October 2010, Vol 2, No 5 by Novellus Healthcare Communications, LLC

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OCTOBER 2010

WWW.OBGYN-INFERTILITY-NURSE.COM

VOL 2, NO 5

e Nursing and Women’s Health

CLINIC PROFILE

Genetics & IVF Institute

Let’s Take the Lead in 2011

Donor Egg and Egg Vitrification Interview with Jennifer Machovina, RN, BSN Coordinator, Donor Egg Program, Genetics & IVF Institute, Fairfax, VA

Debra Moynihan, WHNP-BC, MSN Clinical Director, Carolina OB/GYN, Murrells Inlet, SC

s we look back on the first decade of the new millennium, we can appreciate many of the advances in the field of women’s health that have changed so many lives. We have made contraceptive choices more diverse with the introduction of Ortho Evra patches, NuvaRing, and 3-month oral contraceptives, such as Seasonale and Seasonique. Tremendous progress has been realized with the addition of digital mammography to aid in earlier diagnosis and treatment of breast cancer. Also, the development of new med-

ications that can be given once a year intravenously for the treatment of osteoporosis makes adherence to weekly or monthly medication a nonissue for patients. These measures have made positive changes in the way we manage our patients and their outcomes of care. Healthy People 2010 Goals Despite the Department of Health and Human Services’ Healthy People 2000 goals, women—who comprise 50.7% of the US population—are still struggling to attain the goals set 10 Continued on page 4

Donor Egg team, left to right: Kristy Bahr, Aisha Shahid, Stephanie Trimmer, Jennifer Machovina, and Liz Andrade.

SPOTLIGHT

Amniotic Fluid Banking in Prenatal Amniocentesis

What makes your clinic different from other infertility practices? We are truly a full-service infertility practice: we offer the entire spectrum of female and male infertility treatment, plus genetic services, diagnostic testing, laboratory services, and patient support services. We have our own cryobank for patients needing anonymous donor sperm, and we recently started our own Continued on page 6

AWHONN HIGHLIGHTS

“Glimmers of Hope” for Improving the Health of Women, Newborns By Caroline Helwick

mproving the health of women and newborns around the world is a goal that is within our reach,” said Leslie Mancuso, PhD, RN, FAAN, President and Chief Executive Officer of Jhpiego, an international nonprofit organization focused on women’s health and is affiliated with Johns Hopkins University. Dr Mancuso, who has led Jhpiego from an annual budget of $5 million to $85 million, delivered the keynote

address at the 2010 meeting of the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN). Her inspiring remarks centered on Mahatma Gandhi’s challenge, “Be the change that you want to see in the world.” She called on the thousands of nurses who attended the meeting to identify, commit to, and believe in making their own change, and asked them to join nurses around the world who are Continued on page 9

The Official Publication of

Michael Jingco, RN, NP OB/GYN Clinical Educator, Biocell Center, Medford, MA

ver the past few years, a type of cell that floats freely in the amniotic fluid of pregnant women has been found to have traits similar to embryonic stem cells, including the ability to grow into different tissues that can ultimately be used to treat a variety of diseases. These pluripotent, mesenchymal stem cells can be easily obtained during prenatal genetic amniocentesis and cryopreserved for later use. More important, the collection and use of stem cells from amniotic fluid side-steps the ethical hurdles facing embryonic stem-cell applications, because amniotic fluid stem cells are harvested with no harm to the embryo.

Photo courtesy of Biocell Center.

he Genetics & IVF Institute was one of the first infertility practices established in the United States more than 26 years ago. Jennifer Machovina is a reproductive endocrinology and infertility nurse, with a concentration in donor egg in vitro fertilization (IVF), gestational surrogacy, and donor embryo. She described the institute and her work there.

A microscopic view of stem cells.

Why Preserve Amniotic Fluid? Amniotic fluid is one of the richest sources of mesenchymal stem cells. These cells are very young in their development, are genetically stable, and Continued on page 22

Inside AWHONN Highlights New Guidelines for Staffing Perinatal Units, Page 9 Nurses’ Novel Checklist for Oxytocin, Page 10 Women’s Health Desvenlafaxine Effective in Perimenopause/Menopause, Page 12

Pharmacy Corner Treating Nausea & Vomiting in Pregnancy Page 15 Complimentary CE Management of Ectopic Pregnancy, Page 16 Infertility Updates Vitrification of Human Blastocysts, Page 18 Steroid Abuse and Male Infertility, Page 24

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CONTENTS

october 2010 • Vol 2 • No 5

PUBLISHING STAFF

Managing Director Jack Iannaccone jack@infertilitynurse.org 732-992-1537 Editorial Director Dalia Buffery dalia@novellushc.com 732-992-1889 Associate Editor Lara J. Reiman lara@novellushc.com 732-992-1892 Editorial Assistant Jessica A. Smith Director, Client Services Russell Hennessy russell@novellushc.com 732-992-1888 Director, Client Services Mark Timko mark@novellushc.com 732-992-1897 Senior Production Manager Lynn Hamilton Business Manager Blanche Marchitto Editorial Contact: Telephone: 732-992-1892 Fax: 732-656-7938

CLINICAL NEWS

5 Puberty Onset in American Girls Now as Early as Age 7 Testosterone Therapy in Elderly Men Increases CV Events New Prescription-Only Emergency Contraceptive First Combination OC with Folate

Obesity in Pregnancy a Long-Term Risk for Offspring

23 Bariatric Surgery Alleviates Gestational Diabetes, Cesarean Risk Nonbreastfeeding Increases Risk for Diabetes Pelvic Radiation before Puberty a Risk for Stillbirth, Neonatal Death Low-Dose Estrogen Patch Avoids Stroke Risk from HRT

THE OB/GYN NURSE

9 New AWHONN Guidelines for Staffing Perinatal Units Focus on

Nurses’ Achievements AWHONN Highlights

10 Nurses Introduce Oxytocin Checklist to Push “the Pit” Safely and Effectively AWHONN Highlights

11 Preeclampsia Can Be Predicted by 2 Variables AWHONN Highlights 12 Psychological Violence by Partner during Pregnancy a Risk for Postpartum Depression

MISSION STATEMENT The OB/GYN Nurse-NP/PA is the official publication of the American Academy of OB/GYN Nurses. The OB/GYN Nurse-NP/PA provides practical, authoritative, cutting-edge information on the physiologic, medical, and psychological aspects of women’s health, focusing on the role of the OB/GYN practitioner, including nurses, NPs, and PAs, in patient care. Our journal offers a forum for nurses, nurse practitioners, physician assistants, administrators, researchers, and all others involved in OB/GYN and women’s health to discuss the entire scope of current and emerging diagnostic and therapeutic options, as well as counseling and patient follow-up for women throughout their reproductive years and beyond. Written by nurses for nurses, The OB/GYN NurseNP/PA promotes peer-to-peer collaboration among all nursing professionals toward the advancement of integrated services for optimal delivery of patient care and offers continuing education for all nurses, NPs, and PAs involved in these interrelated fields of women’s health. The OB/GYN Nurse, ISSN 2153-6562 (print); ISSN 2153-6546 (online), is published 6 times a year by Novellus Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831. Copyright ©2010 by Novellus Healthcare Communications, LLC. All rights reserved. The OB/GYN Nurse is a trademark of Novellus Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. The ideas and opinions expressed in The OB/GYN Nurse do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher. Publication of an advertisement or other product mentioned in The OB/GYN Nurse should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issue, $17.00. Orders will be billed at individual rates unless proof of status is confirmed. SUBSCRIPTIONS/CHANGE OF ADDRESS should be directed to CIRCULATION DIRECTOR, The OB/GYN Nurse, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831; Fax: 732-656-7938.

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Desvenlafaxine Safe, Effective for Major Depression during Perimenopause and Menopause

14 Bariatric Surgery Lowers Risk for Hypertension in Subsequent

Pregnancies

PHARMACY CORNER

15 Treatment Options for Nausea and Vomiting during Pregnancy CONTINUING EDUCATION

16 Recognition and Management of Ectopic Pregnancy 17 Commentary: Advances in the Management of Ectopic Pregnancy THE INFERTILITY NURSE

18 Vitrification of Human Blastocysts: The Way to Go 22 IVF Pioneer Winner of Nobel Prize in 2010 Amniotic Fluid Banking

THE UROLOGY NURSE

24 Androgenic-Anabolic Steroid Abuse and Male Infertility Active Surveillance Recommended for Small, Incidental Testicular Masses

NUTRITION

26 Eating Healthy Food Does Not Have to Cost More Mediterranean Diet Confers Protective Effects Against Obesity

27 Moderate Caffeine in Pregnancy Not Linked to Miscarriage, Preterm Birth

Coming in December BER DECEM

Highlights from the 2010 annual meetings of ASRM, NAMS, and SUNA

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From the Editors

Nursing and Women’s Health... years ago. One of the most important goals was to increase the proportion of all pregnant women who receive prenatal care in the first trimester to 90%, but the current national average stands at 78%. As of 2003, only 4 states had met the 90% goal. According to the National Report Card on Women’s Health (2004-2005), between 9.1% and 28.1% of American women in various states still did not receive prenatal care in the first trimester. Therefore, a decade later, the goal of Healthy People 2010 remains the same as in 2000, to increase the numbers to 90% over the next decade. Barriers to Care The difficulty in achieving this goal is partly beyond our control, but several barriers to care exist throughout the country. A lack of insurance has been one of the biggest obstacles. One of the Healthy People 2010 goals is for 100% of the population to have health insurance, but approximately 16.7% of the population is without insurance. Even with all the changes to our healthcare policy, there will still be persons who are either not insured or are underinsured. Other barriers include transporta-

Continued from page 1

Never be afraid to step up to the plate. Nurses in women’s health are vital. We are caring for a little more than 50% of the population. tion to office visits, child care, and differences in language and culture. Services such as transportation and child care may not be things we can individually provide, but as nurses we can assist the patient in securing these so that they could attend their prenatal visits. Sometimes we need to reach out to the community to see what is available and network with other agencies to provide better patient care. As the US population grows more diverse, nurses may need to seek out educational opportunities to learn more about cultural diversity and better understand patient backgrounds to customize their treatment accordingly. The Vital Role of Nurses An important thing to remember is that most healthy women do not seek

care by a medical provider until they become pregnant. This may be their introduction to the medical community. First impressions are usually lasting. This is an important concept for many hospitals, because women are usually the caretakers of the family. If a woman’s first contact with a hospital is to deliver a baby, and she has a good experience, she will bring the rest of her family to that facility. We are not only treating women; we are treating families. Wives and mothers need to be healthy to take care of their families. Their health can have an impact on their families and society. Some of the national Key Health Issues for 2010 are access to quality care, breast and cervical cancer, domestic violence, high teen pregnancy rates, high infant mortality, mental health

and substance abuse, chronic diseases (eg, heart disease, stroke, and diabetes), and the rise in HIV/AIDS. Those of us involved in women’s health have a professional responsibility to be familiar with these issues and to be involved in making a positive influence on healthcare policy. These are all issues related to women’s health, and we obviously have a long road ahead of us. I do believe, however, that we can make a difference. Over the years I have met so many dedicated nurses who have expressed much enthusiasm about wanting to initiate change. Never be afraid to step up to the plate. I invite every nurse in women’s healthcare to seriously consider a women’s health issue that really concerns you, whether on a personal or professional level, and research an avenue that will enable you to contribute to the cause and initiate a change. Let’s move into 2011 with a refreshed enthusiasm, and take the lead over the next decade. Nurses in women’s health are vital. We are caring for a little more than 50% of the population. Through passion and dedication as nurses, progress in women’s health should always continue to be a lifetime goal. ■

Editorial Board

Co-Editor-in-Chief Sue Jasulaitis, RN, MS Clinical Research Manager Fertility Centers of Illinois, Chicago

Donielle Farrington, RNC Clinical Nursing Manager Brunswick Hills OB/GYN, NJ

Norah S. Nutter, MSN, WHNP-BC, IBCLC Women’s Health Nurse Practitioner Magnolia OB/GYN Myrtle Beach, SC

Co-Editor-in-Chief Debra Moynihan, WHNP-BC, MSN Women’s Health Nurse Practitioner Carolina OB/GYN, SC

Sandra Fernandez, RPh, PharmD Pharmacist Mandell’s Clinical Pharmacy, NJ

Kutluk Oktay, MD, FACOG Director, Division of Reproductive Medicine & Infertility, Department of Obstetrics & Gynecology; Director, Institute for Fertility Preservation, NY

Barbara Alice, RN, APN-C, MSN Nursing Manager, IVF Coordinator South Jersey Fertility Center

Jennifer Iannaccone, RNC

Monica R. Benson, BSN, RNC Nurse Manager Third Party Reproduction, RMA New Jersey

Juergen Liebermann, PhD, HCLD IVF Laboratory Director River North Fertility Centers of Illinois Chicago

Melissa B. Brisman, Esq Owner Reproductive Possibilities, LLC Surrogate Fund Management, LLC

Donna Makris, RN, BSN, IBCLC Parent Education Coordinator OB/GYN, St. Peter’s Medical Center, NJ

Kit Devine, MSN, ARNP Advanced Nurse Practitioner Fertility & Endocrine Associates, Kentucky

Mary M. Macgregor, RNC IVF Nurse Coordinator Fertility Institute of New Orleans, LA

Gina Paoletti-Falcone, RN, BSN Clinical Services Manager Freedom Fertility Pharmacy Byfield, MA

Jill Marchetti, RN Director, Egg Donor Program IVF New Jersey

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Nursing Manager, IVF Coordinator IVF New Jersey

Cyndi Gale Roller, PhD, RN, CNP, CNM Program Director, Women’s Health College of Nursing Kent State University, OH Christopher S. Sipe, MD OB/GYN & Reproductive Endocrinology Fertility Centers of Illinois, Chicago Kriston Ward, RN, MS, NP-C Strong Fertility Center University of Rochester Medical Center, Rochester, NY Patricia Rucinsky, RN, BSN Clinical Nurse Manager IRMS, St. Barnabas, NJ Joan Zaccardi, MS, DrNP Administrative Practice Manager Urogynecology Arts of New Jersey

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Clinical News Puberty Onset in American Girls Now as Early as Age 7

First Combination OC with Folate

The results of a recent study give new meaning to parentsâ&#x20AC;&#x2122; laments that their children are growing up too quickly, showing that more girls today than a decade ago are reaching puberty by age 7 or 8 years (Biro FM, et al. Pediatrics. 2010;126:e583-e590. Epub 2010 Aug 9). A total of 1239 girls aged 6 to 8 years were included in the study. Puberty onset was defined as reaching breast stage 2, which varied by ethnicity/race, body mass index, and geographical site. By age 7, as many as 10.4% of the white girls, 23.4% of the non-Hispanic black girls, and 14.9% of the Hispanic girls had met the definition of puberty. By age 8, 18.3% of the white girls, 42.9% of the non-Hispanic black girls, and 30.9% of the Hispanic girls had reached puberty. The researchers noted that the increase in young girls developing breasts at ages 7 and 8 years was particularly significant among white girls.

