, the male sexual physiology remains unaffected (aside from the desired change in fertility). The nerves involved in erection are not involved during the vasectomy procedure. Seminal fluid continues to be produced and the tubes that carry seminal fluids remain intact. The male sex drive, ability to have an erection and ejaculation of semen will be unaffected by a vasectomy and will remain the same as before. Testicles will continue to create sperm.
After vasectomy, unused sperm cells will be absorbed into the body instead of leaving in the semen. With sperm making up less than five percent of semen, there will be no noticeable differences in ejaculation.
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After vasectomy, the fluid volume, colour and texture of ejaculation remain the same. The person can work as hard as before. He will not gain weight because of the vasectomy.
For some couples, the ability to have sex without worrying about conception can even improve their sex life
2. Does a man need to use another contraceptive method after vasectomy?
Vasectomy does not immediately work. After a vasectomy, the male will still have active sperm in his semen for about three months or more. Not using another method for the first three months is the main cause of pregnancies among couples relying on vasectomy. Over the next few months the semen will be tested to ensure there is no active sperm and that the vasectomy is complete.
Besides that, vasectomy does not protect against STIs, including HIV. All men at risk of STIs, including HIV, whether or not they have had vasectomies, need to use condoms to protect themselves and their partners from infection.
3. Is it possible to check if a vasectomy is working?
Yes. A provider can examine a semen sample under a microscope to see if it still contains sperm. If the provider sees no moving (motile) sperm, the vasectomy is working. A semen examination is recommended at any time after three months following the procedure. If there is less than one non-motile sperm per 10 high-power fields (less than 100,000 sperm per milliliter) in the fresh semen sample, then the man can rely on his vasectomy and stop using a backup method for contraception. If his semen contains more moving sperm, the man should continue to use a backup method and return to the clinic monthly for a semen analysis. If his semen continues to have moving sperm, he may need to have a repeat vasectomy.
4. What if a man’s partner gets pregnant after vasectomy?
Every man having a vasectomy should know that vasectomies sometimes fail and his partner could become pregnant. He should not make the assumption that his partner was unfaithful, if she becomes pregnant. Remind the man that for about three months, they needed to use another contraceptive method. It takes 20 or more ejaculations to empty the seminal vesicles. Semen analysis should be conducted and, if sperm is found, a repeat vasectomy is required.
Rarely failure occurs due to occlusion of a structure other than the vas deferens, reattachment of the cut vas deferens ends, and recanalization. The risk of early failure is about 1-2 per 1000 vasectomy procedures.
5. Will the vasectomy stop working after a time?
Generally not. Vasectomy is intended to be permanent. In rare cases recanalization may occur. The risk of this is about 1-4 per 5000 vasectomies. Recanalization occurs when the vas deferens ends are reconnected by sperm being pushed up through the healing tissue and forming many small channels which connect with the cut vas deferens upstream from the occlusion site.
6. Can a man have his vasectomy reversed, if he decides that he wants another child?
Vasectomy is intended to be permanent and men considering vasectomies should not think of them as reversible. Clients must be told that a reversal of this surgery is possible, but the reversal involves a major surgery and its success cannot be guaranteed. People who are not ready for a permanent method of sterilization, who may want more children, should choose a different family planning method. Surgery to reverse vasectomy is possible for only some men and reversal often does not guarantee a pregnancy. The reversal procedure is difficult and expensive, and there are very few providers who are able to perform such surgery. Vasectomy causes a breakdown in the blood-testes barrier that leads to increased levels of serum anti-sperm antibodies in most men. If a man has a vasectomy reversal, the presence of these antibodies can inhibit pregnancy, even if the vasa are successfully reconnected.
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7. Is it better for the man to have a vasectomy or for the woman to have female sterilization?
Each couple must decide for themselves which method is best for them. Both are very effective, safe, permanent methods for couples who know that they will not want more children. Ideally, a couple should consider both methods. If both are acceptable to the couple, vasectomy would be preferable because it is simpler, safer, easier, less invasive and less expensive than female sterilization.
8. Does vasectomy have long term health risk?
Over the years, there have been concerns about possible negative health consequences resulting from vasectomy. However, results of large, well-designed studies have consistently shown no adverse effects of vasectomy on the risks of heart disease, testicular or prostate cancer, immune system disorders, and a host of other conditions. Men requesting the procedure can thus be reassured that there is no substantial longterm health risk associated with the procedure.
9. Can a man who has a vasectomy transmit or become infected with sexually transmitted infections including HIV, HVB and HCV?
Yes. Vasectomy does not protect against STIs, including HIV, HVB and HCV. All men at risk of STIs, including HIV, HVB and HCV, whether or not they have vasectomies, need to use condoms correctly and consistently to protect themselves and their partners from STI infections.
10. Are there risks undergoing vasectomy?
As with any surgical procedure, there is a small risk of infection. Complications are unusual, but may occur in the form of inflammation or light bleeding and are typically treated with medication and rest.
11. How effective is a vasectomy?
A vasectomy is 99% effective.
12. How soon can person return to work after a vasectomy?
Most clients can return to work two to three days after the vasectomy surgery, if they feel comfortable. After the vasectomy procedure a person can continue doing household chores the same day. Strenuous work should be avoided for 48 hours. After 48 hours of the NSV procedure one he can resume strenuous work like lifting heavy bags, ploughing etc. if he feels comfortable. The acceptor should avoid cycling for one week (because testicles and vas rub against seat of the bicycle while pedaling).
13. When can one resume intercourse after the vasectomy?
After the vasectomy procedure, a client can have intercourse as soon as it is comfortable for him, which usually takes about two to three or more days. The client or his partner will need to use another method of contraception for three or more months following vasectomy, to avoid an unplanned pregnancy, as the man can still cause a pregnancy until the sperm count is zero. Clients should not have unprotected sex until the semen has been tested and a zero sperm count has been confirmed. Every client should be offered the opportunity to have a semen analysis. Ideally, one or two sperm-free semen specimens should be obtained from the client after vasectomy, to be reasonably sure that the vasectomy operation has been successful.
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4.2. Female Sterilization Female sterilization is the most widely used family planning method in the world and one of the most effective. Female sterilization is one of the options available to couples who have decided to end childbearing. Information and guidance about sterilization should be part of a broad discussion about family planning options. Female sterilization is an attractive option for many women because it is a single procedure that provides protection without the need for future involvement by the woman. Given the permanence of this option, however, it is essential that the decision to undergo sterilization is made thoughtfully and voluntarily, on the basis of complete information about the procedure, including its risks, benefits and alternatives.
Mechanism of Action Female sterilization is the surgical procedure used to end a woman’s ability to become pregnant. This procedure involves blocking (commonly referred to as occluding) the fallopian tubes (also called uterine tubes or oviducts) so that the egg and sperm cannot meet. This is done during a relatively simple operation, which varies according to: yy Surgical approach used to reach the tubes yy The technique used to block the tubes yy The timing of the procedure. The timing factor — whether or not the procedure will be performed just after a woman gives birth — influences the choice of both the surgical approach and the blocking technique. It will also have an important influence on the type of counselling issues that need to be discussed.
Effectiveness Women who choose sterilization benefit from highly effective protection from pregnancy. With less than one in 100 women getting pregnant after one year, female sterilization is one of the most effective contraceptive options available today.
Eligibility Criteria Female sterilization is suitable for most women who are certain that they want no more children and need a reliable contraceptive. From a medical perspective, the procedure is most appropriate for women who have no contraindications to surgery or anaesthesia. Women who have a current pelvic infection should not undergo the procedure until treated and fully recovered. When the procedure is to be done immediately after child delivery, it is best performed when there are no signs of infection or other complications associated with delivery
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Counselling Female sterilization should be presented as one of many options available to women interested in permanent contraception. Potential clients should receive complete information about all available family planning methods with no undue emphasis on sterilization. The health provider should carefully screen potential clients for sterilization to ensure that each has a desire to end childbearing and has a full understanding of the risks and benefits of the method. Various factors, especially the client’s age and the number of living children, may be warning signals that a client will become dissatisfied later with her decision. This regret appears to be more common among women with certain characteristics or situations, such as: yy Young age yy Few or no children yy Marital instability yy Partner who doesn’t agree with decision yy Uncertain about wanting more children These warning signs are useful for identifying women who may need special counselling but should not be used arbitrarily to deny the procedure to a woman who has made an informed and voluntary decision.
Timeline for Female Sterilization The sterilization procedure can be done at most times during a woman’s reproductive life. It is usually performed during: yy The immediate postpartum period, immediately following or up to 48 hours after a vaginal delivery, or during a caesarean section delivery. yy The post-abortion period, immediately following an induced or spontaneous abortion, or yy The interval period, when the woman has not recently been pregnant or at least six weeks since a woman’s last delivery (when the uterus has returned to its normal size). Female sterilization should not be performed when a women is pregnant or during days 8 to 41 after delivery. With special care, sterilizations can be performed during three to seven days after delivery (the postpartum period).
Common Surgical Approaches or Procedures Two common approaches, both through the abdomen, are used to reach the fallopian tubes: yy Mini-laparotomy involves a small abdominal incision through which a surgeon usually lifts the fallopian tubes out of the abdomen to block them. The incision is 2-5 cm above the pubic hairline when a woman has not recently been pregnant or 1.5-3 cm just below the navel or umbilicus for postpartum procedures. This procedure is appropriate for women during interval, post-abortion and immediate postpartum periods. During interval mini-laparotomy, the 97
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provider may use a uterine elevator, a metal instrument which is inserted into the vagina to raise the uterus. This makes it easier to move the pelvic structures so that the tubes are near the incision site. yy Laparoscopy uses a laparoscope, a narrow lighted tube through which a surgeon is able to see into the abdominal cavity and pelvic structure. This optical instrument is inserted through a small puncture near the navel, or umbilicus. The same opening, or sometimes a second puncture, is used to manipulate the organs and block the tubes. It is recommended only for women in the interval period or following first-trimester abortion (when gestation is less than 12 weeks). Laparoscopy should not be performed on women during the postpartum period because of the orientation and the vascular nature of the postpartum uterus. Table 1: Comparison of mini-laparotomy and laparoscopy for female sterilization Mini-laparotomy
Laparoscopy
Instruments and equipment
Requires a few inexpensive, standard surgical instruments.
Requires sophisticated and expensive endoscopic equipment that is difficult to maintain.
Surgical skills and expertise
Can be performed by health workers with basic surgical ability and skills, after training in the technique. Suitable for postpartum, postabortion and interval periods.
Restricted to specially trained surgeons, usually obstetricians and gynaecologists. Requires regular practice to maintain skills.
Setting
May be performed in maternity centres and basic health facilities with surgical capacity.
Fully equipped operating room and anaesthetist required.
Time necessary for the operation
Depending on the experience of the operator, takes on average 10-20 minutes.
Depending on the experience of the operator, takes on average 5 -15 minutes and so most appropriate for services with large daily case-loads.
Precautions
Difficult to use for obese women (especially for interval procedures) and those with pelvic scarring and adhesions. Complications are rare. Slight risk of bowel and bladder injuries, uterine perforation and wound infection. Recommended local anaesthesia.
Not recommended for postpartum women or for women with previous lower abdominal surgery or pelvic infections.
Side-effects
Short-term abdominal pain may occur.
Postoperative chest and shoulder pain resulting from abdominal insufflation may occur.
Effectiveness
Highly effective; failure rates less than 1% after 12 months.
Highly effective; failure rates less than 1% after 12 months.
Timing
Complications
Anaesthesia
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Most suitable for interval period and following first trimester abortion.
Complications are rare. Slight risk of vascular injury, bowel injury and insufflation accidents. Some complications may require use of general anaesthesia. Local, spinal or general anaesthesia.
Reference Manual for Doctors on Family Planning and Reproductive Health
Frequently asked questions on Female Sterilization How does timing affect choice of surgical approach? Mini-laparotomy can be used to reach the tubes at any time (during the interval, post-abortion or postpartum periods), whereas laparoscopy should only be performed during the interval period or following an early induced (first-trimester) abortion. Laparoscopy is not otherwise recommended for use postpartum because of the possibility of injury to the large, vascular uterus of postpartum women.
What are the common techniques for blocking the fallopian tubes? The choice of the blocking method depends upon several factors, including type of surgical approach (mini-laparotomy or laparoscopy), the timing of the sterilization (postpartum or interval), provider’s training, and availability of supplies. Once the provider reaches the uterine tubes, the tubes can be blocked) by two commonly used methods: yy Ligation and division (cut and section). Ligation is used only with mini-laparotomy (both postpartum and interval cases), this method involves tying each fallopian tube with suture material and then cutting and removing a section. The most common method is the Pomeroy technique, in which a segment of the fallopian tube is tied in a loop and then the top portion of the loop is cut and removed. Another method — the Parkland technique — involves tying the tube at two points and removing the intervening segment. yy Mechanical devices. The preferred choice for use with laparoscopy, this involves placing a device (hinged or spring clips or a small ring or band made of silicone rubber), to close and seal each tube. The various mechanical methods, which are suitable for interval cases using laparoscopy, require a specialist surgeon trained in laparoscopy. The rates of failure and complications may increase if training is inadequate or skills not maintained by routine practice of the procedure. yy Electrical methods. Electrocoagulation is used with a laparoscope to burn and block the tubes. This method is no longer recommended because research shows a greater risk for internal burns during the procedure and for ectopic pregnancy after the operation.
How does the surgical approach and the timing factor affect choice of the blocking technique? The timing of the procedure, whether a woman wants to have the procedure immediately after delivery or not, influences the choice of both the surgical approach and the blocking method. During the interval period (when a woman has not recently been pregnant or it has been at least six weeks since delivery), either surgical approach (mini-laparotomy or laparoscopy) can be used along with either blocking method (ligation or a mechanical device). For immediate postpartum sterilization, mini-laparotomy is the recommended surgical approach, with ligation, using clips, rings or bands. During caesarean surgery, ligation is the most common method. For post-abortion sterilization, both surgical approaches and blocking methods may be used (although the mechanical devices require extra care because of the somewhat enlarged tubes).
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What are the health benefits of female sterilization? Given the considerable health risks associated with unspaced pregnancies, the use of contraceptives provides a significant health benefit to women at risk of unwanted pregnancy. Also in contrast to temporary methods, it does not require continuous involvement by the woman. A woman who has undergone sterilization is spared the common worries linked to temporary methods — partner compliance, inconvenience, side effects, supply problems, and the consequences of forgetfulness. In addition to its benefit as a contraceptive, recent research suggests that sterilization may reduce a woman’s risk of ovarian cancer.
What are the possible complications of female sterilization? Short-term. Complications are rare. The types of complications vary by the type of surgical procedure. Mini-laparotomy complications include wound infection, uterine perforation with uterine elevator, and bladder or intestinal injury. Laparoscopy complications may involve anaesthesia problems, tears and transections of the tubes, and injuries to organs from instruments such as the uterine elevator, insufflation needle or trocar. Although the complications with laparoscopy are not more common than with mini-laparotomy, some are more severe and require general anaesthesia. The rate of complications is highly dependent on the level of surgical skill and experience. The chance of having these problems is largely limited to the time of surgery or shortly thereafter. Most of these problems can be prevented with attention to careful screening, use of local anaesthesia with light sedation, careful surgical technique, good asepsis, and appropriate post-operative care. The seriousness of these problems can be minimized if they are recognized early and treated promptly. Oral and written post-operative instructions (with illustrations where needed for low and non-literate women) should direct women to return to the clinic one week after the procedure to ensure that no infection has occurred. Long-term. Failure of sterilization is rare. However, when pregnancy occurs in a woman who has undergone sterilization, it is likely to be an ectopic (tubal) pregnancy, which is potentially fatal. Women should be counselled about the importance of getting medical attention immediately if they believe that they might be pregnant. Subsequent regret about the sterilization decision is another possible consequence. Research results underscore the importance of counselling women considering sterilization about the permanent nature of sterilization and the possibility of regret.
What are the considerations regarding immediate postpartum sterilization? The period immediately after childbirth is a popular time for women to undergo sterilization by mini-laparotomy. It offers advantages from both the mother’s and provider’s perspective. It is often less painful and recovery time is shorter than with interval mini-laparotomy. It is convenient for the mother because it eliminates the need for a separate visit for the sterilization procedure and having the procedure done immediately postpartum does not prolong the normal hospital or maternity stay.
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From the provider’s viewpoint, a smaller incision is possible because of the enlarged postpartum uterus, and it is easier to reach the fallopian tubes. With less extensive abdominal manipulation, less instrumentation is necessary. The engorged fallopian tubes in postpartum women can be more difficult to block, however, so that mechanical devices such as rings and clips are usually not suitable. One device, the Filshie Clip, is an exception. Immediate postpartum sterilization may have some advantages, but the chance that a woman will regret her previous decision after undergoing sterilization is higher with women who undergo the procedure at this time, especially in cases of a child’s illness or death or a change in marital status. Proper counselling is very important. As pregnancy and childbirth may influence a woman’s decision to have no more children, it is critical that counsellors encourage careful thought about the decision. The choice should be made well in advance of delivery or abortion and never when postpartum and abortion clients are sedated or in labour. Stress, pain and sedatives may influence a decision that later will be the wrong choice. Research suggests that regret after postpartum sterilization may be more common among younger women (less than 30 to 35 years old), women with few children, and those having caesarean sections. For postpartum clients with medical problems or for those who do not wish a permanent method, other long-term options exist. The IUD and Norplant may be inserted during the immediate postpartum. Women who have a caesarean delivery may choose to undergo sterilization during the same procedure. Furthermore, sterilization should be performed at the time of caesarean section only with the woman’s full consideration and informed decision well before the procedure.