Beyaz tablets are the newest addition to the contraceptive armamentarium, after gaining FDA approval in September. A combined estrogen/progestin oral contraceptive (OC), Beyaz is the first OC that also contains folate (levomefolate calcium 0.451 mg), to reduce the risk for neural tube defects in fetuses conceived during use of, or shortly after

discontinuing, an OC product. Clinical trials showed that Beyaz increases folate levels in women. The new OC is based on YAZ, the combination OC with the same estrogen and progestin doses.

Obesity in Pregnancy a Long-Term Risk for Offspring Excess pounds added during pregnancy are associated not only with increased birth weight but also with an

increased risk for obesity in the offspring later in life, new data from 513,501 women and their 1,164,750 offspring show (Ludwig DS, et al. Lancet. 2010;376: 984-990). Women who gained >24 kg (52.9 lb) during pregnancy delivered infants 148.9 g (0.32 lb) heavier than the newborn infants of women who gained between 8 kg and 10 kg (17.6 lb22.0 lb) during pregnancy; women with Continued on page 23

Testosterone Therapy in Elderly Men Increases CV Events For older men with limited mobility, testosterone therapy is associated with increased risk for cardiovascular (CV) events, as well as other adverse events (AEs), according to a new study (Basaria S, et al. N Engl J Med. 2010; 363:109-122). A total of 209 men (mean age, 74 years) with limited mobility, low testosterone levels, and chronic disease were randomized to testosterone gel or to a placebo gel for 6 months. Despite improved physical strength in the testosterone group compared with the placebo group, the study was discontinued early because of the significant increase in AE rate in the men receiving testosterone. The CV events posed the greatest cause for concern. In the testosterone group, 23 men had a CV event compared with 5 men in the placebo group.

New Prescription-Only Emergency Contraceptive In August, the FDA approved ella (ulipristal acetate), a progesterone agonist/antagonist that inhibits follicular rupture when taken just before ovulation, as a prescription-only tablet for emergency contraception to be used within 5 days after unprotected intercourse or contraceptive failure, as opposed to the 3-day use with levonorgestrel-based emergency contraceptives. The Family Research Council (FRC) has claimed that ella is chemically similar to RU-486 (mifepristone) and can therefore cause abortion. The FRC is urging their supporters to present an anti-ella flyer to pharmacists to discourage the dispensing of this new contraceptive.

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Clinic Profile

Genetics & IVF Institute... program for frozen donor eggs, the Fairfax Egg Bank. Our main location is in Fairfax, VA, and we have recently opened a satellite office in North Bethesda, MD. We are large enough to provide our patients with all the resources they need to succeed, but small enough to give them personalized care and individualized attention. Patients are not “just a number” when they come to our practice; they are individuals and families whom we get to know and care about. Our team is comprised of 5 physicians, 7 nurses, and 4 egg donor coordinators; we are all committed to “being there” for patients on a professional and a personal level. Our clinic is well known for our donor egg IVF program, which focuses on 3 key areas—delivering expert clinical care, offering a diverse range of quality donors, and outstanding success rates. Our large, well-screened egg donor pool gives patients a wide selection of donors. We are committed to giving patients maximum control over their treatment, including donor selection, pace of treatment, and financial options. Empowering patients through knowledge and understanding of their reproductive options is as important to us as helping them realize their dream of having a baby.

How does the field of “genetics” fit into your practice? Genetic services comprise another unique aspect of our practice. A boardcertified clinical geneticist and 4 genetic counselors are involved in the egg donor screening process and are available to patients for counseling and screening before conception and during infertility treatments. The genetics team works closely with our reproductive endocrinologists and infertility nursing team, which is a benefit of having all our services in-house. Genetic services are also available to help patients during first- and secondtrimester screening, amniocentesis, and chorionic villus sampling. They can also

Continued from page 1

As infertility nurses, we have all had a patient who has been unsuccessful with IVF but cannot afford donor eggs. —Jennifer Machovina, RN, BSN

help patients to understand pregnancy losses or recurrent miscarriages, as well as counsel patients who have a family history of genetic disease and/or agerelated risk factors.

What is your specific role in the donor egg IVF program? As the Donor Egg IVF Program Coordinator, I lead the team of donor egg coordinators, all of whom have previous healthcare experience and a diverse education. Each patient using donor eggs is assigned a physician, a donor egg coordinator, and a financial counselor. Our coordinators are the backbone of the program, because they provide patient support, assistance in selecting a donor, and cycle coordination. They work closely with the physicians and nurses to coordinate the cycles of donor egg recipients and egg donors, and guide the donor and the recipient through the process. With help from our team of coordinators, I have focused on enhancing the donor egg recipient experience. Choosing third-party reproduction is frequently a huge step for infertility patients, many of whom have been unsuccessful with IVF and their only

viable option to get pregnant is to use donor eggs. We help patients to navigate all the reproductive choices so that they can make an informed decision. Reproductive decisions are intensely personal, and we strive to foster a safe and trusting environment in which our patients’ individual choices are respected. This includes offering patient support groups and counseling opportunities not only for patients undergoing donor egg IVF but also for those who are considering it.

Who are your donor egg IVF patients? Our donor egg IVF patients are typically women in their 30s and 40s whose eggs are no longer viable as a result of age-related diminished ovarian reserve, premature ovarian failure, surgical menopause, or unexplained infertility. We treat an average of 135 donor egg IVF patients annually, not including patients who choose other familybuilding options. We have a very diverse patient population, as well as many out-of-town and international patients. Our team is as comfortable coordinating care for patients who live locally as they are for those who live 1000 miles away. We incorporate Skype sessions and even have a concierge service to assist patients with their travel plans. We see many European patients, particularly those from countries with egg donor shortages.

How do patients find your center? Some patients are referred to us by their OB/GYNs or primary care physicians, others find us after conducting their own research, and many come to us as a result of word of mouth. The latter is very powerful, because former patients are usually happy to tell others of their positive experiences with us. In general, we find that our patients decide to come to our practice because of our excellent success rates and personalized attention.

Who are your egg donors?

Egg vitrification at Genetics & IVF Institute.

october 2010 I Vol 2, No 5

Our egg donors are healthy women between the ages of 19 and 33 years. We do all screening in-house, which involves a very rigorous process of health, psychological, and other screening and testing. We offer more than 150 egg donors—one of the largest egg donor pools in the country. Only a small percentage of applicants are accepted as donors, because few meet our program’s selective standards. The donor screening coordinator spends much time with each donor to get to know her and to make sure she fully understands the risks of egg donation and the time it requires.

See also article on vitrification of blastocysts on page 18. Donor recipients can select their egg donor based on criteria such as ethnicity, physical characteristics, educational history, or other characteristics. We provide a lot of information and are one of the few practices to offer childhood and current photos of each donor.

Can you discuss egg vitrification? Egg vitrification is the cryopreservation of eggs using a special type of freezing method. Vitrifying eggs is still relatively new but is used by clinics around the world and has led to approximately 1000 births worldwide. Although scientists have been able to freeze and thaw sperm and embryos for many years, cryopreserving eggs is a more delicate process. The use of vitrification has led to a dramatic improvement in oocyte survival, fertilization rates, and pregnancy rates when done correctly. We are vitrifying eggs for elective oocyte cryopreservation and for our frozen donor egg bank. Elective oocyte cryopreservation is a new service available to women aged <40 years who plan to delay childbearing and wish to bank their eggs for their own future use. Our Fairfax Egg Bank is a cryobank for donor eggs, not donor sperm. We are excited to be able to offer frozen donor eggs as another option for our patients.

How are frozen eggs different from fresh eggs in donor egg IVF? Frozen eggs offer patients many advantages. Using frozen donor eggs is more flexible than the traditional donor egg IVF; it gives patients the ability to schedule their treatment at their convenience. The immediate availability of frozen eggs allows patients to begin treatment as quickly as they wish. It is also more affordable, which expands access to patients who may not be able to afford traditional donor egg IVF. Frozen-egg technology is relatively new; therefore, data reflecting the long-term success of frozen donor eggs as opposed to fresh donor eggs are limited. However, our program has seen live births from frozen eggs, and in the laboratory we have seen progression with frozen eggs similar to that seen with fresh eggs. The best part about frozen donor eggs is being able to offer patients another option. As infertility nurses, we have all had a patient who has been unsuccessful with IVF but cannot afford donor eggs. The option of using frozen donor eggs gives such patients hope and a chance to fulfill their dreams. Being able to deliver the good news to them is the best part of my day and the best part of helping patients start families. ■

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One and done. Teach only 1 lesson from OI to IVF with BRAVELLE® and hMG.

BRAVELLE® administered SC or IM in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression. BRAVELLE® administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. Important Safety Information BRAVELLE® is contraindicated in women who have: a high FSH level indicating primary ovarian failure, uncontrolled thyroid and adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, abnormal uterine bleeding of undetermined origin, or ovarian cysts or enlargement not due to polycystic ovary syndrome. BRAVELLE® is contraindicated in women who have the presence of any cause of infertility other than anovulation. BRAVELLE® is contraindicated in women with a prior hypersensitivity to urofollitropins, puriﬁed. BRAVELLE® is not indicated in women who are pregnant. BRAVELLE® may cause fetal harm when administered to a pregnant woman. BRAVELLE® should only be used by physicians who are thoroughly familiar with infertility problems. BRAVELLE® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) (overall IVF incidence of 6.0%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Serious pulmonary conditions and thromboembolic events have been reported with BRAVELLE®. Multiple pregnancies have occurred following treatment with BRAVELLE®. The most common adverse reactions (≥10%) reported in an IVF clinical trial and donor IVF study (N=150) of BRAVELLE® SC were abdominal cramps and headache. Please see Brief Summary of Prescribing Information on the adjacent page.

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FOR SUBCUTANEOUS AND INTRAMUSCULAR INJECTION For full prescribing information, see package insert. A brief summary follows. INDICATIONS AND USAGE: Ovulation Induction: Bravelle®, administered SC or IM in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression. Multifollicular Development During ART: Bravelle®, administered SC in conjunction with hCG, is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. Selection of Patients: 1) Before treatment with Bravelle® is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. Except for those patients enrolled in an in vitro fertilization program, this should include a hysterosalpingography (to rule out uterine and tubal pathology) and documentation of anovulation by means of basal body temperature, serial vaginal smears, examination of cervical mucus, determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy. Patients with tubal pathology should receive Bravelle® only if enrolled in an in vitro fertilization program. 2) Primary ovarian failure should be excluded by the determination of gonadotropin levels. 3) Careful examination should be made to rule out the presence of an early pregnancy. 4) Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for diagnosis before starting Bravelle® therapy in such patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities. 5) Evaluation of the husband’s fertility potential should be included in the workup. CONTRAINDICATIONS: Bravelle® is contraindicated in women who have: 1) A high FSH level indicating primary ovarian failure. 2) Uncontrolled thyroid and adrenal dysfunction. 3) An organic intracranial lesion such as pituitary tumor. 4) The presence of any cause of infertility other than anovulation. 5) Abnormal bleeding of undetermined origin. 6) Ovarian cysts or enlargement not due to polycystic ovary syndrome. 7) Prior hypersensitivity to urofollitropins, purified. 8) Bravelle® is contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. There are limited human data on the effects of Bravelle® when administered during pregnancy. WARNINGS: Bravelle® is a drug that should only be used by physicians who are thoroughly familiar with infertility problems. It is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications in women. Bravelle® therapy requires a certain time commitment by physicians and supportive health professionals, and its use requires the availability of appropriate monitoring facilities (see PRECAUTIONS–Laboratory Tests section). Bravelle® should be used with a great deal of care. Overstimulation of the Ovary During Bravelle® Therapy: Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distension and/or abdominal pain occurs in approximately 20% of those treated with follitropin and hCG, and generally regresses without treatment within two or three weeks. In order to minimize the hazard associated with the occasional abnormal ovarian enlargement, which may occur with FSH-hCG therapy, the lowest dose consistent with expectation of good results should be used. Careful monitoring of ovarian response can further minimize the risk of overstimulation. If the ovaries are abnormally enlarged on the last day of Bravelle® therapy, hCG should not be administered in the course of therapy; this will reduce the chances of development of the Ovarian Hyperstimulation Syndrome. OHSS: OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS may progress rapidly to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. The following symptomatology has been seen with cases of OHSS: abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events (see Pulmonary and Vascular Complications below). Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with the Ovarian Hyperstimulation Syndrome (OHSS). In a clinical study of ovulation induction, 6 of 72 (8.33%) Bravelle®-treated women developed OHSS and two were classified as severe. In a clinical study for multiple follicular development during IVF, 3 of 60 Bravelle®-treated women developed OHSS and 1 was classified as severe. Cases of OHSS are more common, more severe and more protracted if pregnancy occurs. OHSS develops rapidly; therefore patients should be followed for at least two weeks after hCG administration. Most often, OHSS occurs after treatment has been discontinued and reaches its maximum at about 7 to 10 days after treatment. Usually, in cases where OHSS may be developing prior to hCG administration (see PRECAUTIONS-Laboratory Tests), the hCG should be withheld. If severe OHSS occurs, treatment must be stopped and the patient should be hospitalized. A physician experienced in the management of the syndrome, or who is experienced in the management of fluid and electrolyte imbalances, should be consulted. Pulmonary and Vascular Complications: Serious pulmonary conditions (e.g. atelectasis, acute respiratory distress syndrome) have been reported. In addition, thromboembolic events both in association with, and separate from, the Ovarian Hyperstimulation Syndrome have been reported following FSH therapy. Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or the extremities. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, pulmonary complications and/or thromboembolic events have resulted in death. Multiple Pregnancies: Multiple pregnancies have occurred following treatment with Bravelle® SC and IM. Pregnancy outcomes in a controlled study of 72 patients undergoing ovulation induction with Bravelle® were as follows: Total continuing pregnancies in patients in the 2 study groups—Bravelle® SC (N=9) and Bravelle® IM (N=7), respectively—were as follows (patients, or patients/percent, where applicable): Singlets: 3/33.3; 5/71.4; Total number with multiple pregnancies: 6/66.7; 2/28.6; Twins: 4; 0; Triplets: 2; 0; Quadruplets: 0; 1; Quintuplets: 0; 0; Sextuplets: 0; 1. Pregnancy outcomes in a controlled study of 60 patients undergoing treatment with Bravelle® SC in IVF were as follows: Total number of continuing pregnancies (N=23) were as follows (patients, or patients/percent, where applicable): Singlets: 15/65.2; Total number of multiple pregnancies: 8/34.8; Twins: 5; Triplets: 3. The patient and her partner should be advised of the potential risk of multiple births before starting treatment.