Where can sterilization be performed? In the case of mini-laparotomy, the procedure can be performed in maternity centres and basic health facilities with surgical capacity, including both permanent and temporary facilities with access to referral care. Laparoscopy requires a fully-equipped hospital, where laparoscopy is performed on a regular basis and an anaesthetist is available.
Who can perform the procedure? Only empaneled providers as per GOI guidelines can perform. As per these guidelines a post graduate qualification obstetrics/gynaecology is necessary for laparoscopic sterilization.
How do health workers help couples with decision-making? The purpose of family planning counselling is to assist couples with information and guidance about selection of a family planning method. In addition to providing complete and accurate information about methods of contraception (filling in gaps in the client’s knowledge and correcting misconceptions), a counsellor focuses on how these choices relate to a woman’s specific needs and circumstances. Couples wishing to maintain the option of having children should be counselled not to undergo sterilization. A woman’s right to make an informed and free choice is compromised when strong emphasis is placed on particular methods of contraception. Women should feel no pressure to choose sterilization.
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Counselling is particularly important in the case of sterilization because the procedure is permanent and it requires surgery. A counselling session with a woman considering sterilization should focus on the client’s needs and desires. Whenever possible, a woman should be encouraged to include her partner in the counselling process. However, except where it is a legal requirement, partner consent should not be mandatory.
The counselling session should yy Discuss the range of options. Information about sterilization must be part of a general discussion about family planning and the range of available choices. No strong emphasis should be placed on any particular method, such as sterilization. yy Clarify misconceptions. Attention should be given to identifying and counteracting rumours and myths about female sterilization and other methods of contraception. Research suggests misconceptions are a major obstacle to contraceptive use in some countries. Common misinformation about sterilization — for example, that sterilization will make a woman stop menstruating or affect her sexuality — can discourage a woman from choosing the method and should be addressed. It is generally agreed that sterilization does not affect female hormones and that it does not change sexual desire or satisfaction. yy Emphasize the permanence of sterilization. Family planning providers should emphasize the permanence of sterilization and the availability of alternative reversible methods. Providers involved in counselling should be trained to identify clients who are likely to change their mind about sterilization after the procedure has been performed. Younger women are at greatest risk of later regretting their decision. Age and other factors linked to heightened risk of future regret should be seen as warning signs but should not be used to deny the procedure to women who make a carefully considered decision. yy Discuss the sterilization procedure. Clients need to know the benefits and risks of surgical sterilization, including the rare but possible serious complications and the consequence of failure. They need to know what they can expect during and after surgery.
Counsellors should encourage a sufficient time interval between counselling and the procedure, and emphasize that clients are free to change their mind at any time before the procedure.
What is informed consent? After counselling and careful consideration, a woman may decide that sterilization is the right choice for her. She will be asked to sign an informed consent form indicating that she has made an informed and free choice. However, the informed consent form should not be dismissed as merely a legal requirement or a protection of the provider. A signed form does not guarantee that a decision was made freely or based on clear, complete and accurate information, but it can provide useful guidelines for family planning programmes offering sterilization services. After careful screening and
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counselling, the form can serve as a final step in the informed consent process. It provides a reminder to both provider and client and helps to ensure that a client: yy Knows that this is a surgical procedure and it is intended to permanently prevent the client from having more children. yy Has been informed about alternative family planning methods. yy Is aware of the benefits and risks of the procedure. yy Has made a voluntary choice. yy Knows that she may change her mind at any time before surgery without loss of medical or financial benefits.
What are the common restrictions on obtaining sterilization? Regulations regarding sterilization vary, but most of them are designed to protect the client from coercion and to minimize the incidence of regret by women after sterilization. Some countries require a minimum age (usually varying between 30 and 35 years) and insist women already have a minimum number of children, sometimes specifying the sex. Many countries require women to wait for a specified period of time between making the decision to undergo sterilization and the procedure. Consent of the spouse or partner may be required, although it is generally recognized that the focus should be on counselling and not consent of the partner or spouse.
What pre-operative care is required? Medical histories and physical examinations should include information regarding possible pregnancy, pelvic disease, previous abdominal surgery and other conditions that may increase a woman’s risks.
What do women need to know before the surgery? A woman who has decided to undergo sterilization must be advised to use temporary contraceptives until the procedure has been performed. A counselling session before the surgery should provide instructions on how to prepare for surgery and what to expect during and after the operation. Simple, non-technical explanation of the surgical steps and the anaesthesia to be used will inform and reassure the client. Sample client instructions for both pre-operative and post-operative care should include simple and clear illustrations for use with low and non-literate populations.
What follow-up care and information is necessary? Most women can be discharged on the same day following mini-laparotomy and laparoscopy, since recovery problems are minor and most complications are recognized either during or shortly after surgery. At that time, providers should again give women instructions on what to do after the surgery, including how to care for the wound and how to treat any pain that might occur, and what to expect (for instance, a small but visible scar will remain). Women should be advised to seek medical attention immediately if they experience any increase in abdominal pain.
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A follow-up visit should occur within seven days of surgery. A woman who has undergone sterilization during the interval period can expect to return to normal activities within three to five days and sexual relations within a week or when she feels comfortable thereafter. For women who undergo the procedure immediately after delivery, the procedure does not extend the normal recovery period for childbirth. A woman who has undergone sterilization has a less than one percent chance of becoming pregnant. However, providers and clients alike need to be aware of the possible consequences of pregnancy after sterilization. Among those women who do become pregnant after sterilization, there is a marked increase in risk of ectopic (tubal) pregnancy, which is potentially fatal. Women must be advised to watch for these signs of tubal pregnancy: lower abdominal pain, missed periods, and abnormal uterine bleeding. Despite careful screening, some clients may experience difficulty in adjusting to being sterilized, especially in the event of remarriage or loss of a child. For these women, counselling and support should be offered and appropriate information on centres of excellence where reversal services are available.
Is reversal possible? Most women who choose sterilization feel that they have made the right choice, but some women later regret their decision. For some of these women, surgery to restore fertility may be an option. Although reversal is sometimes possible, sterilization should never be considered a reversible procedure. Women considering sterilization must be counselled about the intended permanence and the possibility of future regret. Women should know that surgery to attempt to reverse sterilization is available only in some countries. Counselling should emphasize the following: yy Sterilization is intended to be permanent. yy Reversal procedure involves complex and lengthy surgery, highly trained surgeons and specialized equipment. It also often requires general anaesthesia. Risks are greater and recovery time is longer than for sterilization. yy A large number of reversal procedures are unsuccessful. yy Reversal surgery increases the chance that a woman will have a tubal pregnancy.
What other advice about sterilization should health workers give? Female sterilization and breast feeding. The procedure does not interfere with a mother’s milk production or adversely affect the health of the child. Female sterilization and sexually transmitted diseases. Women who undergo sterilization do not have any protection against sexually transmitted diseases (STDs), including HIV. Even if not at any risk of pregnancy, women who may be at risk of STDs must be counselled to use protection. For these women, condoms used correctly and at every intercourse is the best available protection. Other barrier methods (diaphragm, cap, sponge, and vaginal spermicides) provide limited protection.
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Chapter 5
Natural Family Planning Methods Standard Day Methods (SDM) Sympto-thermic Method Lactational Amenorrhoea Method (LAM)
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Natural methods for prevention of pregnancy are mainly of two types. These are Fertility Awareness Based Methods (FAM) and Lactational Amenorrhoea Method (LAM). Fertility Awareness Based Methods Fertility Awareness Based Methods of family planning help women identify their fertile window- the days of cycle in which they are most likely to get pregnant. If they wish to prevent pregnancy they need to avoid unprotected sex on these days.
Physiology of Menstruation Changes in the uterus, called The Menstrual Cycle. At the menarche, hypothalamic maturation leads to onset of cyclic ovulation that is release of ovum from ovary at periodic interval, while atresia continues. During each cycle, some 10-15 follicles enlarge to become secondary follicles, under the influence of FSH from the anterior pituitary. Fluid accumulation occurs in these follicles proceeds to the stage of Ovulation. After ovulation, capillaries from the theca interna invade the rapidly dividing granulosa layer and the clotted blood is replaced with yellowish, lipid rich luteal cells, forming the Corpus Luteum. This enlarges for 8-9 days during which the luteal cells secrete oestrogen and progesterone and: yy If fertilization has not occurred , the corpus Luteum regresses and eventually becomes Corpus Albicans yy If pregnancy occurs the Corpus Luteum continues to grow for several months and begins to degenerate at approx. the 6th month The time of Ovulation is the time of Maximum fertility, therefore, for pregnancy to occur, the coitus (intercourse) should take place within a day or two on either side of the Ovulation (fertile period). The rest of the menstrual Cycle constitutes a more or less Safe Period. There are commercial products available in the markets which help in determining the ovulation. Just prior to ovulation, Lutenizing Hormone is released. This kit detects release and helps determine and anticipate ovulation. A positive test is indicated by a test that is equal or greater intensity (darker) than the control band. A negative test result is indicated when the test band is lesser intensity (lighter) than the control band or cannot be seen. Users of FAM may not have unprotected sex whenever they wish, because for some days in each cycle they have to avoid sex or use a barrier method. Hence using FAB methods is amount to timing of sexual activity. Also generally couples perceive intercourse during menses as unhealthy, unclean and un-pleasurable. Fertility Awareness means that a woman learns how to tell when the fertile time of her menstrual cycle starts and ends. The following two methods qualify for inclusion in fertility awareness based methods:
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5.1. Standard Day Methods (SDM) Most women using the SDM use a device called Cycle Beads—a string of colour-coded beads that help women identify the days of their cycles when they can become pregnant and the days when pregnancy is very unlikely. The white beads, which represent the end of the cycle, indicate the time when the woman has a high probability of becoming pregnant if she has unprotected sexual intercourse. Mechanism of Action yy On the day that your menstrual period starts, hold the Cycle Beads and move the rubber ring onto the first red bead. yy Each day, move the rubber ring onto the next bead, moving in the direction of the arrow. yy Avoid sexual intercourse or unprotected sexual intercourse on the days when the rubber ring is on any of the white beads. SDM users who have two or more cycles outside the 26-32 day range, within any one year of use yy Advise her that the method may not be appropriate for her because of a higher risk of pregnancy. Help her consider another method. Initial provision of SDM for women whose menstrual cycles are within the 26-32 day range yy Provide another method of contraception for protection on days 8-19 if she desires. Give supplies in advance. SDM users who have unprotected intercourse between days 8-19 yy Consider the use of emergency contraception if appropriate Cyclebead Method
Image source: www.irh.org Institute for Reproductive Health, Georgetown University
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5.2. Sympto-thermic Method Symptom-thermic method The symptom-thermal method is a means of natural family planning that involves abstaining from sexual intercourse on days that a woman is fertile, or capable of getting pregnant.
Mechanism of Action To use the symptom-thermal method, a woman needs to learn about her body’s natural fertility signs and also take her temperature every morning. Daily temperature readings are performed using a basal thermometer, a special thermometer that will determine the body’s temperature within a few hundredths of a degree. This level of precision is necessary to detect the slight temperature increase that marks the end of the fertile period. The woman keeps a chart where she records her daily temperature and also other body signs that indicate when ovulation will occur. Other body signs include cervical mucus consistency, cervical position, mid-cycle cramping, and mood. To use this method, couples should receive training from a certified natural family planning instructor. Unlike the calendar-rhythm method or standard days method, a women can use this method no matter how long her cycles are. The couple avoids unprotected sex between the first day of monthly bleeding and either the fourth day after peak cervical secretions or the third full day after the rise in temperature (BBT), whichever happens later.
Effectiveness of symptom-thermal method Among experienced users, the symptom-thermal method has an overall annual failure rate of 13 to 20 percent. That means each year about one in seven users of this method experience a surprise pregnancy. For perfect users, the method has a failure rate of only two to three percent, but this method is completely ineffective if used incorrectly. For women who feel uncomfortable touching their bodies, this method can be used without recording information about cervical position or cervical mucus, but this will make the method less effective. Such women should consider the standard days method instead.
Side-effects and health risks of the symptom-thermal method Like other methods of natural family planning, there are no side effects or health risks because the user does not put anything into her body. There are no hormones, chemicals, or surgical procedures involved.
Advantages of FAM yy No chemical agents or physical devices. yy No side effects. yy Efficient when well taught and motivated. 108
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yy Low cost for methods based on observation. yy Not dependent on medical personnel after initial instruction. yy Promotes fertility awareness. yy Encourages shared responsibility and increases spousal communication as well as promotes male responsibility. yy Ethically acceptable . yy Can be used to plan or avoid pregnancy.
Limitations of FAM yy Takes time to learn 3-6 cycles. yy Some women find charting difficult. yy Requires commitment from both partners. yy More difficult at times of stress or hormonal change. yy No protection against STIs. yy Cannot be used without co-operation of partner.
Side Effects No known side effects
Managing any Problem Problems with use yy Problems with fertility awareness methods affect a woman’s satisfaction and the use of the method. If the client reports any problems, listen to her concern and give her advice. Help the client choose another method. Inability to abstain from sex during the fertile time yy Discuss the problem openly with the couple and help them feel at ease, not embarrassed. yy Discuss possible use of condoms, diaphragms, withdrawal or spermicides or sexual contact without vaginal sex during the fertile time. yy If she has had unprotected sex in the past five days, she can consider Emergency Contraceptive Pills. Difficulty in recognizing different types of secretions for the ovulation method yy Counsel the client and help her learn how to interpret cervical secretions. Suggest she can use the Two day Method, which does not require the user to tell the difference among types of secretions.
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Frequently asked Questions 1. Can only educated couples use FAM?
No couples with little or no formal schooling can do use FAM effectively. Couples must be highly motivated, well trained in their method and committed to avoiding unprotected sex during the fertile time.
2. Are Fertility Based Methods reliable?
For many couples, these methods provide reliable information about the fertile days. If the couple avoids vaginal sex or uses condoms or a diaphragm during the woman’s fertile time, FAM can be very effective. Using withdrawal or spermicides during the fertile time is less effective.
5.3. Lactational Amenorrhoea Method (LAM) What is Lactational Amennorhea Method? Lactational Amenorrhea Method (LAM) is the use of breast feeding as a temporary family planning method. LAM provides natural protection against pregnancy and encourages starting another method at the proper time.
Mechanism of Action LAM delays return of ovulation and menstruation in postpartum women. The most important factors controlling ovarian activity during lactation is the strength of sucking stimulus. It has been well established that duration of lactation amenorrhea and assumption of ovarian suppression is longer among fully breast feeding mothers than partially breast feeding mothers. The mothers with the highest sucking frequencies have higher prolactin levels, longest lactational amenorrhea and ovarian suppression. During lactation prolactin directly act on hypothalamus to prevent surge of lutenising hormone which stimulates ovulation.
Medical Eligibility for LAM Following conditions needs to be satisfied for successful LAM: yy The baby gets at least 85% of his or her feeding as breast milk. And the mother breast feeds often, both day and night. yy The mother’s menstrual periods have not returned. yy The baby is less than 6 months old. If any of these three is not true, the woman should use another method for effective family planning— one that does not interfere with breast feeding 110
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Also, women with following conditions can use LAM in any circumstances: yy Benign breast disease yy Breast cancer yy Headaches yy High blood pressure yy Varicose veins yy Vulvular heart disease yy Diabetes yy Iron deficiency anaemia yy Malaria yy Sickle cell disease yy Gallbladder disease yy Thyroid disease yy Uterine fibroid
Advantages of LAM yy Effectively prevents pregnancy for at least six months and may be longer if a woman keeps breast feeding often, day and night. yy Encourages the best breast feeding patterns. yy Can be used immediately after childbirth. yy No need to do anything at the time of sexual intercourse. yy No direct cost for family planning or for feeding the baby. yy No supplies or procedure required to prevent pregnancy. yy No hormonal side effects. yy Counselling on LAM encourages starting a follow on method at the proper time. yy Breast feeding practices required by LAM have other health benefits for mother and baby »»
Provides the healthiest food for baby
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Protects the baby from life-threatening diarrhoea
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Helps protect the baby from diseases like measles and pneumonia by passing mother’s immunities to baby
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Disadvantages of LAM yy Effectiveness after six months is not certain. yy Frequent breast feeding may be inconvenient or difficult for some women, especially working mothers. yy No protection against STIs including HIV. yy If the mother has HIV, there is a small chance that breast milk will pass HIV to the baby.