Hypersensitivity/Anaphylactic Reactions: Hypersensitivity/anaphylactic reactions associated with follitropins for injection, purified administration have been reported in some patients. These reactions presented as generalized urticaria, facial edema, angioneurotic edema, and/or dyspnea suggestive of laryngeal edema. The relationship of these symptoms to uncharacterized urinary proteins is uncertain. PRECAUTIONS: General: Careful attention should be given to the diagnosis of infertility in the selection of candidates for Bravelle® therapy (see INDICATIONS AND USAGE– Selection of Patients section). Information for Patients: Prior to therapy with Bravelle®, patients should be informed of the duration of treatment and the monitoring of their condition that will be required. Possible adverse reactions (see ADVERSE REACTIONS section) and the risk of multiple births should also be discussed. Laboratory Tests: The combination of both estradiol levels and ultrasonography are useful for monitoring the growth and development of follicles, timing hCG administration, as well as minimizing the risk of the Ovarian Hyperstimulation Syndrome and multiple gestations. The clinical confirmation of ovulation is determined by: a) A rise in basal body temperature; b) Increase in serum progesterone; and c) Menstruation following the shift in basal body temperature. When used in conjunction with indices of progesterone production, sonographic visualization of the ovaries will assist in determining if ovulation has occurred. Sonographic evidence of ovulation may include the following: a) Fluid in the cul-de-sac; b) Ovarian stigmata; and c) Collapsed follicle. Because of the subjectivity of the various tests for the determination of follicular maturation and ovulation, it cannot be overemphasized that the physician should choose tests with which he/she is thoroughly familiar. Carcinogenesis and Mutagenesis: Long-term toxicity studies in animals and in vitro mutagenicity tests have not been performed to evaluate the carcinogenic potential of urofollitropin for injection, purified. Pregnancy: Pregnancy Category X: See CONTRAINDICATIONS section. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Bravelle®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Patients: Safety and effectiveness in pediatric patients have not been established. Geriatric Patients: Safety and effectiveness in geriatric patients have not been established. ADVERSE REACTIONS: The safety of Bravelle® was examined in four clinical studies that enrolled a total of 222 patients receiving Bravelle®, including 72 for ovulation induction and 150 for IVF. All adverse events (without regard to causality assessment) occurring ≥2% incidence in the clinical study patients receiving Bravelle® are listed as follows: FPI FSH 99-03 Study for Ovulation Induction: All patients with adverse events ≥2% for Bravelle® SC (N=35) and Bravelle® IM (N=37), respectively, were as follows (patients/percent): Genitourinary/Reproductive: OHSS: 4/11.4; 2/5.4; Vaginal hemorrhage: 3/8.6; 0/0.0; Ovarian disorder (pain, cyst): 1/2.9; 3/8.1; Urinary tract infection: 0/0.0; 1/2.7; Cervix disorder: 1/2.9; 0/0.0; Gastrointestinal: Nausea: 2/5.7; 0/0.0; Enlarged abdomen: 1/2.9; 1/2.7; Abdominal pain: 1/2.9; 2/5.4; Vomiting: 0/0.0; 1/2.7; Constipation: 0/0.0; 1/2.7; Diarrhea: 0/0.0; 1/2.7; Metabolic/Nutritional: Dehydration: 0/0.0; 1/2.7; Weight gain: 1/2.9; 0/0.0; Skin/Appendages: Acne: 1/2.9; 0/0.0; Exfoliative dermatitis: 0/0.0; 1/2.7; Other Body Systems: Headache: 4/11.4; 3/8.1; Pain: 2/5.7; 0/0.0; Neck pain: 0/0.0; 1/2.7; Respiratory disorder: 2/5.7; 0/0.0; Hot flashes: 2/5.7; 0/0.0; Fever: 0/0.0; 1/2.7; Hypertension: 0/0.0; 1/2.7; Emotional lability: 0/0.0; 1/2.7; Depression: 0/0.0; 1/2.7; Accidental injury: 0/0.0; 1/2.7. Integrated IVF Safety Profile (FPI FSH 99-04, FPI FSH 99-05 and FPI FSH 2001-01 Studies for IVF): All patients with adverse events ≥2% for Bravelle® SC (N=150) were as follows (patients/percent): Genitourinary/Reproductive: Vaginal hemorrhage: 7/4.7; Post retrieval pain: 12/8.0; Pelvic pain/cramps: 10/6.7; OHSS: 9/6.0; Uterine spasms: 4/2.7; Vaginal spotting: 4/2.7; Urinary tract infection: 5/3.3; Ovarian disorder: 3/2.0; Breast tenderness: 3/2.0; Vaginal discharge: 4/2.7; Infection fungal: 3/2.0; Gastrointestinal: Abdominal cramps: 21/14.0; Nausea: 13/8.7; Abdominal pain: 7/4.7; Abdominal fullness/enlargement: 10/6.7; Constipation: 3/2.0; Other Body Systems: Headache: 19/12.7; Pain: 8/5.3; Rash: 4/2.7; Respiratory disorder: 6/4.0; Sinusitis: 3/2.0; Injection site reaction: 6/4.0; Hot flash: 6/4.0; Emotional lability: 3/2.0. The following medical events have been reported subsequent to pregnancies resulting from gonadotropin therapy in published clinical studies: 1) Spontaneous abortion. 2) Ectopic pregnancy. 3) Premature labor. 4) Postpartum fever. 5) Congenital abnormalities. The following adverse reactions have been previously reported during urofollitropin for injection, purified therapy: 1) Pulmonary and vascular complications (see WARNINGS section). 2) Adnexal torsion (as a complication of ovarian enlargement). 3) Mild to moderate ovarian enlargement. 4) Hemoperitoneum. 5) There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established. DRUG ABUSE AND DEPENDENCE: There have been no reports of abuse or dependence with follitropins. OVERDOSAGE: Aside from possible ovarian hyperstimulation (see WARNINGS) and multiple gestations (see WARNINGS), little is known concerning the consequences of acute overdosage with Bravelle®. HOW SUPPLIED: Bravelle® (urofollitropin for injection, purified) is supplied in a sterile, lyophilized, single dose vial containing 82.5 IU of FSH, to deliver 75 IU FSH after reconstituting with the diluent. Each vial is available with an accompanying vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride Injection, USP. 75 IU FSH activity, supplied as: NDC 55566-8505-2: Box of 5 vials + 5 vials diluent NDC 55566-8505-6: Box of 5 vials + 5 vials diluent + 5 Q • Cap vial adapters Lyophilized powder may be stored refrigerated or at room temperature (3° to 25°C/37° to 77°F). Protect from light. Use immediately after reconstitution. Discard unused material. Rx only Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP, manufactured for Ferring Pharmaceuticals Inc. Q • Cap™ manufactured by Bioject Medical Technologies Inc. Tualatin, OR 97062 Manufactured for: FERRING PHARMACEUTICALS INC. PARSIPPANY, 07054 SUFFERN, NYNJ10901 By: CARDINAL HEALTH Albuquerque, New Mexico 87107 6048-04

9/10

6-D6048FR-04

BRV-04124

08/04

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The OB/GYN Nurse AWHONN HIGHLIGHTS

New AWHONN Guidelines for Staffing Perinatal Units Focus on Nurses’ Achievements By Caroline Helwick

ew perinatal staffing guidelines issued by the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) were met with a standing ovation when presented to nurses attending the annual AWHONN meeting. The guidelines were presented by perinatal nurse specialists Linda Schofield, RN, MSN, NEA-BC, of Florida Hospital, Orlando, and Kathleen Rice Simpson, PhD, RNC, FAAN, of St. John’s Mercy Medical Center, St. Louis, MO. “The guidelines are intended to allow you to leave work saying ‘I did good work today,’ rather than worrying about what you could not get done,” Dr Simpson said. “We know you are capable of doing the right things in the right context if you only have enough people.” Ms Schofield echoed her sentiments. “We have been fighting for optimal staffing in perinatal units for years,” she added. “Nurses want to provide the best care possible, but are challenged to do so under existing staffing guidelines.” Previous guidelines from other organizations were developed decades ago

and do not reflect today’s realities, which include more births by cesarean section; frequent use of high-alert medications, such as oxytocin; and increasingly burdensome regulatory and accreditation standards. In addition, previous guidelines were based on medical/surgical patients and did not reflect the “dynamic” clinical environment of perinatal care, she added. “Our variance is much higher. Don’t make me fit perinatal nursing into a med-surg model,” Ms Schofield said, to audience applause. Survey of 900 Nurses Was Basis for Recommendations An AWHONN task force developed the guidelines after surveying almost 900 perinatal nurses about their concerns. “We used open-ended questions to avoid the bias inherent in predetermined content of structured survey items. The care taken and details provided in their responses were amazing,” Dr Simpson noted. The key concepts used for determining safe staffing ratios were classification

“Glimmers of Hope”... working to improve maternal and newborn health. “Know that you are part of this global nursing community,” she said. Having traveled around the world to identify global health needs of women, Dr Mancuso applauded nurses, saying, “I am amazed and awed by the role that nurses and nurse midwives play in healthcare systems everywhere.” Throughout the developing world, mothers and newborns are dying from preventable diseases, she emphasized. “We know how to save their lives, but only a fraction of those in need have been reached,” she said. “My own personal change is to prevent these needless deaths.” Sobering Statistics Every minute, 1 woman dies from pregnancy-related causes worldwide. More than 500,000 die during pregnancy or within 6 weeks of delivery, and 90% of them live in the developing world. This leaves 100 million children motherless and at a 10-fold risk of dying within 2 years compared with their peers, according to Dr Mancuso. Cervical cancer, HIV/AIDS, and malaria remain other areas of concern. Cervical cancer is the leading cause of

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“The guidelines are intended to allow you to leave work saying ‘I did good work today,’ rather than worrying about what you could not get done.” —Kathleen Rice Simpson, PhD, RNC, FAAN

of patients and description of likely clinical situations, she said. The key staffing recommendations are: 1. 1 registered nurse (RN) to 3 antepartum women with complications 2. 1 RN to 1 woman receiving oxytocin for labor induction or augmentation 3. 1 RN to 3 healthy mother–baby couplets. The full recommendations are available online at www.awhonn.org. Examples include: • Couplet care assignments: nurses should not have more than 2 women recovering from cesarean birth on the immediate postoperative day • Assignments that include only new mothers: nurses should not have more than 5 to 6 postpartum women without complications, with no more than 2 to 3 women on the immediate

postoperative day who are recovering from cesarean birth • Assignments that include only babies: 1 nurse should be physically present in the nursery when there are babies in the nursery; nurses should not have more than 5 to 6 newborns requiring routine care. A number of factors make these ratios reasonable, according to Dr Simpson. “In some centers, 50% of births are by cesarean,” Dr Simpson said. “We used to keep these mothers nearly a week. Now they are there a couple of days and there is higher acuity. A 1:3 mother–baby couplet ratio is not okay if they all had cesareans that morning. It’s important to look at the acuity, and the documents contain those details.” Continued on page 10

Continued from page 1

“Improving the health of women and newborns around the world is a goal that is within our reach….I am amazed and awed by the role that nurses and nurse midwives play in healthcare systems everywhere.” —Leslie Mancuso, PhD, RN, FAAN death for women living in developing countries, with nearly 500,000 new cases annually, resulting in 274,000 deaths. Cervical cancer is particularly sinister in the setting of coinfection with HIV/AIDS. In sub-Saharan Africa, 60% of those with HIV are women; therefore, it is necessary to move to a “women-centered approach” in addressing this disease, she said. Malaria claims the lives of 10,000 pregnant women and 200,000 infants each year, and is a risk factor for anemia and low birth weight. Tuberculosis is rampant in many countries as well. Jhpiego Saves Lives Jhpiego prevents these needless deaths, Dr Mancuso said. Founded in

1973, the organization employs more than 700 persons in 54 countries. Jhpiego saves lives by: • Building local human resource capacity • Working in partnership with the government, nongovernmental organizations, universities, professional associations, and communities • Strengthening healthcare systems • Developing evidence-based innovations • Sharing best practices. The organization targets virtually all areas that affect the health of women— family planning, maternal and child health, malaria in pregnancy, cervical cancer prevention, HIV/AIDS, and tuberculosis. The aim is to provide a “household-to-hospital continuum of

care” in the developing world, and many innovative approaches are helping to accomplish this. For example, in a village in Kenya, nurses organized a “women’s reproductive health camp” that drew 450 women in a single day to be screened for and counseled about HIV and cervical cancer. The camp used the “single-visit approach” that is emerging as an effective means of cervical cancer screening in the developing world. Nurses use acetic acid to visually inspect the cervix and treat lesions immediately with cryotherapy. In Thailand, 450 health professionals have been trained in the single-visit approach; 500,000 women have been screened, and more than 2600 have been treated. Other innovative approaches have included community-based distribution of misoprostol (3-pill pack) to prevent postpartum hemorrhage and calcium “sprinkles” to prevent preeclampsia. “I have traveled around the world meeting with nurses and midwives who are working to improve healthcare, and I can tell you, there have been enormous accomplishments,” she concluded. “Despite the challenges, we see glimmers of hope.” ■

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The OB/GYN Nurse AWHONN HIGHLIGHTS

Nurses Introduce Oxytocin Checklist to Push “the Pit” Safely and Effectively By Caroline Helwick

ow you administer oxytocin to push “the pit” matters, according to Jill H. Mahony, MSN, APN, WHNP-BC, RNC-OB, a perinatal clinical nurse specialist, and Deborah Moorhouse, BSN, RN-BC, a staff registered nurse (RN), Capital Health System, Trenton, NJ. They presented at the Association of Women’s Health, Obstetric and Neonatal Nurses annual meeting a new checklist they use at their tertiary perinatal center to ensure the safe administration of this high-risk drug. They followed a protocol developed by Clark and colleagues (Am J Obstet Gynecol. 2007;197:480.e1-480.e5) to determine if it would help improve maternal and fetal outcomes. “We wanted to use a checklist to make induction and labor safer,” Ms Mahony said. “Oxytocin is a high-risk medication and not a numbers game. Without a standardized approach, you are throwing the dice. The risk is fetal deoxygenation and possible compromise.” The leading cause of obstetric liability is oxytocin administration leading to hyperstimulation and fetal injury. “This is completely preventable,” she said. “And it is part of the inspiration for our research.” Ms Mahony explained that the therapeutic index of oxytocin is complex. In the presence of higher doses, the drug’s half-life shortens. When it comes to oxytocin, “less is more,” she emphasized. “Most women at term have a successful induction with 6 mU/min or less.” You want to achieve a steady state in which the rate of administration equals the rate of elimination. The necessary time interval to achieve a steady state with the recommended physiologic regimen is at least 30 to 40 minutes. If the

dose is increased before a steady state is achieved, uterine tachysystole and fetal decompensation can occur. “You have to balance the amount [of oxytocin] needed to cause contractions with the amount that will cause toxicity,” she said. “Few drugs are so unpredictable. Before you increase the dose, you need evidence that your current rate is ineffective.”