Contraindications for LAM There are no medical contraindications for LAM. All breast feeding women can use LAM, but women in the following circumstances may want to consider other contraceptive methods: yy Has HIV infection including AIDS. yy Is using certain medications during breast feeding (including mood altering drugs, reserpine, ergotamine, anti–metabolites, cyclosporine, high dose of Corticosteroids, Bromocriptine, radioactive drugs, Lithium and certain anticoagulants. yy Newborn has a condition that makes it difficult to breastfed (including being small-for-date or premature and needing intensive neonatal care, unable to digest food normally or having deformities of the mouth, jaw or palate.
Side Effects There are no known side effects for LAM
Managing any Problem yy Problems with breast feeding or LAM affect women’s satisfaction and use of the method. If the client reports any problem, listen to her concerns, give her advice and if appropriate, treat. yy Offer to help the client chose another method – now, if she wishes, or if problems cannot be overcome. yy HIV transmission through breast milk is more likely among mothers with advanced disease or who are newly infected. Women taking antiretroviral therapy during first weeks of breast feeding may reduce the risk of HIV transmission through breast milk. HIV women should be urged to use condoms with LAM.
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Frequently asked Questions 1. Can replacement feeding help reduce the risk of HIV?
Replacement feeding poses no risk of HIV transmission. If available replacement feeding is acceptable, feasible, affordable, sustainable and safe then exclusive breast feeding for the first six months is the safest way to feed the baby and it is compatible with LAM.
2. Can LAM be used for six months without worry that woman will run out of milk?
LAM can be used for six months without worry. Woman’s milk will be continued to be produced through six months and longer in response to the baby’s suckling or the mother’s expression of her milk.
3. Can LAM be used for fat or thin women?
LAM can be used by women with normal nutrition. No special foods are required. It can be used for a full six months without the need for supplementary foods. Mother’s milk alone can fully nourish a baby for the first six months of life.
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Termination of Pregnancy Medical Methods for Termination of Early Pregnancy Vacuum Aspiration
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Terminate of Pregnancy By a registered medical practitioner who possesses a recognized medical qualification as defined in the Indian Medical Council Act, 1956 whose name has been entered in a state medical register and who has such experience or training in Gynaecology and Obstetrics as prescribed by the MTP rules made under this Act. The rules further prescribe that only those persons having the following experience or training can perform MTP’s.
Up to 12 weeks gestation A practitioner who has assisted a registered medical practitioner in the performance of 25 cases of MTP of which at least five have been performed independently in a hospital establishment or maintained by the government or training institute approved for this purpose by the government.
Up to 20 weeks gestation yy A practitioner who hold a post graduate degree or diploma in Obstetrics and Gynaecology yy A practitioner who has completed six months of house surgery (residency) in Obstetrics and Gynaecology. yy A practitioner who has at least one year experience in the practice of Obstetrics and Gynaecology at any hospital that has all facilities.
Counselling Counselling is a structured interaction in which a person voluntarily receives emotional support and guidance from a trained person in an environment that is conducive to open sharing of thoughts, feelings and perceptions. Every woman who seeks MTP services must be counselled. Providers, nursing staff/ paramedical staff, counsellors (where available) may be appropriately trained to offer abortion related counselling services. Counselling is an integral part of safe abortion services and is important as performing the procedure correctly. Pre- procedure Counselling yy It helps the woman to decide about the termination of pregnancy. yy It ensures that the consent for the procedure is given after receiving the complete information about the procedure and understanding its implications. yy It helps the woman to adopt a contraceptive method after procedure. Following are the critical steps in pre-procedure counselling yy Ensure that privacy and confidentiality are maintained during counseling.
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yy Be non-judgemental while interacting with woman and be sensitive towards her needs. yy Establish a rapport with the woman and gain her confidence as abortion is a very sensitive issue and the woman may be reluctant to discuss it. Building rapport is also critical for finding out whether there have been any attempts to terminate the present pregnancy as this is important for predicting likely problems and may affect management. yy Make the woman feel comfortable mentally and physically. The former is extremely important as the woman may have strange feelings about terminating the pregnancy. yy Identify the reason for termination of pregnancy by asking relevant questions related to personal, social , family and medical history and past use of contraceptive methods. yy Use simple language and allow the woman to clarify doubts. yy If the woman is convinced about termination of pregnancy, assess the woman for the MTP procedure. yy If found eligible for MTP, explain the following in simple language »»
Range of available options of MTP procedures based on gestation
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Procedure chosen by her
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Likely risks associated with the procedure
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Care after the procedure
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Immediate risks associated with pregnancy (within 2-6 weeks) if no contraceptive method is used
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When to return to follow up
yy Involve the husband / accompanying person if the woman is comfortable. yy Help the woman sign the consent form. yy Discuss various contraceptive methods- mechanism, advantages and disadvantages. yy Help the woman to choose a contraceptive method and assess whether the method is appropriate (based on history and examination). If the chosen method is not appropriate, explain the reason and help her choose another method. If the method is appropriate, provide the method specific information. In case the method is not available at the centre, provide information and other assistance for getting the appropriate service elsewhere. If a woman is not willing to accept a contraceptive method: yy Do not refuse MTP, as the woman is likely to go elsewhere, probably to an illegal abortion provider and suffer complications. yy Assure the woman that she won’t be refused MTP. yy Wait for an opportunity to counsel her after the procedure. If she is still not willing to accept a contraceptive method, call her for follow up in a weeks’ time and counsel again. Encourage her to bring her spouse.
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yy Record the assessment findings, procedure, contraception or refusal to accept contraception and advice given (including referral). Post abortion counselling Important notes for counsellors on post - abortion contraception yy Roughly 75 percent women ovulate and six percent conceive within two to six weeks after abortion, if they are not using contraception. yy All modern contraceptive methods can be safely provided immediately after the first trimester MTP (caution to be taken for second trimester abortions). yy The continuation rate for postpartum abortion insertion of IUD is good. Insertion of IUD immediately after the first trimester MTP is not associated with higher risk of expulsion, infection or bleeding. yy Abdominal tubectomy can be safely performed concurrently with MTP. Laparoscopic ligation should be done after first trimester MTPs. Post abortion Counsellingis an integral part of the post-procedure care. It is as important as the pre abortion counselling because: yy It ensures that the woman has understood post-abortion care and what action to be taken in case of complications. yy It re-enforces the need for continuing the use of the contraceptive method chosen. yy It provides an opportunity to counsel for contraception in cases where the woman is not sure about accepting a contraceptive method. Important steps are: yy Ensure privacy and confidentiality and an empathetic attitude. yy Enquire from the woman how she is feeling and reassure in case of any problems. yy Repeat the information about post procedure care and ensure that the woman understands it fully. yy Repeat the potential effects / warning signs and what to do then. yy Call the woman for follow up in a weeks’ time and counsel again if the woman does not accept any form of contraception. Encourage her to bring her spouse.
Clinical Assessment Clinical assessment for eligibility to undergo termination of pregnancy is critical to avoid complications while providing services. It provides the following information: yy Confirmation of pregnancy yy Exact period of gestation
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yy Woman’s general health condition yy Associated gynaecological disorders and infection yy Associated medical problems Components of clinical assessment 1. History Taking
The following should be included:1.1 Personal details - Age, religion, address 1.2. Menstrual history: length and duration of cycle, flow (excess or normal), LMP 1.3. Obstetric history: Parity, live births, abortion (induced and spontaneous), previous caesarean section (if any), last child birth / abortion 1.4. History of any interference/ drugs taken in this pregnancy to attempt termination 1.5. Contraceptive history: type of contraceptive used, how long 1.6. Status of tetanus immunization: last dose received 1.7. Psychological assessment to assess family support 1.8. Sexual / domestic violence 1.9. Medical history should include the following: -
Hypertension
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Heart disease
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Renal disease
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Diabetes mellitus
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Epilepsy
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Asthma
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Drug allergies
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Bleeding disorders
2. Physical Examination 2.1. General Examination -
Check pulse, blood pressure and temperature if indicated
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Look for pallor/ icterus
2.2. Systemic Examination -
Examine chest and cardiovascular system
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Examine abdomen for abdominal mass, scars and distension. Check for rigidity and rebound tendernes
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3. Pelvic Examination
Before starting the pelvic examination, inform the woman and take verbal consent from her. Also ensure that:
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Privacy is maintained
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Equipment is ready
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Woman has emptied her bladder
3.1 Examination of external genitalia
Inspect the external gene Talia: labia major, minor and introits for redness, ulcer, growth, warts, swelling and discharge
3.2 Speculum Examination o Inspect the vagina and cervix for ulcer, foul smelling discharge and bleeding o If there is an erosion, cervix bleeds on touch or a growth, refer to a specialist o If there is any evidence of infection , perform the procedure under antibiotic cover 3.3. Bimanual Examination
There is one of the critical steps, helpful in comparing the size of the uterus to the period of amenorrhea. During bimanual examination: o Feel the cervix for consistency and tenderness on movement. A soft cervix is indicative of pregnancy. Tenderness on movement is indicative of pelvic inflammatory disease or ectopic pregnancy o Feel the position of the uterus and assess the size of the uterus .Also feel the shape , consistency and mobility of the uterus o Feel through the furnaces for adnexa (ovary and fallopian tube). Tenderness in the adnexa or mass felt in the adnexa is indicative of PID or ectopic pregnancy. Such cases should be referred / treated in appropriate higher level of facilities. Uterine Size Bigger than expected but has smooth and soft surface
Possible Conditions - Molar pregnancy - Multiple pregnancy
Line of Action USG if available or refer to an appropriate centre
- Wrong dates Bigger than expected, irregular and firm
Pressure of Fibroids with Pregnancy
USG if available or refer to an appropriate centre
Smaller than expected
- Wrong dates
USG if available or refer to an appropriate centre
- Non- pregnant uterus - Ectopic Pregnancy
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Establishing the period of gestation may be difficult in cases of: »»
The woman does not remember date of last menstrual period.
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Conception during Lactational Amenorrhoea.
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Wrong dates provided intentionally by the woman.
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Missed or incomplete abortion.
4. Laboratory Test »»
Ultrasound may be helpful for accurate dating when there is a discrepancy in the size of the uterus by LMP and bimanual examination. However, this test is not a mandatory. It can detect ectopic pregnancies
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Haemoglobin
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Urine for albumin and sugar
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Blood group/ RH (wherever possible). All women and primi gravid for second trimester MTPs must be tested for ABO and Rh blood grouping. For multigravidas it should be done wherever feasible. All Rh –vet women should preferably be advised/ administered anti-D immediately after the abortion procedure or within 72 hours of the procedure , the dose of which for first trimester MTP will be 50 mcg and second trimester MTP will be 300mcg
Methods of abortion There are a number of different methods of abortion. The method recommended will depend on how many weeks pregnant the lady is. This is usually calculated by counting the number of weeks from the first day of her last period.
6.1. Medical Abortion Early medical abortion (up to nine weeks of pregnancy) After the woman is found suitable to undergo pregnancy termination with medical methods, the following clinical protocol is followed: First Visit, Day 1 yy Mifepristone (200 mg) is administered orally yy Anti –D (50 mug) is given to Rh negative woman Before the woman leaves the facility: yy Instruct her to maintain a record of her symptoms in the client card given to her. yy Provide her with address and phone numbers of back up facility where she can contact in case of emergency.
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yy Ask her to return to the clinic after 48 hours. yy A small percentage of women (3%) may expel products of conception with mifepristone alone, but total drug dosage schedule with misoprostol must be completed. yy Home administration of misoprostol may be advised at the discretion of the provider in certain cases where the woman has an access to 24 hour. emergency services. In case of home administration of misoprostol, the woman needs to be provided with: yy Antiemetics yy Analgesics yy Additional dose of misoprostol to be repeated in the conditions mentioned below Second Visit, Day 3 On her second visit, note any history of bleeding or other side effects and proceed with the following: yy Administer misoprostol 400 mcg orally / vaginally for gestation age up to seven weeks. yy Observe the woman for four hours in the clinic / hospital and monitor: »»
Pulse and blood pressure
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Time of start of bleeding and expulsion of products (if it occurs)
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Side effects of the drugs
yy Perform a pelvic examination before the woman leaves the clinic and if cervical so is open and products are partially expelled, remove them digitally. yy Prescribe drugs for pain relief, if required. Non-narcotic and narcotic analgesic such as Paracetamol (Acetaminophen) with or without codeine, or Ibuprofen should be provided. Nonsteroidal anti anti-inflammatory drugs (NSAIDS) don’t interfere with Misoprostol. Before the woman leaves the facility: yy Instruct her to take adequate rest and avoid travelling yy Tell her that she should report in case of excessive pain or bleeding; (bleeding heavy enough to completely soak two pads an hour for two consecutive hours or more) yy Tell Her to use a contraceptive method if she has intercourse Provide her with: »»
Analgesics
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Anti-emetics
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Additional dose of misoprostol, to be repeated in the case of vomiting within half an hour of taking tablets.
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Condoms
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Third Visit, Day 15 During her visit on day 15: yy A clinical history is taken and pelvic examination is done to ensure the complete expulsion of the products of conception. yy Ultrasonography is required if history and examination do not confirm expulsion of products of conception Before the woman leaves the facility: yy Tell her that her next period may be delayed but should come for a check-up if she does not menstruate in six weeks. yy Counsel her for contraception and provide her the chosen contraceptive method, if she has not started it. Protocols for Mifepristone and Misoprostol Gestational age Up to 49 days
Mifepristone on Day 1 200 mg (one 200 mg tablet), orally
Misoprostol on day 3 400 mcg (two 200 mcg tablets), orally / vaginal
(For MTP for gestation between 49-63 days the central drugs standard control organization has approved a comb pack of one 200mg tablet of mifepristone and four 200mcg tablets of misoprostol)
Advantages of medical methods of abortion Abortion can be offered at early stage with minimum technical assistance. There is more privacy and less overall complication rate. Since no instrument/anaesthesia is required and hence this is not invasive. There is no effect on future fertility.
Contraindications Medical Methods of abortion are contraindicated in women with: yy Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass, as mifepristone is not an effective treatment for ectopic pregnancy. yy Anaemia (Haemoglobin <8 gm. %) yy Uncontrolled hypertension with B.P. > 160/100 mmHg: yy Cardiovascular disease such as angina, alular disease, arrhythmia yy Coagulopathy or women on anti-coagulant therapy yy Chronic adrenal failure or current long term use of systemic corticosteroids
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yy Severe renal, liver or respiratory disease yy Uncontrolled seizure disorder yy Inherited Porphyria yy Glaucoma yy Allergy or intolerance to mifepristone/ misoprostol or other prostaglandins Psychosocial situation unsuitable for medical methods of abortion yy Women who are unable to adhere to the protocol due to social and personal reasons yy Women who want quick abortion yy
Language or comprehension barrier
6.2. Vacuum Aspiration In this, contents of uterus are evacuated through a plastic/ metal cannula that is connected to a vacuum source. Hand held syringes are used to aspirate products of conception. Electric operated suction instruments are also used for suction. This method is also suitable for early termination of pregnancy. This is safe up to 12 weeks of pregnancy. Several studies have demonstrated safety and effectiveness of these methods. Specific benefits include reduced need for cervical dilatation, reduced risk of cervical injury, reduced infections and blood loss. Major complications are two to three times higher in conventional D and C procedures. It is important that all efforts are made to replace Dand C with safer methods.
Complications and Management A large number of women undergo unsafe abortions and almost one woman dies every two hours due to complications. Therefore, proper case selection, adequate counselling and appropriate referral are the key to the success of medical methods of abortion. Also, the woman should be informed about the possible complications and where /whom to contact for emergency services. a. Failure of the method Failure of the method of abortion is when vacuum aspiration is performed for any reason including clinicianâ&#x20AC;&#x2122;s decision, patientâ&#x20AC;&#x2122;s choice or a true drug failure. True drug failure is defined as the presence of gestational cardiac activity two weeks following the administration of mifepristone and misoprostol. It occurs in less than onepercent of women and pregnancy should be terminated by vacuum aspiration.