—Jill H. Mahony, MSN, APN, WHNP-BC, RNC-OB

Oxytocin Management Checklist “The oxytocin checklist is not intended to hinder progress in labor, but to enhance the safe use of oxytocin,” Ms Moorhouse added. It also helps the labor nurse maintain established criteria for safe titration, promotes critical thinking, and improves collaborative communication among the obstetrical team. Before administering oxytocin, the nurse first assures that several factors have been documented in the chart— order, history and physical, and prenatal record; gestational age; indication for induction; adequacy of pelvis; cervical examination; vertex presentation; estimated fetal weight by clinical examination or ultrasound; signed consent; and awareness of physician, who is readily available. The nurse makes sure that in the previous 30 minutes the fetal heart rate pattern has shown at least 1 of the following:

Check each box only if the answer is “yes”

Time

1 acceleration of 15 bpm ⳯ 15 sec in 30 min OR Moderate variability for 10 min of previous 30 min No more than 1 late deceleration has occurred No more than 2 variable decelerations >60 sec in duration and decreasing >60 bpm from baseline

Uterine No more than 5 uterine contractions in 10 min for any 20-min interval No 2 contractions >120 sec in duration Uterus palpates soft between contractions If IUPC is in place, MVU must calculate <300 mm Hg and baseline resting tone must be <25 mm Hg bpm indicates beats per minute; IUPC, intrauterine pressure catheter; MVU, Montevideo units.

october 2010 I Vol 2, No 5

every 30 minutes, assesses maternal– fetal status every 15 minutes, and documents every change in dosage. If there is no change, this is noted every 30 minutes as well. If the oxytocin is stopped, another preoxytocin checklist must be completed before it is restarted. Since instituting the protocol, the nurses have used a lower initial oxytocin dose, starting at 1 mU/min and increasing by 2 mU/min every 30 minutes. The checklist is now mandatory for all physicians, nurse midwives, and labor-skilled RNs at their center. Outcomes have improved with the institution of this checklist, Ms Mahony reported. The length of labor and cesarean rates have not increased, and mean peak doses of oxytocin have decreased significantly. In addition, mean episodes of nonintervened uterine tachysystole have declined significantly, from 1.4 mU/min to 0.5 mU/min, she said. “We use less oxytocin for an effective delivery,” Ms Mahony said. “We believe the protocol-driven safety checklist for oxytocin administration should be used for every labor induction and augmentation. ■

“You have to balance the amount [of oxytocin] needed to cause contractions with the amount that will cause toxicity. Few drugs are so unpredictable.”

Management Checklist for Oxytocin Dosing

Fetal

• ≥2 Accelerations (15 bpm ⳯ 15 sec) OR • A biophysical profile of 8/10 within the past 4 hours OR • Moderate variability. There must also be no late decelerations and ≤2 variable decelerations >60 seconds and decreasing >60 bpm from baseline. If these cannot be veri-

fied, then the preoxytocin checklist cannot be completed and the drug cannot be initiated. Once oxytocin is started, the ongoing management checklist is used to ensure safe administration (Box). If any of the assessment criteria cannot be satisfied for the previous 30-minute time-frame, then the oxytocin rate cannot be increased. “There are no exceptions,” Ms Moorhouse stressed. The nurse completes this checklist

New AWHONN Guidelines... Continued from page 9 Other Recommendations The guidelines also contain staffing recommendations for antepartum testing (1 RN to 2-3 women during nonstress testing), obstetrical triage (1 RN to 2-3 women after initial assessment and in stable condition), and cervical ripening (1 RN to 2 women), and they clarify high-risk status and obstetric and medical complications, recommending 1 RN to 1 woman in labor with such complications. The new recommendations allow for the inclusion of lactation consultants— 1.9 full-time staff for every 1000 births in level 3 perinatal centers, 1.6 in level 2 centers, and 1.3 in level 1 centers. The critical elements of postpartum recovery and the number of nurses needed for each step are also included, as well as recommendations for contingency planning. “We felt that during the immediate postpartum recovery period, there should be 1 nurse for the mother and 1 nurse for the baby,” Dr Simpson said. “When both are sta-

ble, and critical elements of recovery have been met (listed in detail in the document), 1 nurse can care for both. You cannot accept another patient until this occurs.” Finally, AWHONN recommends that 2 RNs be on board even when there are no perinatal patients, so that women presenting with obstetric emergencies can be attended to safely. Contingency plans should be in place to cover situations when existing staffing is inadequate, and elective procedures should be deferred until nursing staff are adequate. “This may include discontinuing the oxytocin infusion for women having elective labor induction. When other patients are coming in, shut off the pit,” she said, as the nurses cheered. Although these staffing improvements cannot be implemented immediately, they should be incorporated into planning now, she said. “In 12 to 18 months, you may be able to do this,” Dr Simpson predicted. ■

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OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 11

The OB/GYN Nurse AWHONN HIGHLIGHTS

Preeclampsia Can Be Predicted by 2 Variables By Caroline Helwick

wo second-trimester variables can predict the development of preeclampsia in the third trimester, according to a study that earned the Outstanding Research Paper Award at the Association of Women’s Health, Obstetric and Neonatal Nurses annual meeting. “It seems that something earlier in pregnancy must be happening before blood pressure becomes that magic number that nurses look for—140/90 mm Hg,” said Rita J. Nutt, DNP, RN, of Salisbury University, MD.

motensive. In other words, 32 of the 36 women who had preeclampsia did not have this drop in BP. “This study showed that changes in blood pressure seen in preeclamptic patients predate the time-frame—late pregnancy—when preeclampsia is historically diagnosed,” she said.

Practical Implications Dr Nutt offered the following recommendations to nurses: • Consider BP in the context of the entire patient profile • Use only licensed nursing staff to obtain measurements • Record and evaluate BP carefully

• Track BP numerically and graphically in a format that takes into account the gestational period • Counsel women regarding weight gain, with special consideration paid to overweight and obese women. “Some risk factors, like race, first pregnancy, and age, we cannot control,” Dr Nutt said. “But the findings indicate that maybe we can lower the risk by controlling weight gain.” ■

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—Rita J. Nutt, DNP, RN

To explore patient characteristics as predictors of preeclampsia, Dr Nutt used a retrospective case-control model to compare second-trimester blood pressure (BP) rates of women who developed preeclampsia (n = 36) with those of women who remained normotensive (n = 108) in a single obstetrical practice within a tertiary care medical center. Dr Nutt looked at the normal physiologic 10-mm Hg drop in diastolic BP that usually occurs in the second trimester. Her hypothesis was that a failure to experience this anticipated drop might increase the likelihood of developing preeclampsia. The patients’ second-trimester BP measurements were averaged, and this number was compared with the initial prenatal visit reading to ascertain whether the physiologic drop occurred. “We found that women who did not experience this BP drop were almost 9 times more likely to develop preeclampsia,” Dr Nutt reported. “We also found that weight gain in excess of the guidelines based on body mass index [BMI] was associated with nearly a 3-fold increased risk.” The adjusted odds ratios for preeclampsia were 8.8 for the lack of a diastolic BP dip and 2.8 for weight gain above the recommendation. For overweight women, the risk was increased 5fold. Initial diastolic pressure and BMI were not associated with the development of preeclampsia. The model correctly predicted 78.5% of preeclampsia cases, she said. The study showed that 36.8% of the women who did not have the anticipated BP drop progressed to preeclampsia, unlike the 63.2% of women who remained nor-

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october 2010 I Vol 2, No 5

OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 12

The OB/GYN Nurse

Psychological Violence by Partner during Pregnancy a Risk for Postpartum Depression By Wayne Kuznar

omen who report psychological violence by their intimate partners during pregnancy are more likely to develop postpartum depression than those not subjected to such violence, Brazilian researchers found (Ludermir AB, et al. Violence against women by their intimate partner during pregnancy and postnatal depression: a prospective cohort study. Lancet. 2010;376:903-910). The association remained even when psychological violence occurred without physical or sexual violence. Psychological violence is often overlooked by healthcare professionals because of the emphasis placed on

TAKEAWAY QUICK POINTS ➤ Many pregnant women experience psychological, physical, or sexual violence from their partner. ➤ Only a few of them volunteer this information to their healthcare provider, unless asked directly. ➤ Nurses may need to consider screening for violence as part of a pregnancy evaluation.

physical and sexual violence by intimate partners, the researchers wrote. Women were interviewed during pregnancy and after delivery. A total of 1045 women who completed their pregnancy and postnatal interviews were included in the analysis. Of these women, 321 (30.7%) reported some type of partner violence during their pregnancy, with the most common being psychological violence (n = 294), followed by physical violence (n = 123) and sexual violence (n = 60). Positive answers to any of the following interview questions constituted psychological violence: • Has he insulted you or made you feel bad about yourself? • Has he belittled you in front of other people? • Has he done things to scare or intimidate you on purpose? • Has he threatened to hurt you or someone you care about? A psychological violence score, ranging from 0 to 12, was calculated based on the frequency of each act of violence. Postpartum depression was assessed using the Edinburgh Postnatal Depression Scale, which consists of 10 items rated on a scale of 0 to 3.

More than half (53%) the women who reported physical or sexual violence plus psychological violence dur-

“It makes sense that women living in abusive relationships are more depressed.” —Cyndi Roller, PhD, RN, CNP, CNM

ing pregnancy had postpartum depression. Of those who reported psychological violence alone, 39% had postpartum depression; after adjusting for confounding factors (history of mental illness and self-reported mental disorders during pregnancy), psychological violence alone doubled the risk of postpartum depression. As the psychological violence score increased, the likelihood of depression increased. Physical or sexual violence alone did not appear to be associated with depression. The researchers noted, however, the large overlap

between types of violence reported; of the 147 women who were physically or sexually abused, only 27 did not also report psychological violence. The researchers call for interventions to prevent psychological violence but admit that evidence for improvement through typical interventions (ie, referral to shelters, transitional housing, legal advice, and psychological support) is lacking. “It makes sense that women living in abusive relationships are more depressed,” and that this depression becomes worse postpartum, commented Cyndi Gale Roller, PhD, RN, CNP, CNM, Program Director, Women’s Health, Kent State University College of Nursing, Kent, OH. She noted that screening for violence is not routinely done in prenatal care, although it should be. “I have screened patients for violence, including sexual violence, and I will hear, ‘nobody has ever asked me those questions,’ so this tells me that people aren’t doing it,” Dr Roller said. Many women who are victims of psychological violence grew up being emotionally abused, she added, and they often do not recognize verbal abuse. ■

Desvenlafaxine Safe, Effective for Major Depression during Perimenopause and Menopause By Richard Hyer

erimenopause and menopause are often accompanied by major depression. Now results from the first study to target depression during that transition period in women have shown that the antidepressant desvenlafaxine (Pristiq) can safely relieve this condition (Kornstein SG, et al. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010;71:1088-1096). The study included 387 perimenopausal and postmenopausal women (aged 40-70 years) across 37 centers in the United States. Lead investigator Susan G. Kornstein, MD, Professor of Psychiatry and Obstetrics/Gynecology, and Executive Director, Institute for Women’s Health, Virginia Commonwealth University, Richmond, said, “This was the first large study to demonstrate the efficacy of an antid epressant specifically in peri- and postmenopausal women.”

october 2010 I Vol 2, No 5

“This was the first large study to demonstrate the efficacy of an antidepressant specifically in peri- and postmenopausal women.” —Susan G. Kornstein, MD

Women are at greater risk for major depressive disorder (MDD) than men, and a woman’s risk for depression increases during perimenopause. According to Dr Kornstein’s study, women entering menopause are twice more likely to develop new-onset depression than premenopausal women of the same age. In a previous analysis of 9 trials, Dr Kornstein and colleagues found that the selective serotonin and norepinephrine reuptake inhibitor desvenlafaxine improved functioning and well-being in patients suffering from MDD. The current study was designed to measure the effectiveness of this antidepressant for treating MDD,

specifically in perimenopausal and postmenopausal women. All 387 women met the criteria for MDD. They were randomized to desvenlafaxine or to placebo for 8 weeks, with the option of a 6-month open-label extension period after the trial. In the active drug group, a daily dose of 100-mg or 200-mg desvenlafaxine was prescribed at the investigator’s discretion. The results showed desvenlafaxine to be effective and generally well-tolerated in this patient population, based on the 17-item Hamilton Depression Rating Scale, as well as secondary measures. Patients treated with desvenlafaxine had significantly greater

response rates compared with the placebo group—58.6% versus 31.6%, respectively (P <.001). Dr Kornstein said that she and her colleagues did not have data to answer how long to treat a patient with desvenlafaxine. “I would use as a guide what we know about how to treat other episodes of major depression, which is for at least an additional 4 to 9 months after the symptoms are in remission, and possibly long-term if the patient has had a chronic or recurrent course of depression,” she said. Perimenopausal depression is sometimes treated with estrogen, but it has not been shown to be effective for postmenopausal depression. “Both patients and doctors are reluctant to use it [estrogen] since the Women’s Health Initiative results,” said Dr Kornstein. Estrogen may increase the risk for breast cancer, coronary heart disease, stroke, and dementia. Antidepressants are the first-line treatments for MDD, she said. ■

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OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 13

Because patients trust your knowledge...

Progesterone # Fact 5

Vis it u Bo s a oth t A #4 SRM 33

Only one progesterone is FDA approved for progesterone replacement. Itâ&#x20AC;&#x2122;s a fact. When patients are undergoing donor egg cycles, only CRINONE offers the confidence of FDA approval for progesterone replacement.1 In fact, CRINONE has demonstrated comparable pregnancy rates to IM P in a prospective, randomized trial of women in a donor egg cycle.2 When she asks about progesterone, give her the facts.

The only ONE CRINONE 8% (progesterone gel) is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency. Important Safety Information The most common side effects of CRINONE (progesterone gel) 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8% is contraindicated in patients with active, or a history of, thrombophlebitis or thromboembolic disorders, patients who have known sensitivity to CRINONE 8%, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. Should any of the earliest manifestations of thrombotic disorders occur, the drug should be discontinued immediately. No evidence is available to show that progesterone and progestins are effective in preventing miscarriage in women with a history of recurrent spontaneous pregnancy losses. The pretreatment physical exam should include special reference to breast and pelvic organs as well as a Papanicolaou smear. Nonfunctional causes of breakthrough bleeding should be considered, and for undiagnosed vaginal bleeding, diagnostic measures should be undertaken. Special care should be taken with patients who have conditions that may be influenced by fluid retention, those who have a history of psychic depression, and those with diabetes. Please see brief summary of full prescribing information on the following page. Toll-free support line: 1-888-PRO-GEL8 (1-888-776-4358) ÂŠ 2010, Watson Laboratories, Inc.

OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 14

The OB/GYN Nurse

Bariatric Surgery Lowers Risk for Hypertension in Subsequent Pregnancies By Wayne Kuznar

bese women who underwent bariatric surgery had a much lower risk for hypertensive complications during subsequent pregnancies, according to a recent study (Bennett WL, et al. Impact of bariatric surgery on hypertensive disorders in pregnancy: ret-

rospective analysis of insurance claims data. BMJ. 2010;340:c1662). Chronic hypertension complicating pregnancy is associated with adverse perinatal outcomes, including preterm birth and intrauterine growth restriction, the study researchers noted. They

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october 2010 I Vol 2, No 5

examined claims data of 585 American pregnant women (aged 16-45 years) who had undergone bariatric surgery. Of these women, 269 delivered before their bariatric surgery and 316 delivered after surgery. Preeclampsia or eclampsia occurred

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in 14.5% of the women who delivered before bariatric surgery compared with 2.5% who delivered after the surgery. Mild preeclampsia, the most common diagnosis, occurred in 8.6% of women who delivered before surgery compared with only 1.9% who delivered after surgery.

Rates of any hypertensive disorder in pregnancy were substantially lower among those who delivered after surgery versus those who delivered before surgery. Rates of any hypertensive disorder in pregnancy were substantially lower among those who delivered after surgery versus those who delivered before surgery (odds ratio [OR], 0.25). Specifically, lower ORs were found for gestational hypertension (OR, 0.16), preeclampsia or eclampsia (OR, 0.20), and chronic hypertension complicating pregnancy (OR, 0.39). The researchers noted that bariatric surgery could be considered in the preconception management of childbearing-age women who have a body mass index â&#x2030;Ľ40 kg/m2 (or â&#x2030;Ľ35 kg/m2 with comorbidities). In June 2009, the American College of Obstetricians and Gynecologists published clinical management guidelines for bariatric surgery and pregnancy (American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol. 2009;113: 1405-1413). The guideline includes contraceptive counseling after bariatric surgery and addresses nutritional status during pregnancy in women who have undergone bariatric surgery, because nutrient deficiencies can occur after restrictive surgery. Medication dosages may also have to be adjusted after bariatric surgery because of malabsorption, the report states. â&#x2013;

See pages 9-11 for coverage from the 2010 annual meeting of the Association of Womenâ&#x20AC;&#x2122;s Health, Obstetric and Neonatal Nurses.

' D /7-7

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OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 15

Pharmacy Corner

Treatment Options for Nausea and Vomiting during Pregnancy

Figure Suggested Evaluation and Treatment of Women with NVP Pregnant woman presenting with nausea and vomiting ➤

Thorough history and comprehensive physical examination ➤

Positive finding of a nonpregnancy cause

Negative findings

➤

Dietary and lifestyle changes

➤

Sandra Fernandez, PharmD Pharmacist, Mandell’s Clinical Pharmacy, Somerset, NJ

Treat cause ➤

No resolution

Resolution

➤

Pyridoxine ± Doxylamine Acupressure Ginger ➤

➤

Resolution

➤

Dehydration

No dehydration ➤

Antihistamines, anticholinergics, phenothiazines, benzamides, serotonin antagonists, corticosteroids

➤

IV fluids with multivitamins

No resolution

Resolution

➤

Consider TPN

No resolution

Resolution

➤

tains folic acid, calcium, and iron. Although NVP treatment typically begins with nonpharmacologic therapy, providers should be aware that adequate symptom relief is generally achieved with a combination of nonpharmacologic and pharmacologic therapies. ■

No resolution

➤

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➤

ausea and vomiting of pregnancy (NVP), better known as “morning sickness,” is one of the cardinal signs of early pregnancy, affecting approximately 80% of all pregnant women. NVP generally begins in the fifth week after the last menstrual period and resolves by the twentieth week of gestation for most women. A small percentage of women will experience symptoms throughout their entire pregnancy. Pregnant women who present to their physician with NVP should undergo a thorough history and a comprehensive physical examination to rule out any other potentially serious causes. If the examination findings suggest a specific cause, testing is necessary to confirm the cause. Women with uncomplicated NVP should be treated based on the severity of symptoms. Mild cases may be treated with dietary and lifestyle changes; more severe cases may require pharmacologic therapies to resolve their symptoms. Dietary and lifestyle changes are considered first-line therapy for women who present with mild NVP. Affected pregnant women should be instructed to eat frequent and small meals and to avoid fatty foods, strong odors, triggers, and an empty stomach. Because sleep requirements increase during pregnancy and fatigue may exacerbate NVP, providers should encourage patients to increase their rest, especially when they are symptomatic. Many pregnant women turn to alternative therapies, such as ginger, acupuncture, or acupressure, to treat their NVP, because of growing concerns about adverse effects of drugs during fetal development. When conservative therapies have not been effective, pharmacologic intervention is deemed necessary (Table). The algorithm outlines the suggested evaluation and treatment of women presenting with NVP (Figure). Overall, the management of NVP depends on the severity of the patient’s symptoms and the safety of the developing fetus. Treatment of NVP can and should be handled safely and effectively. All women of childbearing age should be advised to supplement their diet with a prenatal vitamin that con-

IV fluids with multivitamins IV indicates intravenous; NVP, nausea and vomiting of pregnancy; TPN, total parenteral nutrition. Adapted from Quinlan JD, Hill DA. Nausea and vomiting of pregnancy. Am Fam Physician. 2003;68:121-128.

Table Pharmacologic Therapies for Nausea and Vomiting during Pregnancy Drug class/name

Dose

Major side effects

FDA pregnancy category

Antihistamines, anticholinergics Diphenhydramine (Benadryl)

25-50 mg every 4-6 hrs

Drowsiness

Dimenhydrinate (Dramamine)

50-100 mg every 4-6 hrs

Drowsiness

Doxylamine (Unisom)

25 mg/d

Meclizine (Antivert)

25 mg every 4-6 hrs

Aa, Cb Drowsiness

Phenothiazines Prochlorperazine (Compazine)

5-10 mg every 4-6 hrs

Promethazine (Phenergan)

12.5-25 mg every 4-6 hrs

Chlorpromazine (Thorazine)

10-25 mg 2-4 times daily

Sedation; anticholinergic effects; severe hypotension if used parenterally Sedation; anticholinergic effects; severe hypotension if used parenterally Sedation; anticholinergic effects; severe hypotension if used parenterally

C C C

Benzamides Metoclopramide (Reglan)

5-10 mg every 8 hrs

EPS; anxiety; dystonic reactions

Headache

0.625-2.5 mg IV or IM every 3-4 hrs

EPS; QT prolongation

16 mg 3 times daily

Adrenal insufficiency w/ abrupt withdrawal after long-term therapy

Serotonin antagonists Ondansetron (Zofran)

4-8 mg 3 or 4 times daily

Butyrophenones Droperidol (Inapsine) Corticosteroids Methylprednisolone (Medrol) Vitamin Pyridoxine (vitamin B6) a Per b

Ac, Cd

25 mg 3 times daily c As d

Briggs’ Drugs in Pregnancy and Lactation. a vitamin supplement. Per manufacturer recommendations. Dose exceeding recommended daily allowance. EPS indicates extrapyramidal symptoms; IM, intramuscular; IV, intravenous; FDA, Food and Drug Administration.

october 2010 I Vol 2, No 5

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CONTINUING EDUCATION

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PROGRAM CNE003 • RELEASE DATE: OCTOBER 15, 2010 • EXPIRATION DATE: OCTOBER 15, 2011 ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Recognition and Management of Ectopic Pregnancy By Debra Moynihan, WHNP-BC, MSN Nurse Practitioner, Women’s Health, and Clinical Director, Carolina OB/GYN, Murrells Inlet, SC STATEMENT OF NEED Ectopic pregnancy is the leading cause of maternal mortality during the first trimester, and it accounts for 9% of all pregnancy-related deaths. Ectopic pregnancy can be difficult to diagnose, because symptoms often mirror those of a normal early pregnancy. Early diagnosis may allow medical management and avoid the need for surgical intervention. Appropriate screening of patients and risk assessment by obtaining a complete history, a physical examination, and assessing the patient’s sexual activity can lead to early diagnosis and proper counseling. TARGET AUDIENCE Nurses whose primary interest is women’s health and infertility. LEARNING OBJECTIVES After completing this activity, the reader should be able to: • Describe patient-associated risk factors that may contribute to experiencing a tubal pregnancy • Discuss the signs and symptoms used for making a differential diagnosis of ectopic pregnancy • Review the medical management of ectopic pregnancy, including contraindications, side effects, and dosing considerations

ctopic pregnancy refers to any pregnancy that lies outside the uterus. Ectopic pregnancies occur in approximately 20 (2%) of every 1000 births.1 Ectopic pregnancy is the leading cause of maternal mortality during the first trimester, and it accounts for 9% of all pregnancy-related deaths.1 Although ectopic pregnancy–related mortality in the United States has decreased over the years, the actual number of ectopic pregnancies has increased. Between 1970 and 1992, the ectopic pregnancy rate increased from 4.5 to 19.7 per 1000 reported pregnancies.2,3 This includes live births, legal abortions, and ectopic pregnancies.

Tubal Pregnancy Implantation of a fertilized ovum usually occurs within the uterus in a normal pregnancy. In an ectopic pregnancy, the fertilized ovum may implant in a variety of sites, including an ovary (rare), the cervix, the abdomen, or most common, the fallopian tube. Tubal pregnancy occurs in approximately 95% of ectopic pregnancies.4 Some of the contributing factors are previous ectopic pregnancy, endometriosis, structural defects of the fallopian tubes, and

CONTINUING NURSING EDUCATION ACCREDITATION AND CONTACT HOURS STATEMENT Science Care is approved by the California Board of Registered Nursing, Provider number 15559, for 1.0 contact hour. METHOD OF PARTICIPATION 1. Read the article in its entirety 2. Go to www.obgyn-infertility-nurse.com 3. Select “Continuing Education” 4. Click on this article’s title from the list shown 5. Select “Click here to complete the posttest and obtain a CE certificate online” 6. Complete and submit the CE posttest and CE Activity Evaluation 7. Print your Certificate of Credit This activity is provided free of charge to participants. FACULTY DISCLOSURES As a provider accredited by the California Board of Registered Nursing, Science Care must ensure balance, independence, objectivity, and scientific rigor in all its activities. All course directors, faculty, planners, and any other individual in a position to control the content of this educational activity are required to disclose to the audience any relevant financial relationships with any commercial interest. Science Care must determine if the faculty’s relationships may influence the educational content with regard to exposition or conclusion and resolve any conflicts of interest prior to the commencement of the educational activity. Disclosures are as follows:

october 2010 I Vol 2, No 5

prior tubal surgeries, such as tubal reversal and bilateral tubal ligation. Ectopic pregnancy is more likely to occur ≥2 years after tubal ligation than immediately after the procedure. If pregnancy occurs in the first year, 6% of pregnancies will likely be ectopic; however, most ectopic pregnancies occur 2 to 3 years after tubal ligation.5

Between 1970 and 1992, the ectopic pregnancy rate increased from 4.5 to 19.7 per 1000 reported pregnancies. This includes live births, legal abortions, and ectopic pregnancies. Fifty percent of tubal pregnancies are related to previous infection of the fallopian tubes. Infections such as chlamydia and gonorrhea, which can lead to pelvic inflammatory disease (PID), can cause scarring of the tubes, which will affect transport of a fertilized ovum. The rate of ectopic pregnancy is 6 to 10 times higher in women with a

• Debra Moynihan, WHNP-BC, MSN, is a consultant and nurse educator for Mandell’s Pharmacy. • Meike L. Uhler, MD, has nothing to disclose. • Dalia Buffery, MA, ABD, has nothing to disclose. • The staff members of Science Care have nothing to disclose. DISCLAIMER The opinions and recommendations expressed by faculty, authors, and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of Science Care or Novellus Healthcare Communications, LLC. COPYRIGHT STATEMENT Copyright © 2010 Science Care. All rights reserved. EDITORIAL BOARD Debra Moynihan, WHNP-BC, MSN Nurse Practitioner, Women’s Health Clinical Director, Carolina OB/GYN 242 Willow Bay Drive, Murrells Inlet, SC 29576 Meike L. Uhler, MD Reproductive Endocrinology and Infertility Fertility Centers of Illinois 2056 Westings Avenue, Suite 130, Naperville, IL 60563 Clinical Associate Professor Division of Reproductive Endocrinology and Infertility Department of Obstetrics and Gynecology Loyola University Stritch School of Medicine 2160 S. First Avenue, Building 103, Maywood, IL 60153

history of PID than in those without a history of PID.4 A review published in 2010 supports the hypothesis that tubal pregnancy is caused by a combination of retention of the embryo within the fallopian tube resulting from an impaired embryotubal transport and alterations in the tubal environment allowing early implantation to occur.6 Other populations at risk include women1: • Who have undergone in vitro fertilization • Using an intrauterine device with progesterone • Taking the “mini” pill • Who smoke cigarettes • Who are at increased maternal age (35-44 years) • With ruptured appendix. Signs and Symptoms As with most pregnancies, women with an ectopic pregnancy may exhibit the same signs of early pregnancy as those with a normal or intrauterine pregnancy, such as nausea and vomiting, breast tenderness, and urinary frequency.7 The first sign of an ectopic pregnancy is usually amenorrhea7; however, it is not uncommon to have some vaginal bleeding or spotting in the first trimester. If this bleeding is associated with lower abdominal pain, the patient needs to be evaluated immediately to rule out ectopic pregnancy. Early diagnosis will not only save the patient’s life but will increase her chances of preserving her fertility. An ectopic pregnancy should always be considered in any woman of childbearing age who reports mild or severe abdominal symptoms.7 Initially, the pain may be unilateral; as the pregnancy progresses, however, it can become more sharp and severe, and the patient may complain of a more generalized discomfort. Other associated symptoms include malaise, syncope, and gastrointestinal disturbances. The patient may also present with tachycardia, hyperpnea, hypotension, and/or a rigid abdomen.7 Sometimes the presentation may be atypical. A patient may report vague or subacute symptoms. Amenorrhea may not be obvious because of spotting, which may mimic a normal menses. In some cases, the symptoms do not correlate with the severity of the condition.