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b. Heavy Bleeding Bleeding is likely to be heavier than regular menses, comparable to that of a miscarriage. She should be told that soaking two pads per hour for two hours in a row is all right at the time of peak cramping which is often the case during the expulsion of the products of conception. However, if this persists and /or the woman is dizzy, she should consult the doctor. Severe bleeding necessitating surgical evacuation is reported in less than one percent of patients. If needed it may be done depending on: »»
The clinicians assessment blood loss
»»
Presence of circumstances that make it difficult for the woman to obtain emergency help later
»»
Woman’s preference
c. Abdominal Cramps Crimpy abdominal pain is experienced by most women for a short time. Pain relief is an important part of the therapy. Often, women are relieved by Paracetamol. A mild opioid such as oxycodone is often added to Paracetamol if required. Pain usually subsides once the products are expelled. Persistent pain, with failure to respond to these drugs for several hours, warrants evaluation for other causes such as ectopic pregnancy, infection or incomplete abortion d. Fever or a feeling of warmth It is thought to be a component of the prostaglandin analogy used. It is usually short lived and resolves spontaneously. Acetaminophen (Paracetamol) given for pain relief also takes care of fever, but if temperature exceeds 100.4 F (38 degrees) or persists for several hours despite antipyretics, infection should be ruled out. e. Incomplete abortion Women having persistent gestational sac without cardiac activity two weeks after the administration of mifepristone and misoprostol are diagnosed to have incomplete abortion. Such women usually do not have pregnancy related symptoms and often spontaneously expel the products of conception. Blood, blood clots and decidua present in the uterus despite expulsion of gestation sac may appear as hyper echoic tissue on ultrasonography and may be interpreted as incomplete abortion. In the absence of excessive bleeding, these patients should be followed conservatively. f. Risk of Teratogens It is advisable to terminate pregnancy surgically if it continues after drugs for medical abortion have been taken, due to the risk of possible teratogenicity. A written statement signed by the woman must be kept on record if surgical termination is refused. g. Delayed onset of next menses There might be a delay in the following menstrual period. Next menstruation can occur from 3-6 weeks after the abortion and is usually normal.
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For 24 hours after the procedure, the client should not do any of the following: yy Drink alcohol yy Drive yy Operate machinery yy Use appliances that could cause injury yy Make any major decisions
Frequently asked question 1. What factors should be taken into account when counselling a woman about her choice between medical and surgical abortion?
There is little, if any, difference between medical and surgical abortion in terms of safety and efficacy. Thus, both methods are similar from a medical point of view and there are only very few situations where a recommendation for one or the other method for medical reasons can be given. Two studies have found that women are more likely to find a method of abortion acceptable if they have chosen it themselves. Being provided with a choice of methods is seen as extremely important by the majority of women undergoing abortion. Many studies suggest that women who choose medical abortion find it more acceptable at earlier than later gestations.
Medical abortion may be preferred: yy
If it is the womanâ&#x20AC;&#x2122;s preference;
yy
In very early gestation; up to 49 days of gestation, medical abortion is considered to be more effective than surgical abortion, especially when clinical practice does not include detailed inspection of aspirated tissue
yy
If the woman is severely obese (body mass index greater than 30) but does not have other cardiovascular risk factors as surgical treatment may be technically more difficult;if the woman has uterine malformations or a fibroid uterus, or has previously had cervical surgery (which may make surgical abortion technically more differ cult);
yy
If the woman wants to avoid a surgical intervention.
Surgical abortion may be preferred: yy
If it is the womanâ&#x20AC;&#x2122;s preference, or if she requests concurrent sterilization;
yy
If she has contraindications to medical abortion
yy
If time or geographical constraints preclude the follow-up needed to confirm that abortion is complete.
2. What are the contraindications to medical abortion? There are very few absolute contraindications to medical abortion. They include: yy
Previous allergic reaction to one of the drugs involved;
yy
Inherited porphyria;
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yy
Chronic adrenal failure;
yy
Known or suspected ectopic pregnancy.
Caution is required in a range of circumstances including: yy
If the woman is on long-term corticosteroid therapy (including those with severe, uncontrolled asthma);
yy
If she has a haemorrhagic disorder;
yy
If she has severe anaemia;
yy
If she has pre-existing heart disease or cardiovascular risk factors (e.g. hypertension and smoking).
3. Do any other characteristics of the woman need to be taken into account in providing medical abortion? yy
Age - Neither adolescence nor older age (e.g. over 35 years) should be regarded as a contraindication to medical abortion.
yy
Anaemia - This need not be regarded as a contraindication. However, anaemia detected at the time of abortion should be treated. Average blood loss in medical abortion may be more than that in surgical abortion, and the incidence of heavy bleeding may be higher.
yy
Breast feeding - It is likely that mifepristone passes into breast milk. Studies investigating the endocrine effects of mifepristone on the foetus have found increased levels of adrenocorticotropic hormone and cortisol. The clinical implications of these changes are unclear. Small amounts of misoprostol also enter breast milk soon after administration, but it is not known whether this could have any effect on the infant. As misoprostol levels decline rapidly, it has been recommended that misoprostol should be taken immediately after a feed and the next feed given after four hours in case of oral administration. After vaginal Administration, misoprostol levels stay high for longer, and the feed should preferably be given more than six hours later. Unfortunately, the available data do not allow a precise recommendation on optimum timing.
yy
Insulin - dependent diabetes or thyroid disorder. There is no evidence that medicalabortion causes particular problems in women with these disorders. However, mifepristone has been shown to alter insulin sensitivity in vitro and these effects may or may not be reflected in blood sugar and insulin levels.
yy
Multiple pregnancies - There is no evidence that the failure rate of medical abortion is increased or that a different dosage regimen is required in the case of multiple pregnancies.
yy
Obesity - There is no evidence that the failure rate of medical abortion is increased or that a different dosage regimen is required in obese women.
yy
Previous Caesarean section - There is evidence from one study that the safety and efficacy of early medical abortion are unaffected by previous Caesarean section.
yy
Smoking - There is no evidence of interaction between the risks of smoking and medical abortion. However, smoking contributes to cardiovascular risk and this factor should be considered when assessing a womanâ&#x20AC;&#x2122;s overall suitability for medical abortion.
yy
Uterine malformations, congenital and acquired; previous cervical surgery. There is no evidence that these represent contraindications.
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4. How should pregnancy be confirmed and gestation estimated?
In most cases, pregnancy can be confirmed and its length estimated on the basis of the womanâ&#x20AC;&#x2122;s history and a physical examination. Occasionally, laboratory tests may be needed when the typical signs of pregnancy are not clearly present and the health-care provider is unsure whether the woman is pregnant. Ultrasound scanning is not necessary for the provision of early abortion. Where ultrasound equipment is available, a scan can help identify an intrauterine pregnancy and exclude an ectopic one after about six weeks. It also helps determine gestational age and diagnose Pathologies or non-viability of a pregnancy.
5. What clinical assessment and laboratory investigations are required prior to medical abortion?
As for any method of abortion, clinical history-taking should serve to identify contraindications and to identify risk factors for complications. History-taking should include: personal and family history of relevant diseases; current use of medications and known allergies; obstetric and gynaecological history, including ectopic pregnancies; any bleeding tendencies; and history of sexually transmitted infections. Social history should include risk assessment for STIs, taking into account local STI prevalence rates. The clinician must be alert to the possibility of violence or coercion in the context of the unwanted pregnancy.
Basic routine observations (pulse, blood pressure, and temperature) are useful as a baseline. There are no laboratory tests that are essential before medical abortion. However, tests such as haemoglobinlevel, blood group and rhesus (Rh) typing, and screening for hepatitis,HIV and STIs, may be offered on the basis of individual risk factors or available resources. Ideally, services should offer testing for pathogens in the lower genital tract, and treat women found positive.
Rhesus status - The prevalence of Rh-negative status varies markedly with ethnicity, being highest among Caucasians. For pregnancies up to 63 days gestation, the theoretical risk of maternal Rh sensitization is very low; there is no evidence that sensitization occurs at this stage of pregnancy. Thus, determination of blood group and Rh status and the offer of anti-D prophylaxis to Rh-negative women are not considered prerequisites for early medical abortion. In settings where the prevalence of Rh-negative status is high, and where resources permit, the offer of Rh typing and anti-D prophylaxis could be worth while as precautionary components of medical abortion care.
6. Is the interval between administration of mifepristone and prostaglandin crucial?
The licensed and most commonly used interval, of 36â&#x20AC;&#x201C;48 hours, corresponds to the time when the uterus is most sensitive to prostaglandin after priming with mifepristone; hence the therapeutic dose can be reduced to the minimum. This interval was also found to be the most effective in initial studies when uterine contractility was measured at different times between administration of mifepristone and of prostaglandin. It has been shown recently, however, that the interval can be shortened to 24 hours or lengthened to 72 hours, without loss of efficacy, when Mifepristone is used in combination with 0.8 mg of vaginally administered misoprostol. If misoprostol is given as an oral dose of 0.4 mg, the interval of 36â&#x20AC;&#x201C;48 hours should be adhered to. Other time intervals are currently being studied.
7. What pain relief should be available to women during medical abortion?
Pain is caused both by the abortion process and as a side-effect of the prostaglandin. It is most likely to be felt in the few hours after administration of the prostaglandin, when the gestational sac/embryo is being expelled from the uterus. Studies have shown that women feel less pain if they are older, have been pregnant before or are in the early stages of pregnancy. However, none of these factors is sufficiently predictive to be useful in the management of individual cases. The perception of pain and request for relief vary greatly from one individual to another and among cultures. In any case, health-care providers should make adequate analgesia easily available to all women who request it during medical abortion. Examples
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of commonly used preparations are: Paracetamol 500–1000 mg or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen 200 mg. In cases of severe pain, codeine 30–40 mg may be added to either of the above-mentioned treatments.
8. If a woman has an incomplete abortion, is it necessary to evacuate the uterus surgically?
On average, vaginal bleeding gradually diminishes over about two weeks after a medical abortion, but in individual cases spotting can last up to 45 days. Generally, bleeding after medical abortion lasts longer than after vacuum aspiration. If the woman is well, neither prolonged bleeding nor the presence of tissue in the uterus (as detected by ultrasound) is an indication for surgical intervention. Remaining products of conception will be expelled during subsequent vaginal bleeding. Surgical evacuation of the uterus may be carried out on the woman’s request or if the bleeding is heavy or prolonged, or causes anaemia, or if there is evidence of infection. In the latter case, antibiotic treatment should be initiated.
9. How should the success of medical abortion be confirmed?
For all women who undergo medical abortion, it is important to confirm that the pregnancy has indeed been terminated. If expulsion of the products of conception was confirmed by a qualified person in the hours after administration of the prostaglandin, further follow-up is not absolutely necessary. Otherwise, a follow-up visit should be arranged about two weeks after the administration of mifepristone, at the convenience of the patient. At the follow-up visit, complete abortion should be confirmed clinically, either by bimanualpelvic examination or, if available, pelvic ultrasound. If serial measurements of human chorionic gonadotropin (HCG) in blood or urine are used, it should be remembered that in some cases low HCG levels can be detectable for up to four weeks after successful expulsion. Women who continue to have symptoms of pregnancy or who have minimal bleeding are most likely to be still pregnant.
10. Is there a risk of fetal abnormality after an unsuccessful medical abortion?
Only one anomaly has been reported after the use of mifepristone alone. This case,described as a Sirenomelia, could not be related to the drug intake. Indeed, this typeof anomaly occurs at a very early stage of pregnancy – at about four weeks of embryo development – while the treatment was taken in the fifth week of pregnancy. Thirteen other cases of malformation have been reported: all occurred in pregnancies in which mifepristone was administered at 7–9 weeks of amenorrhoea, followed in eight cases by gemeprost and in five cases by misoprostol. None of the events could be conclusively related to the treatment.
It is not possible to determine whether the reported anomalies were caused by the treatment, since the incidence of birth defects in a normal population is around 2 per 100 births. Some prostaglandins have been classified as teratogenic, although misoprostol did not induce such effects in embryotoxicology studies. Mifepristone is not a Teratogenicity agent but, when used in combination with a prostaglandin, may induceuterine contraction, which could account for some of the observed defects. Since the available data are limited and inconclusive, there is no need to insist on termination of an exposed pregnancy if the woman wishes to continue it. Women should,nevertheless, be informed that because of the unknown risk of abortifacient drugs to the foetus, follow-up is important.
11. Which methods of contraception can a woman use after medical abortion?
Most women who have an induced abortion for an unwanted pregnancy do not want to get pregnant again immediately. In a few cases, there may be medical reasons for avoiding immediate pregnancy. Postabortion family planning is therefore an integral part of comprehensive abortion care. Women who have had an early abortion are almost immediately at risk of becoming pregnant again. Ovulation may occur as early as day 10 after a first-trimester abortion. Up to 78 percent of women in one study had ovulated by
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the time of the six-week follow-up. Women who have had a medical abortion can use any modern method of contraception afterwards. When the woman is counselled about the abortion, the opportunity should be taken to review her contraceptive needs. Ideally, she should be provided with an effective contraceptive method immediately after the abortion. Combined oral contraceptive pills can be started on the day that misoprostol is administered, when expulsion usually occurs. Two prospective randomized controlled studies evaluated the effects of immediate use of combined oral contraceptive pills versus placebo following medical abortion and found no difference in complete abortion rates, side-effects and duration of bleeding. Progestogen-only methods are commonly associated with breakthrough bleeding, which may be confused with an incomplete abortion. Depot-Medroxy progester one injections and implants are often associated with amenorrhoea, or irregular bleeding, which may make it difficult to determine whether pregnancy has been terminated. It may therefore be preferable to start using these methods only after it has been confirmed that the pregnancy has been terminated. Sterilization and insertion of an intrauterine device should be deferred until confirmation that the abortion is complete. Women who choose a contraceptive method that cannot be started immediately should be encouraged to use condoms in the meantime. Other methods, such as caps, sponges, diaphragm, spermicidal foams, jellies and vaginal tablets, can be used as soon as sexual intercourse is resumed, preferably when bleeding has stopped. Methods of natural family planning can be resumed only after the return of regular cycles.
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Chapter 7
PC-PNDT Act
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Chapter 7: PC-PNDT Act
Sex Selection? Sex selection is the practice of determining the sex of the unborn foetus and eliminating it if found to be female. In recent years, the use of ultrasound technology has become the most common mode of sex determination followed by elimination of the female.
Child Sex Ratio and Sex Ratio at Birth The child sex ratio reflects the imbalance between the number of girls and boys, indicating that the practice of sex selection (along with other factors such as selective neglect of girls) have led to a drastic decline in the number of girls compared to the number of boys. When the ratio is calculated at birth (i.e. the number of girls born per 1000 boys), it provides a clearer indication of sex selection, which happens before birth. Though sex ratio at birth is a better indicator of pre-natal sex selection, the child sex ratio is still most widely quoted because of its easy availability at the district level and throughout the country. Child Sex Ratio is calculated as the number of girls per 1000 boys in the 0-6 year age group. In India, the ratio has shown a sharp decline from 976 girls to 1000 boys in 1961 to 914 as per the 2011 census. The decline has been the sharpest from 1981 onwards. The fall to 927 in the 2001 census is alarming, especially since the country seems to be registering an upward growth in other areas. This clearly indicates that economic prosperity and education have no bearing on the sex ratio â&#x20AC;&#x201C; or in other words, in changing the traditional preference for sons over daughters. The sex ratio at birth for the country for 2007-09 is estimated as 906 girls born for every 1000 boys. Today, the north-western states, where the sex determination clinics first made their presence felt, have the lowest child sex ratios. In Punjab and Haryana, there are less than 900 girls for every 1000 boys.
Root cause of sex selection and son preference in India In India, gender based sex selection in favour of boys is a symptom of pervasive social, cultural, political and economic injustices against women and a manifest action of gender discrimination. This issue needs to be seen in the context of a male-dominated social and family structure and a value system based on son preference. Further, the practice of dowry and the tag of â&#x20AC;&#x2DC;parayadhanâ&#x20AC;&#x2122; translate into daughters being seen as liabilities. Discrimination and neglect of the girl child could be in terms of inadequate nutrition, denial or limited access to education and health, and domestic violence. In one of its worst forms, it leads to complete rejection of daughters even before birth, as practiced through sex selection. In recent years, it has been perpetuated by the illegal use of diagnostic technologies coupled with unethical medical practices.
Impact of sex selection The adverse child sex ratio can severely impact the delicate equilibrium of nature and damage the moral and social fabric. Contrary to what many believe, fewer girls in a society will not enhance its 132
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status. Instead, it could lead to increased violence against women, rape, abduction, trafficking and a resurgence of practices such as polyandry (more than one man marrying one woman). In some parts of the country, women are already being â&#x20AC;&#x2DC;boughtâ&#x20AC;&#x2122; as brides, making commodification of women a real threat.
PCPNDT Act The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act regulates sex selection, before or after conception. The law was first enacted in 1994 and amended in 2003. Its purpose is to prevent misuse of technologies such as ultrasound that enable testing the sex of the foetus and eliminating girls. It is illegal to test the sex of the foetus for non-medical reasons. The law provides for imprisonment, which may extend to three years and fine up to Rs. 10,000 for the first conviction. Key steps for complying with PCPNDT Act yy Register the facility including the machine and display the registration certificate. yy Inform the appropriate authority of any change in the machine, facility or qualified staff. yy Maintain transparent and complete records. yy Preserve records for up to two years. yy They have to be made available at the time of inspection. Under what circumstances can pre-natal diagnostic techniques to be offered to pregnant woman? yy Age > 35 years: Since it is known that after the age of 35 years the incidence of congenital foetal malformations increases. yy Previous two or more spontaneous abortions/foetal loss. yy Exposure to potential teratogenic agents such as radiation, drugs, infection, chemicals. yy Family history of mental retardation or physical deformities such as, spasticity or any other genetic disease.
Abortion rights In India, abortion is legal under certain circumstances as defined by the Medical Termination of Pregnancy Act, 1971. The law does not permit abortion for the reason of sex selection. It is important to recognize this fact and not consider that abortion per se is illegal. A woman needs to have rightful access to safe and legal abortion services as per the MTP Act. From a gender equality perspective, sex selection is a reflection of discrimination against girls and subordination of women as a group. Equally important is to remember that not providing women access to safe abortion services for legally valid reasons further deepens their subordination. Access to safe and legal abortion is also necessary to prevent maternal death and related ill health. 133
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Punishments under the Act Offence/ Offender
Punishment
Breach of any provision of the Act by any service 3 years imprisonment and / or fine of Rs. 10,000 providers For subsequent offence
5 Years imprisonment and/ or fine of Rs. 50,000
Medical Professionals
The AA will inform the State Medical Council and recommend suspension of the offenders registration. Removal of name from register for 5 years on first conviction Imprisonment extending upto 3 years and / or fine of Rs. 50,000.
Persons seeking to know the sex of the foetus. (A woman will be presumed to have been compelled to undergo sex determination tests by her husband and relatives. If the presumption is not dispelled, then the person concerned will be punishable for abetment of the offence) For subsequent offence
Imprisonment upto 5 years and / or fine of Rs 1,00,000
Persons connected with advertisement of sex selection / sex determination services
Imprisonment upto 3 years and / or a fine of Rs. 10,000 with additional fine of continuing contravention at the rate of Rs. 500 per day
Contravention of provisions of the Act or rules for which specific punishment is provided with Act/ Rule
Imprisonment upto 3 months and /or fine of Rs. 1,000 with additional fine of continuing contravention at the rate of Rs. 500 per day.
Persons to be punished: yy Person who performs the test. yy Every person in charge of and responsible for the conduct of business of the Genetic Centre (GC), Genetic Counselling Centre (GCC) or Genetic Laboratory (GL). yy Owner, director or the manager of the company , which runs the Genetic Centre , Genetic Counselling Centre or Genetic Laboratory. yy Mediator who is responsible for directing the pregnant woman to such a unit. yy Husband / Family of the pregnant woman. yy All other relatives of the pregnant woman who are responsible for forcing her or helping her undergo pre-natal sex detection. yy The pregnant woman herself is considered innocent under the Act, unless and until proved otherwise. If it is proved that she approached the unit for pre-natal sex detection without any compulsion, then she is considered guilty. The code of conduct to be followed by all persons employed in GCC, GL, Ultasound Clinics, Imaging Centres registered under the Act / Rules
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Code of conduct by Ultrasound and Imaging clinics under the Act yy Display information at the clinic: Registration certificate, copy of the Act and a display board in English and a local language saying â&#x20AC;&#x2DC;DISCLOSURE OF THE SEX OF THE FOETUS IS PROHIBITED UNDER LAW RULE 17(1) yy Maintain Records as Prescribed by Law Mandatory Records Register showing in serial order yy Name and addresses of men or women given genetic counselling and/or subjected to prenatal diagnostic procedure or test. yy Names of their spouses of fathers; yy Date on which they first reported for such counselling For every case yy The referrals of the doctor recommending the scan yy A declaration by the doctor that he/she has neither detected nor disclosed the sex of the foetus to anybody in any manner yy A declaration from the pregnant women regarding her non-interest in knowing the sex of the foetus Maintain forms as prescribed by Rules of the Act yy Maintain Form D (Records for genetic Counselling Centre), E (Records for genetic Laboratory) and F (Record for the pregnant women by ultrasound clinics, etc) yy Multiple copies of forms can be photocopied from the PCPNDT Handbook on Act and Rules yy Send complete report based on above forms statutorily by 5th of the succeeding month (for the previous month) to the Appropriate Authority or any officer so authorized. Other Medical Records: Other records that are kept by the clinic include: yy Case Record yy Forms of consent for invasive procedures (form G) yy Laboratory results, microscopic pictures and sonographic plates or slides yy Recommendations and letters from referring doctor (i) Not conduct or associate with, or help in carrying out detection or disclosure of sex of foetus in any manner. (ii) Not employ or cause to be employed any person not possessing qualifications necessary for carrying out pre-natal diagnostic techniques/ procedures, techniques and tests including ultrasonography.
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(iii) Not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or procedure for selection of sex before or after conception or for detection of sex of foetus except for the purposes specified in sub- section (2) of section 4 of the Act. (iv) Not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or test or procedure under the Act at a place other than a place registered under the Act / these Rules. (v) Ensure that no provision of the Act and these Rules are violated in any manner. (vi) Ensure that the person conducting any techniques, test or procedure leading to detection of sex of foetus for purposes not covered under section 4(2) of the Act or selection of sex before or after conception, is informed that such procedures lead to violation of the Act and these Rules which are punishable offences. (vii) Help the law enforcing agencies in bringing to book the violators of the provisions of the Act and these Rules. (viii) Display the medical professional’s name and designation prominently on their dress. (ix) Write his/her name and designation in full under his/her signature. (x) On no account conduct or allow/cause female foeticide to be conducted. (xi) Not commit any other act of Professional misconduct. Responsibility of the Medical Professionals 1. To say “No” to requests for performing sex selection, sex detection and gender-specific MTPs and to discourage colleagues from doing so. 2. To register Genetic Centres. 3. To counsel women/couples and their families and dissuade them from knowing the sex of the foetus. 4. To enlighten society about erring doctors who conduct prenatal sex detection and female – specific MTPs.
To regularly have stock–taking on the prevalence of sex determination and sex selection by professional bodies such as the Indian Medical Association and to publish articles and statements on the subject to give prominent focus to the issue.
6. To himself/herself sincerely abide by the Act and its spirit. 7. To blow the whistle on those in the fraternity who are conducting these tests and practices. They should be immediately reported to the concerned Appropriate Authority.
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Amendments in the Act in 2012 Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994), the Central Government hereby makes the following further amendments to the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996 namely: 1. “(1) These rules may be called the Pre-conception and Pre-natal Diagnostic Techniques(Prohibition of Sex Selection) Amendment Rules, 2012.(2) They shall come into force on the date of their publication in the Official Gazette.” 2. In the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996 (hereinafter referred to as the said rules), after rule 3, the following shall be inserted, before rule 3A, namely: “(3) Each medical practitioner qualified under the Act to conduct ultrasonography in a genetic clinic/ultrasound clinic/imaging centre shall be permitted to be registered with a maximum of two such clinics/centres within a district. The consulting hours for such medical practitioner, shall be clearly specified by each clinic/centre”. 3. In the said rules, in rule 5 in sub-rule (1), the following sub-rule,- “In item (a) for the letters and figure “Rs. 3,000.00”, the words “rupees twenty five thousand” shall be substituted. In item (b) for the letters and figure “Rs 4,000.00”, the words “rupees thirty five thousand” shall be substituted.” 4. In the said rules, in rule 13, for the words “within a period of thirty days of such change”, the words “at least thirty days in advance of the expected date of such change, and seek re-issuance of certificate of registration from the Appropriate Authority, with the changes duly incorporated” shall be substituted.
Frequently asked Question 1. Is the act against technology?
The Act and the campaign for its implementation are not against the technology per se, but demand the ethical use of pre-natal diagnostic technology. If technology is used to only selectively eliminate the female foetus, then doctors need to question the use of this technology.
2. What are the commonly used techniques for sex selection?
I. Pre- conception Techniques
a. Pre- Implantation Genetic Diagnosis (PGD)
b. Sperm sorting and sperm separation
II. Pre- natal diagnostic Techniques (PNDT) a. Amniocentesis
b. Chorion Villus Biopsy
c. Sonography
III. Other methods include Ayurvedic Therapies
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3. Where can these tests be conducted? And who can conduct these tests?
These tests can be conducted at the following premises»»
Genetic Counselling Centres (GCC) including maternity clinics, nursing homes, gynaecological clinics
»»
Genetic Clinics
»»
Genetic Laboratories
»»
Ultrasound Clinics and Imaging Centres
These tests can be conducted by »»
Registered Medical Practitioner with six months training or one year experience with any recognized medical qualification under the Indian Medical Council Act, 1956 and whose name is entered in the State Medical Register
»»
Gynaecologist possessing a post graduate degree in Gynaecology and Obstetrics
»»
Medical Geneticist possessing a degree or diploma in genetic science
»»
Paediatrician possessing a post – graduate degree in Paediatrics.
4. Can a medical Professional perform pre-natal diagnostic technique on a pregnant woman without her consent?
The Act gives full right to the pregnant woman to know: what procedure is to be performed; good and bad effects of such a test on her and her foetus; types of results expected of such a test; type of information that will not be looked for and conveyed to her with this test; what will be the advantages of taking the test and disadvantages of not taking the test.
5. Is there any test where informed consent is not required?
After the amendments to the Act, there has been a bifurcation of procedures adopted for invasive and non-invasive tests. Invasive tests are those which have the risk of causing miscarriage- for example, amniocentesis, CVS and Foetal blood sampling. Non-invasive tests such as Ultrasound do not carry a risk; hence consent of the pregnant woman need not be taken. However, before taking the test, the woman has to give a declaration stating that she does not want to know the sex of the foetus. Similarly, the medical professional conducting the test has to declare that he/she will neither detect nor disclose the sex of the foetus to any person.
6. What is the procedure for registering a Genetic Clinic, Counselling Centre or a Laboratory?
The owner has to apply to the Appropriate Authority (the chief Medical Officer at the district where the unit is situated or the officer appointed in the sub district). All applications are to be made in duplicate in Form A and must be accompanied by enclosures containing details of equipment available, the make and model of each piece of equipment and the names, qualifications, registration number and experience of medical professionals.
The registration fee for a Genetic Clinic is Rs. 3,000. However,Genetic Clinic is Rs. 3,000. However, if the centre is providing more than one service as a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic then it is Rs. 4,000. This fee is non-refundable and irrespective of the number of USG machines in the centre.
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7. Can non- allopathic medical professionals perform USG?
No non-allopathic medical professionals cannot perform USG.
8. What is validity of the registration certificate? How does the owner renew the registration?
Five years, provided there is no violation under the Act. An application for renewal should be made in duplicate through Form A to the AA 30 days before the expiry date of the registration. The registration would be renewed after conducting an enquiry and with suggestions from the Advisory committee. The renewal fee is half of the original fee.
9. What should the scan Centres do under the Act?
Display
Registration certificate, PNDT board and Pamphlets;
Records
Mandatory records
Register showing in serial order:
»»
Name and address of men/women given genetic counselling and / or subjected to prenatal diagnostic procedure or test.
»»
Names of their spouses or fathers.
»»
Dates on which they first reported for such counselling.
The scan centre shall send consolidated report on Form F statutorily by the 5th of the following month for the previous month, to the Appropriate Authority or any officer so authorized. Other kinds of records include: »»
Case records
»»
Forms of consent
»»
Laboratory results
»»
Microscopic pictures
»»
Sonographic plates or slides
»»
Recommendations and letter
10. If the owner is convicted under the Act and undergoes punishment, what is the status of registration of his unit?
In such a case, when charges are framed against him, the registration of his unit is suspended or cancelled, prohibiting any pre-natal diagnostic or counselling from being carried out there. In such an event, the Appropriate Authority can grant the registration, depending on whether the units meet the requirements laid down in the Act and the Rules.
11. Who can be punished under the Act? »»
Person who performs the test. 139
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»»
Every person in charge of and responsible for the conduct of business of the Genetic Centre, Genetic Counselling Centre or Genetic Laboratory.
»»
Owner, director or the manager of the company which runs the Genetic Centre, Genetic Counselling Centre or Genetic Laboratory.
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Mediator who is responsible for directing the pregnant woman to such a unit.
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Husband / Family of the pregnant woman.
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All other relatives of the pregnant woman who are responsible for forcing her or helping her undergo pre-natal sex detection.
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The pregnant woman herself is considered innocent under the Act, unless and until proved otherwise. If it is proved that she approached the unit for pre-natal sex detection without any compulsion, then she is considered guilty.
12. Is sex selection caused by poverty and illiteracy?
No this is a myth. This practice is prevalent right across the country, even in regions which are prosperous and people are literate.
13. Does the mother have the right to choose the sex of her future child?
Fear of violence and desertion and desire to establish one’s value in the family mean that woman feels pressured to have sons and therefore opt for sex selection. This can hardly be called as a couple’s choice. As per the law, the right to bring into existence a life in future with a choice to determine the sex of that life cannot in itself be a right. The view is that sex selection cannot be treated as a matter of right and choice as it promotes discrimination.
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8.1. Accreditation under Government of India Public-Private Partnership Scheme Understanding Public Private Partnership Public-Private Partnership or PPP in the context of the health sector is an instrument for improving the health of the population. PPP is to be seen in the context of viewing the whole medical sector as a national asset with health promotion as goal of all health providers, private or public. The Private and Non-profit sectors are also very much accountable for the success of the overall health systems and services of the country. Therefore, synergies where all the stakeholders feel they are part of the system and do everything possible to strengthen national policies and programmes need to be emphasized, with a proactive role from the Government. However for definitional purpose, “Public” would define government or organizations functioning under State budgets, “Private” would be the Profit/Non-profit/Voluntary sector and “Partnership” would mean a collaborative effort and reciprocal relationship between two parties with clear terms and conditions to achieve mutually understood and agreed upon objectives following certain mechanisms. PPP however would not mean privatization of the health sector. Partnership is not meant to be a substitution for lesser provisioning of government resources nor an abdication of government responsibility but as a tool for augmenting the public health system.1 Although it varies between regions and states, more than two thirds of health care activity in India takes place in the private sector, which is currently expanding more rapidly than the government sector. Though the economic weight of this sub-sector and the part of household budgets devoted to private health care are substantial, it remains largely unregulated.2 Over the years the private health sector in India has grown markedly. Today the private sector provides 58 percent of the hospitals, 29 percent of the beds in the hospitals and 81 percent of the doctors. (The Report of the Task Force on Medical Education, Ministry of Health and Family Welfare) The private providers in treatment of illness are 78 percent in the rural areas and 81 percent in the urban areas. The use of public health care is lowest in the states of Bihar and Uttar Pradesh. The reliance on the private sector is highest in Bihar. Seventy seven percent of out-patient department (OPD) cases in rural areas and 80 percent in urban areas are being serviced by the private sector in the country (60th round of the National Sample Survey Organisation [NSSO] Report. Branding of healthcare institutions as “government certified” etc. and with a specific brand name would help create a ready market of clients willing to “go an extra mile” to avail of services from such providers.3 Draft Report on Recommendation of Task Force on Public Private Partnership for the 11th Plan National Plan for RCH II 2005 3 The Principles and Evidence Base for RCH Phase II PIPs 1
2
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Objectives of PPP in Family Planning Universal coverage and equity for family planning services should be the main objective of the PPP mechanism besides: yy Improving quality, accessibility,availability, acceptability and efficiency. yy Exchange of skills and expertise between the public and private sector. yy Mobilization of additional resources. yy Improve the efficiency in allocation of resources and additional resource generation. yy Widening the range of services and number of service providers. yy Clearly defined sharing of risks. yy Community ownership.
Santushti Scheme Santushti is a Scheme of Jansankhya Sthirata Kosh (JSK) for the highly populated states of India viz Bihar, Uttar Pradesh, Madhya Pradesh, Rajasthan, Jharkhand, Chhattisgarh and Odisha. Under this scheme, JSK, invites private sector gynaecologists and vasectomy surgeons to conduct operations in Public Private Partnership mode. According to this Scheme, an accredited private Nursing Home/ Hospital (Quality assurance manual for Sterilization services), can sign a MOU with JSK. Upon signing the MOU the private Hospital/ Nursing Home shall be entitled for an incentive, whenever it conducts 10 or more Tubectomy/ Vasectomy cases in a month. To participate in this scheme, Private Hospitals/Nursing Homes may contact either the District Chief Medical & Health Officer or JSK. The quality assurance manual can also be accessed on mohfw.nic.in. Following terms regarding the Santushti Strategy will become applicable: 1. Accredited Private Hospitals/Nursing Homes, who conduct 10 Tubectomy (Female Sterilization) and Vasectomy (Male Sterilization) operations in a month, will be eligible for payment under the Santushti Strategy. 2. Private facilities conforming to the aforesaid criteria are entitled to claim Rs. 1500/- per case from National Rural health Mission (NRHM) funds while an additional amount of Rs. 500/- per case will be paid by JSK. 3. Now there is also a provision for payment of wage compensation to the clients undergoing sterilization operations equal to the sum paid to them in the public facility. i.e. Rs. 600/- for Tubectomy and Rs 1100/- for Vasectomy clients.
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Wage Motivators compensation to (Rs.) the beneficiaries (Rs.)
Type of Service
Type of facility
Incentive to the Providers
Tubectomy
Private
1850/-
150/-
600/-
2600/ (1500/- from NRHM Fund &the rest will be provided by JSK)
Vasectomy
Private
1800/-
200/-
1100/-
3100/- (1500/- from NRHM Fund &the rest will be provided by JSK)
Total (Rs.)