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The most classic symptom is Kehr’s sign, which presents as pain radiating to the shoulder. This may indicate abdominal bleeding, which is causing phrenic nerve irritation. Abdominal bleeding leads to shock, and this is the first symptom of ectopic pregnancy in 20% of patients.1 The Table outlines the clinical manifestations of ectopic pregnancy. Diagnosis A physical examination may reveal unilateral tenderness in the adnexa. On pelvic examination, the cervix will appear normal, but there will most likely be marked tenderness. The uterus may be slightly enlarged and soft. There may be vaginal tenderness and blood in the vaginal vault. Depending on gestational age, diagnosis is made by the use of serial quantitative beta-human chorionic gonadotropin (hCG) levels and pelvic ultrasound. In early pregnancy, the beta-hCG levels should double every 48 to 72 hours. Low or abnormally rising levels are suggestive of ectopic pregnancy. If levels are >1500 to 2000 mIU/mL at 35 days gestation and the pregnancy is intrauterine, a gestational sac should be present.8 At presentation, more than 50% of patients with ectopic pregnancy have beta-hCG levels <2000 mIU/mL, which sometimes makes it difficult to determine whether an empty uterus reflects an early pregnancy or an ectopic pregnancy.8 Absence of a gestational sac is suggestive of an ectopic pregnancy. A pseudosac is seen in 10% to 20% of ectopic pregnancies.4 A pseudosac is a sac in the uterus that is not a pregnancy, but that can initially look like one.4 The observer must be able to detect a yolk sac, fetal pole, or cardiac activity to rule out ectopic pregnancy. A culdocentesis can also be performed. If there is nonclotted blood in the cul-de-sac, this generally indicates hemorrhage. The differential diagnosis includes intrauterine pregnancy, recent spontaneous abortion, ovarian cyst or tumor, acute appendicitis, PID, ovarian torsion, or urinary calculi.8 No detectable sonographic abnormality is seen in 20% to 30% of ectopic

Table Clinical Presentation of Ectopic Pregnancy Presentation

Frequency, %

Amenorrhea

60-85

Vaginal bleeding

55-84

Abdominal pain

50-100

Rebound tenderness

40-50

Adnexal mass

30-70

Source: Johnson BE, Johnson CA, Murray JL, et al, eds. Women’s Health Care Handbook, 2nd edition. Philadelphia, PA: Hanley & Belfus; 2000:143.

CONTINUING EDUCATION

COMMENTARY

Advances in the Management of Ectopic Pregnancy Meike L. Uhler, MD Reproductive Endocrinology and Infertility, FCI, Naperville, IL, and Clinical Associate Professor, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Loyola University Stritch School of Medicine, Maywood, IL

wo recent advances have helped to change the prognosis and management of ectopic pregnancy—early diagnosis and medical management. Prompt diagnosis of ectopic pregnancy is now possible thanks to the combination of very sensitive human chorionic gonadotropin (hCG) assay and high-resolution transvaginal ultrasonography. With a discriminatory zone of approximately 1000 to 1200 for hCG and early obstetric ultrasound, an intrauterine pregnancy can be verified

pregnancies.4 Usual findings include a mass on one side, fluid in the pelvis, and no normal pregnancy structures in the uterus.4 Treatment Once the diagnosis of ectopic pregnancy is confirmed, treatment must be initiated immediately to avoid rupture of the tube and hemorrhage. Choice of treatment depends on gestational age, symptoms, location of implantation, and whether the fallopian tube is intact or ruptured. Medical Management: Methotrexate Therapy If the patient is in the very early stage of pregnancy, medical management is the preferred option as opposed to surgery. This is achieved with the use of methotrexate, which is a chemotherapeutic agent that clears the trophoblastic tissue.9 It usually takes 4 to 6 weeks for the pregnancy to be absorbed after treatment with methotrexate.10 The necessary criteria for the use of methotrexate in pregnancy are1: • The patient must be hemodynamically stable • The mass must be unruptured and <4 cm diameter • The patient should not have any contraindications to methotrexate, and she must be reliable in committing to follow-up care. The contraindications to using this method include1: • Known sensitivity to methotrexate • Breastfeeding • Hematologic abnormalities, including severe anemia, thrombocytopenia, or leukopenia

by 5.5 to 6 weeks.1 In the absence of a gestational sac in the uterus by 6 weeks, an ectopic pregnancy is very likely. The patient can be managed safely and effectively with intramuscular methotrexate, which has an 85% to 90% success rate,2 thereby avoiding the need for surgery. Appropriate candidates for methotrexate therapy include patients who have asymptomatic small adnexal mass and, preferably, hCG levels <5000.3 About 10% to 15% of patients will need a second injection of methotrex-

• Alcoholism or evidence of chronic liver disease • Immunodeficiency states (eg, HIV) • Renal or active pulmonary disease • Peptic ulcer disease. Side effects. Common side effects with methotrexate therapy include abdominal cramping for 2 to 3 days, vaginal bleeding or spotting, nausea and vomiting, fatigue, lightheadedness, headache, body aches, and low-grade fever.9 Severe side effects during shortterm therapy with methotrexate are uncommon; these include alopecia, photosensitivity, stomatitis, hepatotoxicity, pulmonary fibrosis, and bone marrow suppression.9 The patient should be instructed to stop prenatal vitamins and all sources of folic acid and alcohol. She should also refrain from having intercourse. She may want to avoid gas-forming foods temporarily to prevent additional abdominal cramping. Penicillin and nonsteroidal anti-inflammatory drugs should be used with caution, because they may delay the excretion of methotrexate from the kidneys. The patient will also benefit from decreased sun exposure. Initial treatment. Methotrexate is a category X drug and may be the initial treatment of choice for most women, but it is not necessarily the best option in all cases. It offers an option to avoid surgery and anesthesia, but some women may still prefer surgical treatment. If treating the patient with methotrexate, it is suggested that the patient wait at least 2 menstrual cycles, or approximately 3 months from the injection, before trying to conceive again. Methotrexate may interfere

ate if the hCG levels plateau or increase, but less than 10% of patients will need surgery.3 The high success rate and minimal side effects associated with methotrexate make it the preferred treatment for stable patients with early diagnosis of ectopic pregnancy. ■ References 1. Lindheim SR, Uhler ML. Pelvic ultrasonography and sonohysterography. In: Falcone T, Hurd W, eds. Clinical Reproductive Medicine and Surgery. Philadelphia, PA: Mosby/Elsevier; 2007:441-459. 2. Barnhart KT. Clinical practice: ectopic pregnancy. N Engl J Med. 2009;361:379-387. 3. The Practice Committee of the American Society for Reproductive Medicine. Medical treatment of ectopic pregnancy. Fertil Steril. 2008;90:S206-S212.

with the cells of a developing pregnancy in a negative way and could cause birth defects.9 Dosing. The dosing of methotrexate is 50 mg/m2 of body surface area, and it is administered intramuscularly.9 The dose may be repeated in 1 week if betahCG levels are not decreasing. Before giving methotrexate, a beta-hCG level, complete blood count (CBC), comprehensive metabolic panel (CMP), blood type, and antibody screen should be performed. The beta-hCG should be repeated on day 4. The level is expected to rise before decreasing. On day 7, the beta-hCG, CBC, and CMP are to be repeated. A 15% decline in the beta-hCG level is expected; if not, a second injection may be given with a repeat in protocol.9 If the levels drop appropriately, biweekly beta-hCG levels are done until <100 mIU/mL, and then weekly until <10 mIU/mL. Clinical experience suggests that if there is no decline in beta-hCG levels after 2 doses, surgical intervention must be seriously considered. Surgical Management Surgical management is usually successful with laparoscopy. It is the management of choice if beta-hCG levels are >10,000 mIU/mL or fetal cardiac activity is present. Ideally, the pregnancy is removed (salpingostomy) and the tube is preserved. Under these circumstances, studies suggest that about 50% to 80% of women who have had an ectopic pregnancy are able to have a normal pregnancy in the future.1,11 However, in many cases the fallopian tube cannot be saved and needs to be removed (salpingectomy). Continued on page 18

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The Infertility Nurse

Vitrification of Human Blastocysts: The Way to Go Juergen Liebermann, PhD, HCLD Director of Laboratory, Fertility Centers of Illinois, Chicago, IL

ith approximately 700,000 babies born after cryopreservation, this technology has become a well-established, widely used routine procedure. Based on data from the Centers for Disease Control and Prevention (CDC) from 2003 to 2008, about 20% of all offspring born nationwide from in vitro fertilization (IVF) cycles came from oocyte and embryo cryopreservation. The CDC also compared data of live births per transfer using frozen and fresh embryos (25.9% vs 30.8%), clearly showing that cryopreservation is an important step in maximizing the efficiency of an IVF cycle. Vitrification Technique Traditional embryo cryopreservation can be seen as a very positive contribution to overall patient treatment, but the limitations of current slow-rate freezing methods have become more evident in the clinical arena. One way to achieve an ice-crystalline–free state is to establish a glassy or vitreous state with the use of ultra-high cooling rates provided by vitrification protocols. Vitrification, initially reported as a successful cryopreservation approach for mouse embryos,1 has taken a backseat to the much more widely adopted slowfreezing technology applied to gametes

and embryos in animal and human assisted reproduction. Vitrification protocols are relatively simple for the practitioner, potentially faster, and inexpensive. They rely on the placement of the cell in a very small volume of vitrification medium, which must be cooled at extreme rates not obtainable in regular enclosed cryo-straws or vials. The importance of using a very small volume with the cryotop technology was first described in 2005.2,3

The Advantage of Blastocyst Cryopreservation Activation of the embryonic genome occurs after the 8-cell stage (3 days postoocyte retrieval) is reached.6 If the activation does not occur, the embryo will not survive further. Furthermore, it seems that day 3 morphology can only predict at an approximately 48% rate which embryos will eventually form blastocysts suitable for use on days 5/6.7 Therefore, the improvement of human

As can be seen in our findings, blastocyst-stage freezing is superior to freezing an embryo at an earlier developmental stage, making a successful blastocyst cryopreservation program increasingly relevant. Vitrification protocols are becoming more and more clinically established because of their many advantages, such as more reliability and consistency in cryosurvival compared with traditional slow-freezing protocols. Therefore, vitrification techniques are starting to enter the mainstream of human assisted reproductive technology.4,5

IVF outcomes requires identification of embryos that will progress beyond the 8-cell stage. Blastocyst culture (5 days postoocyte retrieval) allows for the transfer of embryos that clearly have an activated embryonic genome. This requires that the elimination of embryos in extended culture from day 3

to day 5 should depend solely on their inherited survival potential and not be a consequence of an adverse effect exerted by the sequential media used for culture beyond day 3. However, with recent increased confidence in growth stage-sequenced culture media, blastocyst culture for fresh transfers has become more routine. As can be seen in our findings below from the Fertility Centers of Illinois (FCI), Chicago, IL, blastocyst-stage freezing is superior to freezing an embryo at an earlier developmental stage, making a successful blastocyst cryopreservation program increasingly relevant. Therefore, selection is the key to extended culture,8 because the less viable embryos will tend to arrest early in development, “selecting” themselves as noncandidates for fresh transfer or cryopreservation. This may seem like a waste of embryos; nevertheless, the net result is that chances of achieving a pregnancy can be improved. Knowing how to select potentially viable blastocysts is the key to successful outcomes.9 To achieve this goal (1) the assessment of blastocyst quality must accommodate a measure of the 2 chief elements of the embryo at this stage—inner-cell mass (ICM) and trophectoderm (TE)—and Continued on page 21

Blastocyst Cryopreservation by Vitrification Outcomes, January 2004Table 1 July 2010 (N = 3232)

CONTINUING EDUCATION

Day of development Blastocysts vitrified, N (%)

Recognition and Management... Continued from page 17 If rupture has already occurred and there is uncontrolled hemorrhage, a surgical incision into the abdomen (laparotomy) must be performed to regain hemodynamic stability and prevent maternal death. Future fertility is not a priority under these circumstances and may be compromised. Conclusion Despite everyone’s best efforts at times, ectopic pregnancy is sometimes unavoidable. Whenever possible, prevention is the best medicine. Appropriate screening of patients by obtaining a complete history, a physical examination, and assessing the patient’s sexual activity can lead to proper counseling. Patients should be encouraged to limit their number of sexual partners, to always use condoms to prevent sexually transmitted diseases, and to seek early diagnosis and treatment of chlamydia and gonorrhea infections. Appropriate selection of contraception

october 2010 I Vol 2, No 5

is another positive measure in the prevention of ectopic pregnancy. ■ References 1. Sepilian VP, Wood E. Ectopic pregnancy. http:// emedicine.medscape.com/article/258768-overview. Accessed July 15, 2010. 2. Goldner TE, Lawson HW, Xia Z, Atrash HK. Surveillance for ectopic pregnancy—United States, 19701989. MMWR CDC Surveill Summ. 1993;42:73-85. 3. Centers for Disease Control and Prevention. Ectopic pregnancy—United States, 1990-1992. MMWR Morb Mortal Wkly Rep. 1995;44:46-48. 4. Advanced Fertility Center of Chicago. Ectopic pregnancy: tubal pregnancy. www.advancedfertility.com/ ectopic.htm. Accessed July 15, 2010. 5. University of Maryland Medical Center. Ectopic pregnancy. www.umm.edu/pregnancy/000216.htm. Accessed July 15, 2010. 6. Shaw JL, Dey SK, Critchley HO, Horne AW. Current knowledge of the aetiology of human tubal ectopic pregnancy. Hum Reprod Update. 2010;16:432444. Epub 2010 Jan 12. 7. Mayo Clinic staff. Ectopic pregnancy. December 19, 2009. www.mayoclinic.com/health/ectopic-pregnancy/ DS00622/Dsection=symptoms. Accessed July 15, 2010. 8. Lozeau AM, Potter B. Diagnosis and management of ectopic pregnancy. Am Fam Physician. 2005;72:1707-1714. 9. Methotrexate injection prescribing information. Bedford, OH: Ben Venue Laboratories; April 2005. 10. American College of Obstetricians and Gynecologists. Ectopic pregnancy. Patient education pamphlet. ISSN 1074-8601; February 2009. www.acog.org/publications/ patient_education/bp155.cfm. Accessed July 15, 2010. 11. Seeber BE, Barnhart KT. Suspected ectopic pregnancy. Obstet Gynecol. 2006;107:399-413.

Day 5

Day 6

4975 (43) 6106 (54)

Day 7

Total

349 (3)

11,430

NOTE: Average age of patients, 33.7 ± 4.9 years.

Blastocyst Cryopreservation Program Using Vitrification Technology, Table 2 January 2004-July 2010 Parameter

Vitrification technology

Patient’s age, yrs

34.7 ± 5.1

Warmed cycles, N

1995

Transfers, N

1977

Blastocysts warmed, N

3898

Blastocysts survived, N (%)

3767 (96.6)

Blastocysts transferred, N

3725

Mean of blastocysts transferred, N

1.9

Implantations, N (%)

1126 (30.2)

Positive pregnancies from warming, N (%)

975 (48.9)

Positive pregnancies from VET, N (%)

975 (49.3)

Clinical pregnancies from warming, N (%)

857 (43.0)

Clinical pregnancies from VET, N (%)

857 (43.3)

Ongoing pregnancies from VET, N (%)

721 (36.5)

Live births, N

630 (304 boys, 326 girls)

NOTE: Values are numbers unless otherwise described. VET indicates vitrified embryo transfer.

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OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 19

# #

prescribed pr escribed b d progesterone progesterone indicated for AR ART T*

Dissolves. D Delivers. elivers. D Done. one.

ENDOMETRIN® is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an ART treatment program for infertile women. Important Safety Information ENDOMETRIN® should not be used in individuals with any of the following conditions: previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN®, known missed abortion or ectopic pregnancy, liver disease, known or suspected breast cancer, active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. ENDOMETRIN® should be discontinued if any of these are suspected. Patients with a history of depression need to be closely observed when receiving treatment with ENDOMETRIN®. Consider discontinuation if symptoms worsen. ENDOMETRIN® should not be recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert. The most common adverse reactions (greater than 5%) reported in patients receiving ENDOMETRIN® were post-oocyte retrieval pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome.

Please see Brief Summarryy of Prescribing Information on reverse side. *Source: According to data from Wolters Kluwer Pharma Solutions, Source® Pharmaceutical Audit Suite, January 2010 - July 2010, inclusive of reproductive endocrinologist specialty only.

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OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 20

(+=,9:, 9,(*;065:! *SPUPJHS :[\KPLZ ,_WLYPLUJL The safety data reflect exposure to Endometrin in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5.0% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Endometrin was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Endometrin group are listed as follows:

0TWVY[HU[! -VY ]HNPUHS \ZL VUS` -VY M\SS 7YLZJYPIPUN 0UMVYTH[PVU ZLL WHJRHNL PUZLY[ ( IYPLM Z\TTHY` MVSSV^Z 05+0*(;065: (5+ <:(.,! Endometrin is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. *65;9(05+0*(;065:! Endometrin should not be used in individuals with any of the following conditions: â&#x20AC;˘ Previous allergic reactions to progesterone or any of the ingredients of Endometrin â&#x20AC;˘ Known missed abortion or ectopic pregnancy â&#x20AC;˘ Liver disease â&#x20AC;˘ Known or suspected breast cancer â&#x20AC;˘ Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events

,UKVTL[YPU TN [^V [PTLZ KHPS` 5$ Gastrointestinal Disorders: Abdominal pain 50 (12%), Nausea 32 (8%), Abdominal distension 18 (4%), Constipation 9 (2%), Vomiting 13 (3%). General Disorders and Administration Site Reactions: Fatigue 7 (2%). Infections and Infestations: Urinary tract infection 9 (2%). Injury, Poisoning and Procedural Complications: Post-oocyte retrieval pain 115 (28%). Nervous System Disorders: Headache 15 (4%). Reproductive System and Breast Disorders: Ovarian hyperstimulation syndrome 30 (7%), Uterine spasm 15 (4%), Vaginal bleeding 13 (3%).

>(9505.:! *HYKPV]HZJ\SHY VY *LYLIYV]HZJ\SHY +PZVYKLYZ The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. Endometrin should be discontinued if any of these are suspected.

,UKVTL[YPU TN [OYLL [PTLZ KHPS` 5$ Gastrointestinal Disorders: Abdominal pain 50 (12%), Nausea 29 (7%), Abdominal distension 17 (4%), Constipation 14 (3%), Vomiting 9 (2%). General Disorders and Administration Site Reactions: Fatigue 12 (3%). Infections and Infestations: Urinary tract infection 4 (1%). Injury, Poisoning and Procedural Complications: Post-oocyte retrieval pain 102 (25%). Nervous System Disorders: Headache 13 (3%). Reproductive System and Breast Disorders: Ovarian hyperstimulation syndrome 27 (7%), Uterine spasm 11 (3%), Vaginal bleeding 13 (3%).

+LWYLZZPVU Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.

,_WLJ[LK (K]LYZL 9LHJ[PVU 7YVĂ&#x201E;SL :LLU ^P[O 7YVNLZ[LYVUL Endometrin is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.

<ZL VM 6[OLY =HNPUHS 7YVK\J[Z Endometrin not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert.

6=,9+6:(.,! Treatment of overdosage consists of discontinuation of Endometrin together with institution of appropriate symptomatic and supportive care.

79,*(<;065:! 7YLNUHUJ`! Endometrin has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The livebirth outcomes of these pregnancies were as follows: Among the 404 subjects treated with Endometrin twice daily, 143 subjects had livebirths consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203 livebirths). Among the 404 subjects treated with Endometrin three times daily, 155 subjects had livebirths consisting of 91 singletons, 60 twins, and 4 triplets. In this treatment group, 22 subjects had a spontaneous abortion, 4 subjects had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.1% based on 223 livebirths). Birth defects reported in the Endometrin twice daily group included: one fetus with a cleft palate and intrauterine growth retardation, one fetus with spina bifida, three fetuses with congenital heart defects, one fetus with an umbilical hernia, and one fetus with an intestinal anomaly. Birth defects reported in the Endometrin three times daily group included: one fetus with an esophageal fistula, one fetus with hypospadias and an underdeveloped right ear, one fetus with Downâ&#x20AC;&#x2122;s and an atrial septal defect, one fetus with congenital heart anomalies, one fetus with DiGeorgeâ&#x20AC;&#x2122;s syndrome, one fetus with a hand deformity, and one fetus with cleft palate. 5\YZPUN 4V[OLYZ! Detectable amounts of progesterone have been identified in the milk of nursing mothers. The effect of this on the nursing infant has not been determined. 7LKPH[YPJ <ZL! This drug is not intended for pediatric use and no clinical data have been collected in children. .LYPH[YPJ <ZL! No clinical data have been collected in patients over age 65.

ÂŠ2010 Ferring Pharmaceuticals Inc.

9/10

*(9*056.,5,:0: 4<;(.,5,:0: 047(094,5; 6- -,9;030;@! Nonclinical toxicity studies to determine the potential of Endometrin to cause carcinogenicity or mutagenicity have not been performed. The effect of Endometrin on fertility has not been evaluated in animals. /6> :<7730,+ :;69(., (5+ /(5+305.! Each Endometrin Vaginal Insert is a white to off-white oblong-shaped insert debossed with â&#x20AC;&#x153;FPIâ&#x20AC;? on one side and â&#x20AC;&#x153;100â&#x20AC;? on the other side. Each EndometrinÂŽ (progesterone) Vaginal Insert, 100 mg, is packed individually in a sealed foil pouch. These pouches are available in cartons packed: 21 vaginal inserts with 21 disposable vaginal applicators (NDC 55566-6500-3) Store at 25Â°C (77Â°F); excursions permitted to 15-30Â°C (59-86Â°F). 9_ VUS` Manufactured by: Pharmaceutics International Inc., Hunt Valley, MD 21031 Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 6323-01

For more information, go to www.endometrin.com.

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OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 21

The Infertility Nurse

Vitrification of Human Blastocysts... (2) the use of a convenient cryopreservation protocol; before cryopreservation is considered, the ICM/TE cell count and integrity need to be sufficient to indicate potential embryonic viability. Successful vitrification of rhesus monkey blastocysts with the cryoloop has resulted in a high (85%) survival rate.9 Vitrification of human blastocysts using different carriers shows survival rates of more than 90%, with clinical pregnancy rates of more than 40% and implantation rates higher than 30%.10-12 Natural and hormone replacement cycles seem to provide comparable levels of receptivity in naturally cycling women, although they differ in levels of convenience. The easiest way to calculate the day of transfer is to calculate the “day of ovulation” (whether in a natural or artificial transfer cycle), and then thaw and transfer all blastocysts on the fifth day of development, counting “ovulation” day as day zero. Regardless of the day (5, 6, or 7) embryo cryo preservation occurs at thawing, blastocysts should be treated as if they had been frozen on day 5 of development. Vitrification at IVF Laboratory River North Between January 2004 and July 2010, FCI IVF Laboratory River North, Chicago, IL, has vitrified 11,430 blastocysts without artificial shrinkage before the cryopreservation procedure (Table 1, page 18). After 1977 vitrified embryo transfers (VETs), including day 5 and 6 blastocysts (mean patient age, 34.7 ± 5.1 years), we have seen a 96.6% survival rate, a 30.2% implantation rate, and a 43.3% clinical pregnancy rate (cPR; Table 2, page 18). In addition, in 662 VETs, using aseptic vitrification, 1233

blastocysts were transferred, resulting in a 97.6% survival rate, a 32.1% implantation rate, and a 45.8% cPR (Table 3). After >6 years of vitrifying blastocysts, we have seen 506 deliveries with vitrified blastocysts, totaling 630 babies born (304 boys, 326 girls; Table 2). No abnormalities were recorded. Table 4 lists the data in which the vitrified-warmed blastocysts were divided into day 5 and day 6 groups. In 968 VETs transferring day 5 blastocysts, the survival rate, implantation rate, and cPR were 96.5%, 34.4%, and 48.9%, respectively, compared with 96.7%, 26.1%, and 38.1%, respectively, for day 6 blastocysts. As shown in Table 4, implantation and cPR rates in the day 5 blastocyst group were significantly higher than those in day 6. Comparing day 5 and day 6 outcomes using a closed system, the rates for survival, implantation, and cPR were 97.9%, 36.6%, and 50.6% versus 97.4%, 26.7%, and 41.1%, respectively (Table 5). As shown in Table 5, implantation and cPR occurring in the day 5 blastocyst group were significantly higher than transferring day 6 blastocysts.

Continued from page 18

D. On average, fewer embryos per patient are cryostored, but each one has a greater potential for implantation when thawed. However, the true value of vitrification at the blastocyst stage lies in the opportunity for an embryo transfer with a single blastocyst. That will increase the implantation rate and decrease the incidence of high-order multiple pregnancies. Furthermore, a vitrification solution with a mixture of 7.5% EG/DMSO, followed by a 15% EG/DMSO with 0.5 M sucrose step, is safe for clinical use and results in healthy babies without abnormalities. Vitrification of blastocysts using an open or closed system (Cryotop or HSV) is effective for achieving high

implantation and pregnancy rates, as seen in fresh embryo transfers. Although the outcomes in implantation and clinical pregnancy are significantly different when comparing day 5 blastocysts with day 6 blastocysts, our data should encourage cryopreservation of day 6 blastocysts as well. Based on our data, it is clear that the vitrification of day 6 blastocysts is of clinical value, because it can result in live births. This observation is confirmed by others,13,14 who found that blastocyst development rate impacts outcome in slow cryopreserved blastocyst transfer cycles. Although some problems remain to be fully addressed with vitrification as a routine cryopreservation technique, Continued on page 22

Comparing Cryopreservation Program Outcomes of Vitrified Blastocysts Table 4 on Day 5 and Day 6, January 2004-July 2010 Day of development

Day 5

Day 6

34.6 ± 5.3

34.8 ± 4.9

971

1024

Transfers, N

968

1009

Blastocysts warmed, N

1955

1943

1887 (96.5)

1880 (96.7)

1863

1862

Patient’s age, yrs Warmed cycles, N

Blastocysts survived, N (%)

Practical Implications Our data have shown that freezing at the blastocyst stage provides excellent survival, implantation, and clinical pregnancy. To achieve these outcomes, consider these points: A. Without a successful blastocyst vitrification storage program, extended culture should never be attempted B. The blastocyst is composed of more cells and is therefore better able to compensate for cryoinjury C. The cells are smaller, which makes cryoprotectant penetration faster

Blastocysts transferred, N Mean of blastocysts transferred, N

1.9

1.8 a

486 (26.1)a

Positive pregnancies from warmed cycles, N (%)

543 (55.9)

432 (42.2)b

Positive pregnancies from VET, N (%)

543 (56.1)b

432 (42.8)b

Clinical pregnancies from warmed cycles, N (%)

473 (48.7)b

384 (37.5)b

Clinical pregnancies from VET, N (%)

473 (48.9)b

384 (38.1)b

398 (41.1)

323 (32.0)b

367

263

Implantations, N (%)

640 (34.4)

Ongoing/delivered pregnancies from VET, N (%) Live births, N a Values bValues

within a row with the same superscript are significantly different, P <.05. within a row with the same superscript are significantly different, P <.01. VET indicates vitrified embryo transfer.

Table 3 Blastocyst Cryopreservation Program Outcomes Using Aseptic Vitrification Technology, June 2007-July 2010

Table 5 Comparing Cryopreservation Program Outcomes of Aseptic Vitrified Blastocysts on Day 5 and Day 6, January 2004-July 2010

Parameter

Day of development

Patient’s age, yrs

Aseptic vitrification technique 34.6 ± 5.2

Patient’s age, yrs

Day 5

Day 6

34.5 ± 5.6

34.7 ± 4.8

Warmed cycles, N

666

Warmed cycles, N

324

342

Transfers, N

662

Transfers, N

324

338

1275

Blastocysts warmed, N

627

648

614 (97.9)

631 (97.4)

Blastocysts transferred, N

609

648

Mean of blastocysts transferred, N

1.9

Blastocysts warmed, N Blastocysts survived, N (%) Blastocysts transferred, N Mean of blastocysts transferred, N Implantations, N (%)

1245 (97.6) 1233 1.9 396 (32.1)

Positive pregnancies from warmed cycles, N (%)

342 (51.4)

Positive pregnancies from VET, N (%)

342 (51.7)

Clinical pregnancies from warmed cycles, N (%)

303 (45.5)

Clinical pregnancies from VET, N (%)

303 (45.8)

Ongoing pregnancies from VET, N (%)

253 (38.2)

Live births, N NOTE: Values are numbers unless otherwise described. VET indicates vitrified embryo transfer.

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156 (78 boys, 78 girls)

Blastocysts survived, N (%)

1.8

223 (36.6)

173 (26.7)a

Positive pregnancies from warmed cycles, N (%)

186 (57.4)

173 (45.6)a

Positive pregnancies/VET, N (%)

186 (57.4)a

156 (46.2)a

Clinical pregnancies from warmed cycles, N (%)

164 (50.6)a

139 (40.6)a

Clinical pregnancies/VET, N (%)

164 (50.6)a

139 (41.1)a

115 (34.0)a

Implantations, N (%)

Ongoing/delivered pregnancies from V ET, N (%) Live births, N

138 (42.6) 99

NOTE: Values are numbers unless otherwise described. a Values within a row with the same superscript are significantly different, P <.05. VET indicates vitrified embryo transfer.

october 2010 I Vol 2, No 5

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The Infertility Nurse

Vitrification of Human Blastocysts... vitrification is showing much promise as a viable alternative to conventional freezing technology. Trying to convince embryologists to convert from the slowfreeze protocols with which they are familiar is perhaps one of the greatest hurdles that remains in the acceptance and use of vitrification. Nevertheless, when IVF programs finally overcome

Vitrification of human blastocysts is a viable and feasible alternative to traditional slow-freezing methods.

optimal timing of embryo cryopreservation (eg, individual blastocysts may be cryopreserved at their optimal stage of development and expansion). In addition, the often discussed topic of using open systems (direct contact between cells and LN2) and the possible danger of contamination by bacteria, fungus, or different strains of virus from LN2, can be avoided by moving forward to a closed system providing lower cooling rates, but without a negative impact on the outcome. ■ Acknowledgments

this fear of the unknown and take on the challenge of a short learning curve with vitrification, then vitrification protocols will become more and more clinically established. Conclusion Vitrification of human blastocysts is a viable and feasible alternative to traditional slow-freezing methods. The key to this success lies in the more

The author thanks Angelina Beltsos, MD, Christopher Sipe, MD, Meike Uhler, MD, Kevin Lederer, MD, Aaron Lifchez, MD, Jane Nani, MD, Eve Feinberg, MD, Laurence Jacobs, MD, and John Rapisarda, MD, at FCI; and Elissa Pelts, BS, Jill Matthews, BS, Sara Sanchez, BS, Yuri Wagner, BS, Rebecca Brohammer, BS, and Ewelina Pawlowska, MS, at FCI IVF Laboratory River North, for their invaluable contributions and support in pushing vitrification to become the standard protocol for cryopreservation of human blastocysts within our program.