4. To streamline the functioning there will be a Tripartite MOU will be between the Private Health Provider, the State Health Society and JSK. 5. NGOs working in the state may also be eligible to participate in the Scheme if they will fulfil requisite criteria for quality assurance. The Scheme is currently available in following districts: Uttar-Pradesh: Bijnour, Gorakhpur, Farrukhabad, Barabanki, Aligarh, Badaun, Bareilly Rajasthan: Bharatpur, Ajmer, Tonk, Pali, Jodhpur Bihar: PurbiChamparan, Sitamarhi, Purnea, Katihar, Kishanganj Madhya Pradesh: Sagar, Jabalpur, Neemuch Accreditation of private hospital for Sterilization Services Qualification requirements for service providers4 yy Female sterilization by mini-laptubectomy should be performed by a trained MBBS/ post graduate doctor. yy Laparoscopic sterilization for females should be performed by a gynaecologist with DGO/ MD/MS qualification or by a surgeon with an MS degree; these doctors should be trained in laparoscopic sterilization. yy The male sterilization procedures, both conventional vasectomy and no-scalpel vasectomy (NSV), should be performed by a trained MBBS doctor/or a post graduate doctor. Empanelment of doctors for performing sterilization3 yy Approved panel of doctors: Each state will prepare a district-wise list of doctors (both from government and accredited private centres/NGOs) who are qualified to perform sterilization operations as per the prescribed eligibility criteria. 4
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Eligibility/Qualification of Doctors for Conducting Sterilization Procedures Female Sterilization An MBBS Doctor trained to carry out Minilap Tubectomy may perform mini-laptubectomy.
Male Sterilization Conventional Vasectomy can be performed by an MBBS Doctor trained in conventional Vasectomy.
Or Laparoscopic Tubectomy can be performed either by a Gynaecologist with DGO/MD/MS Degree and trained in Laparoscopic sterilization or by a surgeon with MS (Surgery) Degree and trained in Laparoscopic sterilization
An MBBS doctor trained in no-scalpel vasectomy may perform no-scalpel vasectomy.
yy Only those doctors whose names appear on the panel will be entitled to carry out sterilization procedures in the government and/or government-accredited institutions and will be covered under indemnity insurance. The panel will be updated quarterly. Compensation to private providers for IUD insertion For each IUD insertion at an accredited private facility Rs. 75 inclusive of the cost of the IUD would be admissible.
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Annexure 1: References 1. Ministry of Health and Family Welfare. 2010.Comprehensive Abortion Care Guidelines.[Online]. [Accessed on 15 April 2013]. Available from: http://mohfw.nic.in/NRHM/Documents/MH/ Comprehensive%20Abortion%20Care%20Training%20&%20Service%20Delivery%20Guidelines. pdf 2. Ministry of Health and Family Welfare. 2008.Guidelines for Administration of emergency contraceptive pills by Health care providers.[Online].[Accessed on 15 April 2013]. Available from http://mohfw.nic.in/NRHM/FP/ECP_Book_Final.pdf 3. National Consortium for Medical Abortions in India (2010).Guidelines for early Medical abortions in India using Mifepristone and Misoprostol. New Delhi. 4. The Federation of Obstetrics and Gynaecologists Societies in India 2006. Contraception: Past, Present and Future: 2006. India. United Nations Population Fund.(2006). Contraceptive Updates: 2006.[Online].[Accessed on 16 April2013]. Available from:http://mohfw.nic.in/NRHM/FP/ reference_material.pdf 5. USAID and Family Health International, 360. Facts for family Planning. [Online].[Accessed on 15 April 2013]. Available from: http://www.fphandbook.org/sites/default/files/familyplanning_web. pdf 6. WHO/USAID and Johns Hopkins (2011) Family Planning: Global hand book,revised 2011 update. Geneva, Switzerland: WHO Press. 7. Government of India: Standards for Sterlisation, Quality Assurance, Intra Uterine Devices, Minilap and NSV. 8. Family Planning Association of India. Injectable Contraceptives: Technical Guide for Service providers: 9. Population Services International.2012. Intrauterine Uterine Devices: Reference Manual for Doctors. India. 10. Smith R., L. Ashford., J. Gribble and D. Clifton. 2012. Family planning saves lives. PopulationReference Bureau. 4th ed.Washington. 11. United Nations Population Fund.2013.Gender Biased sex selection and Access to safe abortion. IPAS and UNFPA publication. 12. Trends and Differentials in fertility and FP indicators of EAG states in India : A policy paper from Policy project 2012. 13. United Nations Population Fund.2009.Doctors for daughters: An information kit for Doctors on PC-PNDT Act 2009.[online].[Accessed on 20 April 2013]. Available from:http://india.unfpa. org/?publications
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Annexure 2 Infection Prevention in the Clinics/facilities Infection prevention procedures are simple, safe, effective and inexpensive. infectious organisms of concern in the clinics include bacteria (such as staphylococcus), viruses (particularly HIV and Hepatitis B and Hepatitis C), fungi and parasites. In the clinic, infectious organisms can be found in blood and body fluids with visible blood or tissue. The organisms can be passed through mucous membranes or broken skin, such as cuts and scratches and by needlesticks with used needles and other puncture wounds. Infectious organisms can pass from clinics to communities when waste disposal is not proper or staff members do not wash their hands properly before leaving the clinic. Basic Rules of Infection Prevention: These rules are to apply the universal standard precautions for infection prevention for all hosital procedures at all times with all clients to decrease the risk of transmission of infection, including the Human Immunodeficiency Virus (HIV), Hepatitis C (HCV), and Hepatitis B (HBV). Standard universal precautions of infection prevention include: Washing hands 1. Ensuring self-protection by wearing gloves and employing other physical barriers 2. Adopting safe work practices (to prevent injuries from sharps/instruments) 3. Maintaining proper methods of environmental cleanliness 4. Ensuring the proper processing of instruments and other reusable items 5. Following proper waste-disposal practices and handling, transporting, and processing used and/ or soiled linens in the recommended and prescribed manner. Hand Washing yy Hand washing may be the single most important infection prevention procedure. yy Wash hands before and after examining or treating each client. (Hand wasing is not necessary if clients do not require an examination or treatment.) yy Use clean water and plain soap, and rub hands for at least 10 to 15 seconds. Be sure to follow six steps of hand washing to clean thumbs, tips of fingers, between the fingers and under fingernails, back of the hand and wrists. yy Wash hands after: »»
arriving for work
»»
handling soiled instruments and other items
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touching mucous membranes, blood, or other body fluids
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before putting on gloves and after removing gloves
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»»
before and after eating food
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after you use the toilet or latrine
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when you leave
Dry hands with a paper towel or a clean, dry cloth towel that no one else uses, or air-dry. Practices such as using a common basin where a number of people or even one person washes or dips his/her hand(s) repeatedly is dangerous and must be abandoned.
Surgical scrub a) The surgeon and his/her assistant must scrub both their hands and forearms up to the elbows thoroughly with soap and running water or antiseptic agents. The entire procedure should be repeated at least three times so that the scrub lasts for at least 3 minutes. The hands and forearms should be air dried. Do not dry hands with sterile surgical gown which you are going to wear for surgical procedure. b) A small nail brush should be used for cleaning fingernails.
Ideally, the surgeon and the assistant should scrub thoroughly between each procedure. In camp settings, in order to prevent re-colonization of the skin by micro-organisms, the surgical staff should do a three-minute surgical scrub every hour or after every five cases (whichever is earlier) or if the surgeon (and/or the surgical staff) goes out of the operation theatre (OT), or touches any infected item or if the glove is torn. In between antiseptic alcohol scrub should be done. Six steps of effective hand wash 1. Wash palms & fingers
4. Wash finger tips
2. Wash back of hands
3. Wash fingers & interdigital space
5. Wash thumbs
6. Wash wrists
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Process instruments that touch tissues beneath the skin,and will be re-used, preferably after sterilization or high level disinfection. Do the following: yy Wear gloves for any procedure that risks touching blood, other body fluids, mucous membranes, broken skin, soiled items, dirty surfaces or waste yy Wear sterilized surgical gloves for surgical procedures such as insertion of implants yy Wear single use examination gloves for procedures that touch intact mucous membranes or generally to avoid exposure to body fluids yy Gloves are not necessary for giving intramuscular injections yy Change gloves between procedures on the same client and between clients yy Do not touch clean equipment or surfaces with dirty gloves or bare hands yy Wash hands before putting on and after removing gloves. Put gloved hand in 0.5% chlorione solution before removing them. Do not wash gloved hands instead of changing gloves. Gloves are not a substitute for hand washing yy Wear clean utility gloves when cleaning soiled instruments and equipment, handling waste and cleaning blood or body fluid spills Do Pelvic Examination only when needed Pelvic examinations are not needed for most family planning methods- needed only for female sterilization and the IUD. Pelvic examinations should be done only when there is a reason â&#x20AC;&#x201C; such as suspicion of sexually transmitted infections, when the examination could help with diagnosis or treatment. For injections, use new auto disable syringes and needles Auto disable syringes and needles are safer and more reliable than standard single use disposable syringes and needles and any disposable syringes and needles are safer than sterilizing re-usable syringes and needles. Reusable syringes and needles should be considered only when single use injection equipment is not available and if programmes can document the quality of high level disinfection (HLD)/sterilization Cleaning the clientâ&#x20AC;&#x2122;s skin before the injection is needed when the skin is dirty. If it is washed with soap and water with a clean towel. Wiping with an antiseptic has no added benefit. Asepsis in OT/Procedure room/client care area Wipe examination tables, bench tops, and other surfaces that come in contact with unbroken skin with 0.5% chlorine solution after each client. A. Before Surgery yy Clean the operating table, table/counter top and light handles with a cloth soaked in 0.5% chlorine solution and detergent
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yy Clean the floor with a mop soaked in 0.5% chlorine solution B. After Surgery yy Decontaminate all operating room surfaces that come into contact with the patient (such as table) between procedures by scrubbing and wiping them with 0.5% chlorine solution yy The operating table, counters/table tops, and light handles should be wiped with a detergent and 0.5% chlorine solution Dispose of single use equipment and supplies properly and safely Handling bio-medical waste yy Use personal protective equipment – googles, mask , apron and closed protective plastic shoes when handling wastes. yy Needles and syringes meant for single use must not be reused. Do not take apart the needle and syringe. Used needles should not be broken, bent or recapped. Put used needles and syringes immediately into a puncture proof container for disposal. (If needles and syringes will not be incinerated , they should be decontaminated by flushing with 0.5% chlorine solution before they are put into the puncture – proof container).The puncture proof sharps container should be sealed and deeply buried when three–fourths full. yy Dressings and other soiled solid waste should be collected in plastic bags and, within 2 days, buried in a deep pit. Liquid wastes should be poured down a utility sink drain or a flushable toilet or poured into a deep pit and buried. yy Clean waste containers with detergent and rinse with water. yy Remove utility gloves and decontaminate and clean them whenever they are dirty and at least once every day. yy Wash hands before putting on and after removing utility gloves for disposing of soiled equipment and waste. Wash Linens Wash linens (for example bedding, caps, gowns, and surgical drapess) by hand or machine and line dry or machine dry. When handling soiled linens, wear gloves and other protective attire , hold linens away from your body and do not shake them. Little risk of HIV Infection in the clinic yy Health care providers may be exposed to HIV through needle sticks, mucous membranes , or broken skin, but the risk of infection is low. yy Needle sticks or cuts cause most infections in health care settings. The average risk of HIV infection after a needle stick exposure to HIV infected blood is 3 infections per 1,000 needle sticks but risk of Hep. B infection is 10% to 30 % and Hep. C risk of infection is 3% to 10% .
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yy The risk after exposure of the eye, nose or mouth to HIV infected blood is estimated to be about 1 infection per 1,000 exposures. A small amount of 0.00000001 CC of blood is sufficient to infect. yy Following universal precautions is the best way that providers can avoid workplace exposure to HIV and other fluid borne infections. Make Infection Prevention a Habit With each and every client and each and every procedure on a client, a health care provider should think, “ What infection prevention procedure is needed? “Any client or provider may have an infection without knowing it and without obvious symptoms. Infection prevention is a sign of good health care that can attract clients. For some clients cleanliness is one of the most important signs of quality. The 4 steps of processing reusable equipment are yy Decontaminate to kill infectious organisms such as HIV and Hepatitis B and C and to make instruments, gloves, and other objects safer for people who clean them. Soak in 0.5% chlorine solution for 10 minutes. Rinse with clean water or clean immediately. yy Clean to remove body fluids, tissue and dirt. Wash or scrub with a brush ( a toothbrush is a good option) with detergent and water. Avoid bar soap or powdered soap, which form a sticky substance with blood and body tissues and can stay on the equipment. Rinse and dry. While cleaning, wear utility gloves and personal protective equipment- goggles, mask, apron and enclosed shoes. yy High level disinfection or sterilization »»
High level disinfection kills all infectious organisms except some bacterial endospores (a dormant, resistant form of bacteria) by boiling, steaming or with chemicals. Instruments or supplies that touch intact mucous membranes or broken skin, such as vaginal specula, uterine sounds and gloves for pelvic examinations should be high level disinfected or sterilized. Sterilization is the preferred method while HLD is an acceptable alternative. HLD can be achieved either by boiling or by soaking in a high-level disinfectant (like 2% glutaraldehyde) for 20 minutes.
»»
Sterilization kills all infectious organisms including bacterial endospores, with a high pressure steam autooclave, a dry heat oven, chemicals, or radiation. It can be done by using steam (autoclaving) at 15lb pressure for 30 minutes or soaking in a chemical solution (2% gluteradehyde) for 10 hours.
»»
Store instruments and supplies to protect them from contamination. They should be stored in a dry high level disinfected or sterilized container in a clean area away from clinic traffic. The equipment used to sterilize and high level disinfect instruments and supplies also must be gaurded against contamination.
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Some procedures/equipment which are ineffective and obselete ( which may still be used at clinics/ hospitals) are: yy Fumigation of OT yy Using Ultravoilet lamps for asepsis in OT yy Flaming of trays with spirit to sterilize instrument tray yy Putting instruments in formaline chamber for sterilization
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Annexure 3 FORM F [See Proviso to Section 4(3), Rule 9(4) and Rule 10(1A)] Form for Maintenance of Record in Respect of Pregnant Woman by Genetic Clinic/Ultrasound Clinic/Imaging Centre 1. Name and address of the Genetic Clinic/Ultrasound Clinic/Imaging Centre. 2. Registration No. 3. Patient’s name and her age. 4. Number of children with sex of each child. 5. Husband’s/Father’s name. 6. Full address with Tel. No., if any. 7. Referred by (full name and address of Doctor(s)/Genetic Counseling Centre (Referral note to be preserved carefully with case papers)/self-referral. 8. Last menstrual period/weeks of pregnancy. 9. History of genetic/medical disease in the family (specify).
Basis of diagnosis: (a) Clinical (b) Bio-chemical (c) Cytogenetic (d) Other (e.g. Radiological, ultrasonography etc. specify).
10. Indication for pre-natal diagnosis. A. Previous child/children with:
Chromosomal disorders metabolic disorders Congenital anomaly Single gene disorder
Mental retardation Haemoglobinopathy Sex linked disorders. Any other (specify)
B. Advanced maternal age (35 years). C. Mother/father/sibling has genetic disease (specify). D. Other (specify). 11. Procedures carried out (with name and registration No. of Gynaecologist/Radiologist/Registered
Medical Practitioner) who performed it. …………………………………………………………………………
Non-Invasive
(i) Ultrasound ………………………………………………………………………………………………………
(Specify purpose for which ultrasound is to done during pregnancy)
[List of indications for ultrasonography of pregnant women are given in the important Notes]
Invasive
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Amniocentesis Chorionic Villi aspiration Foetal biopsy Cordocentesis. Any other (specify).
12. Any complication of procedure – please specify. 13. Laboratory tests recommended [Strike out whichever is not applicable or not necessary]
Chromosomal studies Biochemical studies.
Molecular studies Pre-implantation genetic diagnosis.
14. Result of
(a) Pre-natal diagnostic procedure (give details)…………………………………………………………………….
(b) Ultrasonography Normal/Abnormal
(Specify abnormality detected, if any)
15. Date(s) on which procedures carried out. 16. Date on which consent obtained. (In case of invasive). 17. The result of pre-natal diagnostic procedure was conveyed to ….………………..….on …………….……… 18. Was MTP advised/conducted? 19. Date on which MTP carried out
Date: Name, Signature and Registration number of the
Place Gynaecologist/Radiologist/Director of the Clinic.
Declaration of Pregnant Woman I, Ms. ________________ (name of the pregnant woman) declare that by undergoing ultrasonography /image scanning etc. I do not want to know the sex of my foetus.
Signature/Thumb impression of pregnant woman
Declaration of Doctor/Person Conducting Ultrasonography/Image Scanning
I, __________________ (name of the person conducting Ultrasonography/image scanning) declare that while conducting ultrasonography/image scanning on Ms. ___________ (name of the pregnant woman), I have neither detected nor disclosed the sex of her foetus to anybody in any manner.
Name and signature of the person conducting Ultrasonography/image scanning/Director or owner of genetic clinic/ultrasound clinic/imaging centre.
Important Note:(i) Ultrasound is not indicated/advised/performed to determine the sex of foetus except for diagnosis of sex-linked diseases such as Duchenne Muscular Dystrophy, Haemophilia A & B etc. (ii) During pregnancy Ultrasonography should only be performed when indicated. 157
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The following is the representative list of indications for ultrasound during pregnancy. 1) To diagnose intra-uterine and/or ectopic pregnancy and confirm viability. 2) Estimation of gestational age (dating). 3) Detection of number of fetuses and their chorionicity. 4) Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive failure/ MTP failure. 5) Vaginal bleeding / leaking. 6) Follow-up of cases of abortion. 7) Assessment of cervical canal and diameter of internal os. 8) Discrepancy between uterine size and period of amenorrhoea. 9) Any suspected adenexal or uterine pathology / abnormality. 10) Detection of chromosomal abnormalities, foetal structural defects and other abnormalities and their follow-up. 11) To evaluate foetal presentation and position. 12) Assessment of liquor amnii. 13) Preterm labour / preterm premature rupture of membranes. 14) Evaluation of placental position, thickness, grading and abnormalities (placenta praevia, retroplacental haemorrhage, abnormal adherence etc.). 15) Evaluation of umbilical cord â&#x20AC;&#x201C; presentation, insertion, nuchal encirclement, number of vessels and presence of true knot. 16) Evaluation of previous Caesarean Section scars. 17) Evaluation of foetal growth parameters, foetal weight and foetal well being. 18) Colour flow mapping and duplex Doppler studies. 19) Ultrasound guided procedures such as medical termination of pregnancy, external cephalic version etc. and their follow-up. 20) Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus sampling (CVS), amniocenteses, foetal blood sampling, foetal skin biopsy, amnioinfusion, intrauterine infusion, placement of shunts etc. 21) Observation of intra-partum events. 22) Medical/surgical conditions complicating pregnancy. 23) Research/scientific studies in recognized institutions. Person conducting ultrasonography on pregnant women shall keep complete record thereof in the clinic/centre in Form â&#x20AC;&#x201C; F and any deficiency or inaccuracy found therein shall amount to contravention of provisions of section 5 or section 6 of the Act, unless contrary is proved by the person conducting such ultrasonography.
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Annexure 4 MTP Consent Form Form C (Refer rule 9 MTP, 2003)
I______________________________________________Daughter/Wife of ______________________aged about_________ years at present residing at _____________________________do hereby give my consent to termination of my pregnancy at ________________________________________________
Place __________________
Signature
Date __________________
(To be filled in by guardian where the woman is a mentally ill person or a minor
I _____________________________Son/Daughter/wife of ______________________aged about_________years at present residing at ___________________________________________________________ give my consent to the termination of the pregnancy of my ward __________________________who is a minor/ mentally ill person at _____________________________________________________________
Place_____________
Signature
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Annexure 5 Client Card for Medical Method of Aborton In case of emergency, please contact: Doctor:___________________________________________________
Phone Number: _________________________
Hospital Address:_______________________________________________________________________________________ _________________________________________________________________________________________________________
Details of the Patient: Name:________________________________________________________Phone Number:__________________________ Residential Address: ___________________________________________________________________________________ _________________________________________________________________________________________________________ Date of visit:__________________________________ Date of second visit:_____________________________________ Date of third visit:_________________________________________________
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Annexure 6 Gender Biased Sex-Selection and Access to Safe Abortions Frequently Asked Questions The declining child sex ratio Recent census (2011) data reveal a dismal child sex ratio of 914 females per 1000 males. This is down from 927 in 2001; and 945 in 1991. However, the Sex ratio at birth at the national level increased from 892 in 2000-2002 to 906 in 2007-2009 though this is still a far cry from normal sex ratio at birth. Gender biased sex selection in favour of boys is a symptom of pervasive social, cultural, political and economic injustices against women, and a manifest action of gender discrimination. In recent times, it has been perpetuated by the illegal use of diagnostic technologies coupled with unethical medical practices. Such injustices must be addressed and resolved without exposing women and children to the risk of death or serious injury through denying them access to needed services â&#x20AC;&#x201C; and thus further violating their rights (Dickens et al, 2005). The Pre-natal Diagnostic Techniques Regulations and Prevention of Misuse Act came into force in 1994 to curb selective sex determination. With rapid improvements in diagnostic technology the Act was amended in 2003 to make it more comprehensive and was renamed the Preconception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act. While the Act can be successful in hindering any further worsening of the gender imbalancei, there are challenges in its effective implementation. Policy makers and programme managers at national, state and district levels are seriously concerned with the decline in the child sex ration and grappling with solutions to arrest this decline. Unsafe Abortions: A continuing problem Forty years ago, the Medical Termination of Pregnancy Act (1971) entitled women in India access to abortion services under certain specified conditions. However, it is a well-documented fact that abortions are not available to millions of women in India who need them. It is estimated that 6.4 million abortions take place in India each year. Half of these (around 3.6 million) are unsafe â&#x20AC;&#x201C; performed in unhygienic conditions by untrained providersii. More than 80 percent of women in the country still do not know that abortion is legal and availableiii. Add to this the fact that abortion is highly stigmatized in the socio-cultural context, leading many women who seek an abortion to visit unsafe backstreet providers. Unsafe abortion is the third leading cause of maternal deaths in India, contributing to eight percent of all maternal deaths annually - morbidity attributable to unsafe abortions is much more. Inter-linkages Though the reasons for the skewed sex ratio stem from multiple deep-rooted social and cultural issues, the most common reason given to explain it is the purported easy availability of ultrasound technologies and abortions in the country. This is a flawed assumption precisely because sex selection is first about determination of the sex of the fetus At times, an instant reaction based on a flawed understanding leads to restrictions on access to second trimester abortions, seen as an easy solution to fix the problem of sex selection. This already has and will continue to have unfortunate side-effects: in some cases, attempts to combat gender biased sex selection have made it more difficult for all women to access abortion. Many women who seek abortions in India do so through backstreet practitioners. Administrative action that puts curbs on abortion will
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tend to further drive women to unsafe services as already being seen in some states and a woman who requires an abortion in the second trimester for whatever reason may be assumed to be guilty of asking to terminate the pregnancy for sex-selection reasons. Given the current environment and ad-hoc measures to curb gender biased sex selection, there is always a threat of restriction to the womenâ&#x20AC;&#x2122;s access to abortion, especially second trimester abortion in India. Various United Nations human rights treaty monitoring bodies have established that the rights of women and girls to life, health and development are violated when they undergo an unsafe abortion because safe services are denied to them. Ensuring access to services for safe abortion to the full extent of the law at all times is crucial, as is working with communities to address the social norms and practices that increase the vulnerability of women and girls to the health risks associated with unsafe abortions. It can be challenging for policymakers to envision approaches that simultaneously address the serious issue of gender biased sex selection while protecting womenâ&#x20AC;&#x2122;s access to safe, legal abortion services. Below are responses to some frequently asked questions that attempt to clarify the differences between the two issues and provide helpful information to states across the country that are attempting to address the two issues with equal regard for their importance to the lives of women and girls.
Q. What is ultrasonography (USG) used for during pregnancy?
Ultrasonography for pregnant women is conducted to monitor fetal health and for specific maternal conditions like bleeding or excessive pain. In the first trimester of pregnancy, USG helps to diagnose and determine the viability of the pregnancy. In the second trimester, it helps to identify congenital abnormalities in the fetus. It is also in the second trimester, that the sex of the fetus can be determined through ultrasonography. However, the use of ultrasonography for non-medical reasons such as to determine the sex of the fetus is not permitted under law.
Q. Is increased availability of USG the only reason for gender biased sex selection?
No. While studies point to a link between higher availability of sonography centres and a decline in child sex ratio. it will be wrong to solely associate the increasing availability of USG to the increase in sex selection. Technology itself has its positives and USG has played an important role in improving maternal and newborn health outcomes across the country. Analysis of the National Family Health Survey (NFHS-3) data shows that among women who had at least one USG for any of their pregnancies, 80 percent had one or more live births without any pregnancy lossiv. Equally, it is the misuse of technology by the medical community that has made it possible for parents to act out their preference for sons.
Q. Is pre natal sex-selection the only reason for the skewed child sex ratio?
No. The main reason for skewed child sex ratio is son preference â&#x20AC;&#x201C; this manifests itself not only in the prenatal period but in practices that discriminate against females even after birth. Girls killed shortly after birth or adopted outside the family are sometimes unaccounted for. Discriminatory feeding and health care practices leading to neglect cause an increase in post-natal mortality in girls which is visible in the gender gap in infant and under five mortality rates of some states. The ratio can be also affected by the under counting of girls in census enumerationsv.
Q. Do women seek abortions only to terminate a pregnancy when the fetus is female?
No. Most women who opt for an abortion do so because they cannot afford another child, because contraception has failed, because they are unmarried, or because they have been raped. Estimates indicate that two to four percent of all abortions in the country are son selective abortionsvi. According to estimates for 2001-2008, 4.6 percent of all female births did not occur because of pre- natal sex selection. (UNFPA; Trends in SRB and estimates of girls missing at birth in India, 2011) .
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Q. What makes an abortion legal in India?
Abortion is legal if it fulfills the following conditions:
»»
Performed by a registered medical practitioner as defined in the MTP Act.
»»
Performed in a place approved under the Act.
»»
Other requirements such as gestation period, consent and opinion of registered medical practitioners are fulfilled.
In India many private providers, including well-qualified private providers, may provide safe abortion services, although the fact that facilities where they perform abortion are not approved makes them illegal. Therefore, facilities capable of providing safe abortion services need to be able to get a registration under the MTP act in a timely and a systematic matter. It is only when access to safe abortion improves that woman will not need to resort to backstreet and unsafe services.
Q. What are the legal requirements for offering abortion services? »»
The MTP Act clearly spells out requirements in order to provide legal and safe abortion services.
»»
The Act lays out the qualifications for providers who wish to offer abortion services.
»»
The Act also spells out facility requirements for clinics that wish to be eligible for approval to offer abortion services in the first and second trimesters.
»»
For second trimester abortions opinion of two registered medical practitioners as defined in the Act is mandatory.
Q. Is sex-selective abortion illegal under the MTP Act?
Yes. Sex determination is not a permitted condition for seeking legal abortion under the MTP Act. Under the MTP Act abortion in India is legal for the following conditions: »»
When continuation of a pregnancy involves risk to the life of the pregnant woman or of grave injury to her physical or mental health taking into account the pregnant woman’s actual or reasonable foreseeable environment.
»»
When there is substantial risk that if the child were born, s/he would suffer from such physical or mental abnormalities as to be seriously handicapped.
»»
In cases of rape.
»»
When the device or method used by any married woman or her husband for the purpose of limiting the number of children has failed.
Q. Are all second-trimester abortions sex selective? Why do women seek abortions in the second trimester?
Not all second-trimester abortions are sex selective. In fact, while sex determination takes place mostly in the second trimester of pregnancy, 80 to 90 percent of reported abortions in India take place in the first trimester.
In India, some women delay pregnancy termination until they are in the second trimester of pregnancy for reasons other than sex selection. Cases of delay in abortion seeking are common amongst poor, young, and unmarried women in particular, who are often poorly informed on many fronts: they may not understand the signs of pregnancy, the possibility or legality of obtaining an abortion, the importance of seeking early abortion (in the first trimester) and the location of safe services.
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Q. What can be the consequences of restricting access to abortions for women?
Restriction on safe abortion services will have long-term consequences on the health of women – especially if they are poor and less educated – and may also violate their human and reproductive health rights (Ganatra 2008). Evidence shows that if women do not have access to safe abortion services they often turn to unsafe options (WHO, 2007). Placing limitations on second-trimester abortions and/or increasing unnecessary reporting requirements for abortions will discourage providers from offering abortion services. Any immediate actions to curb access to abortions by government will add to the already widespread belief that abortion in India is illegal, pushing women to risk their lives, when they are in need of early and safe abortion services.
Q. What are some steps that can lead to a balanced approach to address both issues of sex selection and lack of access to abortions? »»
Educating policymakers, government officials and other stakeholders on the ways in which both MTP and PCPNDT Acts are implemented in fulfilling their intents, that is to prevent unsafe abortion and to prevent sex selection respectively. Using one law to fulfill the intent of the other is in fact counterproductive and does not help fulfill the objectives of both Acts.
»»
Encouraging dialogue among the NGOs that work to implement the PCPNDT Act and the MTP Act to reach consensus on strategies that address both issues without hindering either; and to ensure strengthened implementation of both Acts with clear understanding of the intent of each.
»»
Operationalizing District Level Committees under the MTP Act so that private abortion providers are brought into the legal framework of the MTP Act. This will ensure regular reporting of MTP cases, including second-trimester abortions.
»»
Focussing communication campaigns on the issue of sex determination and selection.
»»
Clearing up public misconceptions by emphasizing that sex determination is illegal, while abortion is legal (for certain conditions) in the country.
»»
Using communication campaigns to emphasize the importance of seeking early and safe abortion, in order to discourage abortions in the second trimester when chances of sex selection are higher.
»»
Ensuring better regulation and vigilance to stem illegal and unethical practices instead of imposing additional restrictions such as not allowing sale of abortion drugs or redistricting on registration of facilities for MTP.
»»
Supporting implementation of programmes and initiatives that seek to reduce gender discrimination.
»»
Seeking and implementing behavior-change campaigns to address the underlying social causes of sex selection and discrimination against the female child.
Q. How can improved implementation of the MTP Act prevent sex-selective abortions?
The MTP Act clearly defines the approval requirements for private-sector facilities and reporting mechanisms for both public- and private-sector facilities. However, implementation of the MTP Act is poor across the country, and data for abortion services is often missing in both the public and private sectors. Improved implementation of the MTP Act will contribute to better reporting of cases of abortion in the country and provide information on trends of abortion, the gestational age at which abortions are sought, and number and location of private-sector facilities offering abortions. This will lead to improved access to safe, legal abortion services for conditions approved by the Act and will make realistic data available for better analysis and policymaking.
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Q. What steps can be taken to improve implementation of the MTP Act?
Some steps that can be urgently taken to improve the implementation of MTP Act include:
»»
Setting up of the district-level MTP committees
»»
Putting in place systematic inspection of facilities and monitoring of MTP records
»»
Expediting registration of facilities that fulfill the criteria set under the Act to qualify for providing MTP services
Gender biased sex selection further undervalues women and girls, it perpetuates gender discrimination and should be addressed through effective enforcement of the PC-PNDT Act as well as other actions required to promote the value of girls and overall gender equality. However, we must ensure that in doing so, women’s right to safe abortion services is not compromised in any manner.
i Arindam Nandi & Anil Deolalikar. Does a Legal Ban on Sex Selective Abortions Improve Child Sex Ratios? Evidence from a Policy Change in India, April 2011. Accessed online at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1824420&http://papers.ssrn. com/sol3/papers.cfm?abstract_id=1824420 ii Duggal R, Ramachandran V. The Abortion Assessment Project-India; Key Findings and Recommendations. Reproductive Health Matters, Volume 12, Issue 24, 2004. 122-129 iii Banerjee et al. 2009.Knowledge and Care seeking behavior in four selected districts of Bihar and Jharkhand. India. Presented at Population Association of America (PAA). April-May 2009. Available online at paa2009.princeton.edu/sessionViewer. aspx?SessionId=153
Banerjee et al. 2011.Understanding the Role of Ultrasound (USG) in improving maternal care in India
iv
Jha P. et al. Trends in selective abortion of girls: Analysis of nationally representative birth histories from 1990 to 2005 and census data from 1991 to 2011. Published online May 24, 2011 www.thelancet.com v
Ibid
vi
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Annexure 7 Chart on Effectiveness of contraceptives
Source - Family Planning - A Global Handbook for Provider - Revised 2011 update
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Annexure 8 WHO statement on hormonal contraception and bone health (http://whqlibdoc.who.int/wer/WHO_WER_2005/80_297-304(no35).pdf) Steroid hormonal contraceptives, including oral contraceptives, injectables and implants, are highly effective and widely used. These contraceptives have important health benefits, including contraceptive and non-contraceptive benefits, and some health risks. For most women, the health benefits of use clearly exceed the health risks. Questions have been raised regarding the association between use of one particular hormonal contraceptive, depomedroxy-progesterone acetate (DMPA), and the risk of bone loss. In response, WHO convened a consultation in Geneva, Switzerland, on 20â&#x20AC;&#x201C;21 June 2005, to assess current evidence on the relationship between the use of steroid hormonal contraceptives and bone health. Bone health may be influenced by many factors including pregnancy, breastfeeding and use of hormonal contraceptives. The principal clinical outcome of interest with regard to bone health is the occurrence of fracture. Bone mineral density (BMD) measurements are commonly used to assessfracture risk, but the accuracy of measurements can be influencedby changes in body composition, including changes in lean body mass and fat. Furthermore, fracture risk is related to many factors, BMD being only one of them. The relationship between decrease in BMD and increase in fracture risk has been best studied in postmenopausal women, among whom the risk of any fracture increases approximately 1.5- fold for each standard deviation decrease in BMD. There is little information on the impact of BMD changes in young age groups on fracture risk later in life. Progestogen-only methods of contraception With regard to Progestogen-only methods, data on Levonorgestrol implants suggest no adverse effect on BMD. Other low-dose Progestogen-only contraceptives such as pills, other implants and the Levonorgestrol-releasing intrauterine device do not appear to have an effect on BMD, although data for these methods are limited. The use of DMPA for contraception produces a hypo-estrogenic state in women; some studies have shown that this is associated with a decrease in BMD. The weight of data indicates that DMPA use reduces BMD in women who have attained peak bone mass, and impairs the acquisition of bone mineral among those who have not yet attained peak bone mass. The magnitude of the effect on BMD is similar across a variety of studies. Cross-sectional studies show lower BMD in longer-term DMPA users by approximately 0.5 standard deviation at the hip and spine compared with non-users. In longitudinal studies, adults (18 years) and adolescents (menarche to<18 years) both lost around 5â&#x20AC;&#x201C;7% (approximately 0.5 standard deviation) of BMD at the same sites, after 2 years of continuous use of DMPA. The rate of loss appeared to decrease over time. When DMPA use is discontinued, BMD increases again in women, regardless of age, except for those who have reached menopause. Among adults, BMD values appear to return tothose of comparable nonDMPA users over a period of 2 to 3 years. It is not clear whether the loss in BMD among adolescent users of DMPA prevents attainment of potential peak bone mass. There remains a concern that older women who reach the menopause while still using DMPA may no longer have the opportunity to regain BMD before entering the period of bone loss normally associated with menopause. Absolute fracture risk is low during the reproductive years, and insufficient data exist to assess whether DMPA use modifies this risk. There are also insufficient data to assess whether DMPA use during
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the reproductive years affects the risk of fracture in future postmenopausal life. Since the effect on BMD is largely reversible, any lifetime increase infracture risk is likely to be small. Data regarding the use of the other Progestogen-only injectable contraceptive, NorethisteroneEnanthate (NETEN), are insufficient to determine whether there is any effect of NET-EN on bone health. In the absence of evidence, the concerns regarding DMPA and bone health also apply to NET-EN. DMPA is a highly effective and widely available method of contraception, which plays an important role in the contraceptive method mix. This is particularly so in regions with a high unmet need for contraception and where maternal morbidity and mortality are high. Any decisions regarding choice of a contraceptive method should also take this fact into consideration. WHO will continue to monitor research in this area and will review the recommendations listed below as and when new evidence becomes available. WHO also encourages relevant research in this area to fill key evidence gaps. Recommendations, with regard to bone metabolism yy There should be no restriction on the use of DMPA, including no restriction on duration of use, among women aged 18 to 45 years who are otherwise eligible to use the method. yy Among adolescents (menarche to <18 years) and women over 45 years, the advantages of using DMPA generally outweigh the theoretical safety concerns regarding fracture risk. Since data are insufficient to determine if this is the case with long-term use among these age groups, the overall risks and benefits for continuing use of the method should be reconsidered over time with the individual user. yy Recommendations regarding DMPA use also pertain to use of NET-EN. There should be no restriction on the use of other Progestogen- only contraceptive methods among women otherwise eligible to use these methods, including no restrictions on duration of use. yy There should be no restriction on the use of combined hormonal contraceptive methods among women who are otherwise eligible to use these methods, including no restrictions on duration of use.
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Annexure 9 FOGSI Policy Statement - Injectable Contraception - September 2003 yy FOGSI confirms the WHO Guidelines and believes that injectable hormonal contraceptives are a safe, effective and convenient form of contraception particularly for lactating and oestrogen sensitive women. yy Extensive trials have proven that the method is reversible with additional health benefits. yy Proper counselling regarding menstrual irregularity will improve the compliance. yy FOGSI advises its members to use injectable hormonal contraceptives within the WHO Guidelines.
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Annexure 10 Criteria for Empanelment of a Doctor /Accreditation of a Health Facility for Sterilization Physical Infrastructure Standards for physical infrastructure for static services have been laid down in the documents Standards for Male and Female Sterilization and Standard Operating Procedures (SOP) on Camps/ Mobile Services, which provide details about input, requirements, and processes for camps. These documents can be accessed from the Research Studies & Standards (RSS) Division of the Ministry of Health and Family Welfare (MOHFW), Government of India or from the MOHFW website (www. mohfw.nic.in) Processes The processes include technical and interpersonal dimensions and encompass a range of elements. The protocols for the following procedures are detailed in the Standards for Male and Female Sterilization, 2006. yy Counselling yy Minilaptubectomy yy Laparoscopic tubectomy yy Conventional vasectomy yy No-scalpel vasectomy yy Anaesthesia/analgesia/premedication yy Follow-up protocols yy Infection-prevention practices Complications All cases of failure and complications, major or minor, arising during surgery or post-surgery must be documented and a copy sent to the district QAC. The major complications that required hospitalization and all cases of failure must be reported to the district QAC. The district QAC will in turn be responsible for communicating such information to the concerned insurance service providers for compensation.
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Personnel Requirement Female Sterilization 1. One MBBS Doctor trained to carry out MinilapTubectomy OR
One Gynaecologist with DGO/MD/MS qualification or
A surgeon with MS Degree and trained in Laparoscopic sterilization.
Male Sterilization 1. One MBBS doctor trained in Vasectomy 2. One Staff Nurse LHV/ ANM / 3. One OT Assistant / Helper 4. One Male worker for counseling and administrative work
2. One OT Staff Nurse/ LHV/ ANM 3. One OT Assistant/ Helper 4. One Anaesthetist â&#x20AC;&#x201C; can be hired if necessary.
Infrastructure requirement Female Sterilization Facilities
Male Sterilization
yy
Well ventilated, fly proof room with concrete/tiled floor which can be cleaned thoroughly
yy
Well ventilated, fly proof room with concrete/tiled floor which can be cleaned thoroughly
yy
Running water supply through tapor bucket with tap
yy
Running water supply through tapor bucket with tap
yy
Electricity supply with a stand by generator and other light source necessary.
yy
Electricity supply with a stand by generator and other light source.
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Female Sterilization Space required
Male Sterilization
yy
Area for reception
yy
Area for reception
yy
Waiting area
yy
Waiting area
yy
Counselling area which offers privacy and ensures avoidance of any interruptions.
yy
Counseling area which offers privacy and ensures avoidance of any interruptions.
yy
yy
Laboratory for blood & urine examination
Laboratory for blood & urine examination
yy
Clinical examination room for initial assessment and follow up
yy
Pre-operative preparation room for trimming of hair, washing,changing of clothes and premedication
yy
Hand washing area near the OT for scrubbing
yy
Sterilization room, near the OT for autoclaving, washing and cleaning equipment,preparation of sterile packs.
yy
Operation theatre should be isolated and away from the general thoroughfare of the clinic, if should be large enough to allow operating staff to move freely and to accommodate all the necessary equipment. Lighting should be adequate.
yy
Recovery room must be spacious and well ventilated,number of beds will be determined by the available space, should be adjacent to the OT
yy
Adequate number of toilets: sufficient number of sanitary type toilets with running water for the clients and the staff.
yy
Storage area
yy
Office area for keeping records
yy
Clinical examination room for initial assessment and follow up
yy
Pre-operative preparation room fort rimming of hair, washing, changing of clothes and premedication
yy
Hand washing area near the OT for scrubbing
yy
Sterilization room, near the OT for autoclaving, washing and cleaning equipment, preparation of sterile packs.
yy
Operation theatre should be isolated and away from the general thorough fare of the clinic, if should be large enough to allow operating staff to move freely and to accommodate all the necessary equipment. Lighting should be adequate.
yy
Recovery room must be spacious and well ventilated, number of beds will be determined by the available space,should be adjacent to the OT
yy
Adequate number of toilets: sufficient number of sanitary type toilets with running water for the clients and the staff.
yy
Storage area
yy
Office area for keeping records
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Female Sterilization Examination room requirement
Laboratory
Sterilization room
Cleaning Room
Male Sterilization
yy
Examination table
yy
Examination table
yy
Foot stool
yy
Foot stool
yy
Blood Pressure apparatus
yy
Blood Pressure apparatus
yy
Thermometer
yy
Thermometer
yy
Stethoscope
yy
Stethoscope
yy
Examination light
yy
Weighing scale
yy
Instrument for pelvic examination
yy
Haemoglobinometer and accessories
yy
Haemoglobinometer and accessories
yy
Apparatus to estimate albumin and sugar in urine
yy
Apparatus to estimate albumin and sugar in urine
yy
Reagents
yy
Reagents
yy
Autoclave
yy
Autoclave
yy
Boiler
yy
Boiler
yy
Surgical drums
yy
Autoclave drums
yy
SS Tray
yy
Glutaraldehyde Solution 2%
yy
Glutaraldehyde solution 2%
yy
Hand Brushes
yy
Hand Brushes
yy
Utility gloves
yy
Utility gloves
yy
Basins
yy
Basins
yy
Detergents
yy
Detergents
yy
Chlorine solution 0.5%
yy
Chlorine solution 0.5%
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Female Sterilization Operation Theatre
yy
Operating table capable of Trendelenburg’s position
yy
Step up stool
yy
Spotlight in OT
yy
Instrument trolley
yy
Mini Laparotomy Kit
yy
Laparoscopy Kit
yy
Blood Pressure Instrument
yy
Stethoscope
yy
Syringe with needles
yy
Emergency equipment & Drugs
yy
Room heater
yy
IV stand
yy
Waste basket, storage cabinet,buckets, yy basins for decontamination yy Box for used linen yy Puncture –proof box for needles
Box for used linen
yy
Patient’s cot with mattress, sheet, pillow, pillow cover and blankets
yy
Patient’s cot with mattress, sheet, pillow, pillow cover and blankets
yy
BP Instrument
yy
Thermometers
yy
Stethoscope
yy
Stethoscope
yy
Thermometers
yy
Blood pressure instrument
yy
IV stand
yy
IV stand
yy
Emergency equipment and drugs as per list
yy
Emergency equipment and drugs as per list
yy yy
Recovery room
Male Sterilization
174
yy
Operating table
yy
Step up stool
yy
Spotlight in OT
yy
Instrument trolley
yy
Conventional Vasectomy Kit
yy
No- Scalpel Vasectomy Kit
yy
Emergency equipment &Drugs
yy
Room heater
yy
Blood Pressure Instrument
yy
Stethoscope
yy
Syringe with needles
yy
Waste basket, storage cabinet,buckets, basins for decontamination
Puncture –proof box for needles IV stand
Reference Manual for Doctors on Family Planning and Reproductive Health
Female Sterilization Emergency equipment & supplies
Male Sterilization
yy
Stethoscope
yy
Stethoscope
yy
BP instruments
yy
BP instruments
yy
Oral Airways guedel size 3,4,5
yy
Oral Airways guedel size 3,4,5
yy
Nasopharyngeal airways size 6,6.5,7.0
yy
Nasopharyngeal airways size 6,6.5,7.0
yy
Suction machine with tubing & two straps
yy
Suction machine with tubing & two straps
yy
Ambu bag with mass size 3,4,5
yy
Ambu bag with mass size 3,4,5
yy
tubing and oxygen nipple
yy
tubing and oxygen nipple
yy
Oxygen cylinder with reducing valve and flow meter
yy
Oxygen cylinder with reducing valve and flow meter
yy
Blanket
yy
Blanket
yy
Gauge pieces
yy
Gauge pieces
yy
Kidney tray
yy
Kidney tray
yy
Torch
yy
Torch
yy
Syringes and needles, including butterfly sets, IV Cannula
yy
Syringes and needles, including butterfly sets, IV Cannula
yy
Intravenous infusion sets and fluids
yy
Intravenous infusion sets and fluids
yy
Sterile laparotomy instruments
yy
Sterile laparotomy instruments
yy
Endotrachael tube size 6, 6.5, 7, 7.5, 8.0
yy
Endotrachael tube size 6, 6.5, 7, 7.5, 8.0
yy
Laryngeal mask airway size 3,4,5
yy
Combitube
yy
Cricothyroidectomy set
yy
Laryngeal mask airways
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Female Sterilization Emergency drugs
Male Sterilization
yy
Injection Adrenaline
yy
Injection Adrenaline
yy
Injection Atropine
yy
Injection Atropine
yy
Injection Hydrocortisone (Dexamethasone)
yy
yy
Injection Physostigmine
Injection Hydrocortisone (Dexamethasone)
yy
Injection Aminophylline
yy
Injection Physostigmine
yy
Injection Diazepam
yy
Injection Diazepam
yy
Injection Deriphyline
yy
Injection Deriphyline
yy
Injection Pheniramine Maleate
yy
Injection Pheniramine Maleate
yy
Injection Promethazine
yy
Injection Promethazine
yy
Injection Ranitidine
yy
Injection Ranitidine
yy
Injection Metoclopramide
yy
Injection Metoclopramide
yy
Injection Xylocard
yy
Injection Xylocard
yy
Injection Pentazocine
yy
Injection Pentazocine
yy
Injection Sodium Bicarbonate
yy
yy
Injection Calcium Gluconate/ Calcium Chloride
Injection Sodium Bicarbonate (7.5 %)
yy
Injection Frusemide
yy
yy
Injection Methergine
Injection Calcium Gluconate/ Calcium Chloride
yy
Injection Dopamine
yy
Injection Frusemide
yy
Injection Mephentermine
yy
Injection Dopamine
yy
Injection Oxytocin
yy
Injection Mephentermine
yy
Electorde jelly
yy
Electorde jelly
yy
Water –soluble jelly IV fluids
yy
Water –soluble jelly.
yy
Dextrose 5%
IV fluids
yy
Glucose 25%
yy
Dextrose 5%
yy
Ringer Lactate solution.
yy
Glucose 25%
yy
0.9% sodium chloride (normal saline)
yy
Ringer Lactate solution.
yy
Heta Starch (HES 6 %) (7.5 %)
yy
yy
Injection Calcium Gluconate/ Calcium Chloride
0.9% sodium chloride (normal saline)
yy
Injection Frusemide
yy
Heta Starch (HES 6 %)
yy
Injection Methergine
yy
Injection Dopamine
yy
Injection Mephentermine
yy
Injection Oxytocin
IV fluids yy
Dextrose 5%
yy
Glucose 25%
yy
Ringer Lactate solution.
yy
0.9% sodium chloride (normal saline)
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Annexure 11 Commonly available brands of contraceptives Product
Manufacturer
1. Male Condoms yy Ahsaas
-
yy Bliss
-
yy Deluxe Nirodh
PSI
yy Masti
-
yy Mauj
-
yy Milan
-
yy Mithun
-
yy New Lubricated Nirodh
-
yy Pick Me
-
yy Sangam
-
yy Sawan
-
yy Super Deluxe Nirodh
-
yy Ustad
-
yy Zaroor
-
yy Sathi
-
yy Sparsh
-
yy Thrill 2. Female Condoms yy FC 2R Also known as Femidon, Protective Care yy VA w.o.w
Female Health Company Medtech Products Ltd Cupid
yy CupidTM 3. Common IUD brands in India
Organon
yy ParaGard Interuterine Device (Cu T380a/ Multiload) yy Freedom 5 177
Drug Formulation
Annexures
Product
Manufacturer
4. Common LNG IUD brands in India
Zydus
yy Mirena
5. Vaginal Ring
Drug Formulation Levonorgestrel USP, 13-Ethyl17-hydroxy-18,19-dinor-17 alpha-pregn-4-en-20-yn-3one
Organon
yy Nuva ring Organon
6. Ultra Low dose COCâ&#x20AC;&#x2122;s yy Femilon
Wyeth Ltd
yy Loette 7. Minipills yy Norethindrone(Micronan)
Genetic Pharma/ Symbiosis/ Novartis VHB (Gen Biotech)
yy Livonorgestel (Neogest)
Ethinyl Estradiol 0.02mg/0.15mg Levonorgestrel 0.10mg ethinylestradiol 0.02mg 0.75 mg Levongestrel 19-nor-17aethnyltestosterone 30ug levonorgestrel)
yy Norgestrel (microval) 8. Injectables yy Depo Provera
Pfizer
(1ml in prefilled syringe)
yy Depo Provera (1ml vial)
Pfizer (Wyeth) / DKT
yy Depo Progestin (1ml vial)
Harshen Lab / DKT
yy Paree
Famy care, SDRL / Janani
yy Petogen (1ml vial)
HLL
yy Procosteron 150 (1ml vial)
Star Drugs and Research Labs / PSI
yy Myone Depot
Sun Pharmaceuticals Ind. L td.
yy Khushi (1ml vial with Disposable Star Drugs & Research Labs syringe & needle) (SDRL) / PHSI 9. SDM cycle Beads
HLL
yy Mala chakra
HLL
yy Ritumala
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Depot medroxyprogesterone acetate
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