References 1. Rall WF, Fahy GM. Ice-free cryopreservation of mouse embryos at –196 degrees C by vitrification. Nature. 1985;313:573-575. 2. Kuwayama M, Vajta G, Kato O, Leibo SP. Highly efficient vitrification method for cryopreservation of human oocytes. Reprod Biomed Online. 2005;11:300-308.

Amniotic Fluid Banking...

Photo courtesy of Biocell Center.

unlike more developed adult stem cells, have the potential to develop into different cells and tissue types. Stem cells present in the amniotic fluid are pluripotent; namely, they have the ability to develop into different tissues (eg, cartilage, bone, and hematopoietic and adipose tissue), and may have curative and regenerative potential. The range of applications is broadening, with investigations into tissue regeneration, diabetes, and neurodegenerative disorders. With more than 130 ongoing human trials (according to www.clinicaltrials. gov, as of July 2010), pluripotent, mesenchymal stem cells are the next wave in the growing field of cell therapy.

Cryopreservation of amniotic fluid stem cells.

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Continued from page 21

3. Kuwayama M. Highly efficient vitrification for cryopreservation of human oocytes and embryos: the Cryotop method. Theriogenology. 2007;67:73-80. Epub 2006 Oct 20. 4. Liebermann J, Nawroth F, Isachenko V, et al. Potential importance of vitrification in reproductive medicine. Biol Reprod. 2002;67:1671-1680. 5. Liebermann J, Dietl J, Vanderzwalmen P, Tucker MJ. Recent developments in human oocyte, embryo and blastocyst vitrification: where are we now? Reprod Biomed Online. 2003;7:623-633. 6. Braude P, Bolton V, Moore S. Human gene expression first occurs between the four- and eight-cell stages of preimplantation development. Nature. 1988;332:459-461. 7. Graham J, Han T, Porter R, et al. Day 3 morphology is a poor predictor of blastocyst quality in extended culture. Fertil Steril. 2000;74:495-497. 8. Tucker MJ, Liebermann J. Morphological scoring of human embryos and its relevance to blastocyst transfer. In: Patrizio P, Tucker MJ, Guelman V, eds. A Color Atlas for Human Assisted Reproduction: Laboratory and Clinical Insights. Philadelphia, PA: Lippincott Williams & Wilkins; 2003:99-108. 9. Yeoman RR, Gerami-Naini B, Mitalipov S, et al. Cryoloop vitrification yields superior survival of Rhesus monkey blastocysts. Hum Reprod. 2001;16:1965-1969. 10. Liebermann J, Tucker MJ. Comparison of vitrification and conventional cryopreservation of day 5 and day 6 blastocysts during clinical application. Fertil Steril. 2006;86:20-26. Epub 2006 Jun 8. 11. Liebermann J. Vitrification of human blastocysts: an update. Reprod Biomed Online. 2009;19(suppl 4):4328. 12. Stachecki JJ, Garrisi J, Sabino S, et al. A new safe, simple and successful vitrification method for bovine and human blastocysts. Reprod Biomed Online. 2008; 17:360-367. 13. Shapiro BS, Richter KS, Harris DC, Daneshmand ST. A comparison of day 5 and 6 blastocyst transfers. Fertil Steril. 2001;75:1126-1130. 14. Levens ED, Whitcomb BW, Henessy S, et al. Blastocyst development rate impacts outcome in cryopreserved blastocyst transfer cycles. Fertil Steril. 2008;90: 2138-2143.

IVF Pioneer Winner of Nobel Prize in 2010 The field of infertility has reached a new peak recently, when the Nobel committee awarded Robert Edwards the Nobel prize in physiology/medicine. In the October 4, 2010, Bulletin of the American Society for Reproductive Medicine (ASRM), William Gibbons, MD, ASRM President, said, “The development of In Vitro Fertilization truly revolutionized infertility care, allowing millions of patients to become parents. It also allowed us to further develop our understanding of human reproduction and development, leading further advances. professor Edwards and Doctor Steptoe tackled not only formidable scientific obstacles in order to make this advance, but worked in the face of significant social opposition as well. We are pleased the Nobel committee has chosen to recognize this very important work” (www.asrm.org/news/ article.aspx?id=4516). ■

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are fully compatible with their own bodies. In addition to autologous use, this “biological insurance” may extend to other members of the same family with a high probability of a match. By preserving a child’s amniotic fluid cells, parents ensure that their child may be the beneficiary of the discoveries of stem-cell research. Michael Jingco, RN, NP

Developing medical therapies with these cells are focused on skin and connective tissue, as well as organ structures, including tracheas, diaphragms, and heart valves. For example, British scientists have shown that mesenchymal stem cells can potentially treat and alleviate the pain of arthritis. In their current trial involving 70 patients with diagnosed knee osteoarthritis, these researchers are investigating whether cartilage regeneration with stem cells will produce sufficient amounts of robust new cartilage and healthier knees for patients with knee osteoarthritis. Previous studies have demonstrated that amniotic fluid stem cells show strong potential for cardiac regenerative therapy.1,2 The greatest advantage of preserving amniotic fluid cells is that newborns will always have a sample of cells that

ACOG Guidelines on Amniocentesis In its Screening for Fetal Chromosomal Abnormalities guideline, the American Congress of Obstetricians and Gynecologists (ACOG) recommended that the choice of screening and invasive diagnostic testing for aneuploidy, such as amniocentesis and chorionic villus sampling, should be offered to all women who present for prenatal care before 20 weeks of gestation, regardless of maternal age.3 This guideline relied on the much lower than previously assumed 1:200 to 1:400 risk for miscarriage or infection conferred by the amniocentesis procedure, as supported by the First And Second Trimester Evaluation of Risk (FASTER) study, which enrolled 35,003 patients and was sponsored by the National Institutes of Health. The results showed that the procedurerelated fetal loss rate after midtrimester amniocentesis was 0.06% (or 1 in 1600), and that there was no signifi-

cant difference in loss rates between women undergoing and those not undergoing amniocentesis.4 Collecting Amniotic Fluid during Pregnancy Preservation of amniotic fluid stem cells is offered exclusively to pregnant women who, after consulting their doctor, choose to perform amniocentesis for diagnostic reasons. There are no changes to the standard amniocentesis procedure when obtaining the sample of amniotic fluid with stem cells. During the procedure, small amounts of the fluid are set aside and transferred to the amniotic fluid stem-cell laboratory for preservation. After the sample is processed, it is stored in a cryobank that is equipped with advanced temperature controlling and monitoring technology. An estimated 400,000 women in the United States undergo amniocentesis annually. ■ References 1. Yeh YC, Wei HJ, Lee WY, et al. Cellular cardiomyoplasty with human amniotic fluid stem cells: in vitro and in vivo studies. Tissue Eng Part A. 2010;16:1925-1936. 2. Schmidt D, Achermann J, Odermatt B, et al. Cryopreserved amniotic fluid-derived cells: a life-long autologous fetal stem cell source for heart valve tissue engineering. J Heart Valve Dis. 2008;17:446-455. 3. ACOG Committee on Practice Bulletins. ACOG Practice Bulletin No. 77: screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007;109:217-227. 4. Eddleman KA, Malone FD, Sullivan L, et al. Pregnancy loss rates after midtrimester amniocentesis. Obstet Gynecol. 2006;108:1067-1072.

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Clinical News Continued from page 5

greater weight gain were shown to have more than a 2-fold risk of delivering an infant weighing >4000 g (8.8 lb).

Bariatric Surgery Alleviates Gestational Diabetes, Cesarean Risk Among the myriad health hazards of obesity is the increased risk for gestational diabetes. Bariatric surgery helps to reduce this risk according to the results of a new study (Burke AE, et al. J Am Coll Surg. 2010;211:169-175. Epub 2010 Jun 8). Using an insurance claims database comprised of 23,594 women who underwent bariatric surgery, researchers identified 346 women who delivered a child before bariatric surgery and 354 women who delivered after bariatric surgery. Women who delivered after bariatric surgery had an 8% rate of gestational diabetes compared with 27% when surgery was done after delivery; similarly, surgery before delivery resulted in a 15% lower rate (28% vs 43%) of cesarean section than surgery after delivery.

risk increased with increasing dosage of radiation. No increased risk was found in women who received only pituitary irradiation or in men with testicular irradiation.

Low-Dose Estrogen Patch Avoids Stroke Risk from HRT Previous studies have shown an increased risk for stroke in postmenopausal women using oral hormone replacement therapy (HRT), but a new

study indicates that using low-dose transdermal estrogen therapy can avoid this risk (Renoux C, et al. BMJ. 2010; 340:c2519). Data were collected from a UK database of 400 general practices between 1987 and 2006. This nested case-control study included postmenopausal women (aged 50-79 years) who did not have stroke at the start of the study. The researchers matched each stroke case among the 15,710 stroke cases that occurred during the

study with up to 4 of the controls (N = 59,958). Users of HRT were randomized according to low- and high-dose oral or patch administration of HRT. The use of low- and high-dose oral HRT was associated with a 25% to 30% increased risk for stroke, but use of a low-dose (≤50 µg) estrogen patch did not increase stroke risk. However, the use of a high-dose (>50 µg) patch was associated with an increased stroke risk compared with no use. ■

CONTINUING EDUCATION CREDITS

Nonbreastfeeding Increases Risk for Diabetes Delivering a baby increases the risk for type 2 diabetes, but mothers who breastfeed for ≥1 month decrease their likelihood of developing the disease, new data show (Schwarz EB, et al. Am J Med. 2010;123:863.e1-863.e6). Among the 2233 women (aged 40-78 years) enrolled in the Reproductive Risk Factors for Incontinence Study at Kaiser (2003-2008), 1828 were mothers. In mothers who breastfed for ≥1 month, the risk for diabetes was on par with that of nulliparous women. Mothers who never breastfed had an increased risk for developing diabetes versus those who breastfed for 1 to 3 months only. These findings were independent of physical activity levels and body mass index later in life.

Current activities at www.COEXM.com include:

Pelvic Radiation before Puberty a Risk for Stillbirth, Neonatal Death Undergoing radiation therapy to the pelvic area in childhood is linked to delivering a stillborn and to neonatal death, most likely because of permanent uterine damage, according to researchers from the International Epidemiology Institute of the National Cancer Institute (Signorello LB, et al. Lancet. 2010; 376:624-630. Epub 2010 Jul 23). The outcomes of 4946 pregnancies among 1148 men and 1657 women who survived childhood cancer were examined. The risks of stillbirth and neonatal death among mothers who had radiation to the uterus and ovaries before menarche were up to 12-fold greater when receiving total doses of 2.5 Gy or higher compared with the survivors not exposed to radiation in these areas. The

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The Urology Nurse

Androgenic-Anabolic Steroid Abuse and Male Infertility Ellen Tougias, RN, BSN IVF Program Coordinator, Baystate Reproductive Medicine, Springfield, MA

he abuse of androgenic-anabolic steroids, better known as performance-enhancing drugs, has become a familiar topic. Reports of anabolic steroid abuse have challenged the careers of many outstanding athletes. However, this problem is not confined to the elite athlete. College, highschool, and even middle-school athletes, as well as recreational athletes, are using these drugs. The number of nonathlete abusers is increasing, as some men try to improve their bodies and appearance by using steroids.

Steroids: The Good and the Ugly Serious health issues can result from the nonmedical use of steroids. Some effects are reversible, but many can be life-threatening. Male infertility can result from steroid abuse, which may be the first time the abuser is faced with one of the negative effects of these drugs and seeks medical care. Considering the possibility of steroid abuse with a couple diagnosed with male factor infertility may not only help treat infertility but also prevent serious health issues in these men. Androgenic-anabolic steroids are a

group of synthetic derivatives of testosterone, a drug that is not usually taken alone, because it is metabolized very quickly in the body, rendering its effects insignificant. The chemical derivatives of testosterone have been designed to prolong the effects of testosterone and increase its effectiveness. These products can be administered orally, transdermally, or by injection. The androgenic action of these drugs causes increased strength, power, and muscle mass, as well as other typical male characteristics, such as a deeper voice and male pattern hair growth. The anabolic action induces a build-up effect by stimulating protein synthesis and inhibiting its breakdown. Some substances have greater androgenic effects, and others have greater anabolic effects. Some men believe that these drugs also induce a euphoric state, often referred to as “a steroid rush,” which decreases fatigue and provides greater endurance for training, although this has not been substantiated.1 Abusers usually use a specific regimen when taking steroids. Some men “stack” or “pyramid” them, meaning they combine 2 or more drugs while increasing

the doses in short periods. Other men “cycle” the drugs, meaning they use the drugs intermittently; such a break from drug use prevents a perceived desensitization to its effects.1 These drugs are obtained through underground publications, online, bodybuilder magazines, athletic trainers, and other abusers. Therefore, information about the longterm effects of abuse is often not revealed or is ignored, and many are unaware of their side effects. Steroids and Infertility To understand the effects of steroids on male fertility, it is easiest to begin with the hypothalamus-pituitary-testis axis, which works through a negative feedback system. The hypothalamus secretes gonadotropin-releasing hormone (GnRH), which stimulates the anterior pituitary to release folliclestimulating hormone (FSH) and luteinizing hormone (LH). FSH causes the Sertoli cells to supply immature sperm cells with nutrition and releases androgen-binding hormones and inhibin. LH is responsible for stimulating the Leydig cells, located in the interstitial fluid of the testes, to convert cholesterol to testosterone. Testosterone is then

Active Surveillance Recommended for Small, Incidental Testicular Masses By Jill Stein

esearchers are proposing active surveillance of small, testicular masses detected incidentally during an infertility evaluation in lieu of conventional surgical treatment. New study results presented by a Canadian group at the American Urological Association 2010 annual meeting indicate that most small, incidental nonpalpable testicular masses can be safely followed with serial ultrasound and do not show significant growth requiring surgery. Such lesions have been traditionally treated with surgical excision because of concern for potential malignancy. Paul J. Toren, MD, urology resident at the University of Toronto, Ontario, and colleagues reviewed their experience using a conservative ultrasound surveillance strategy between 2001 and 2008 at the Mount Sinai Hospital Fertility Clinic, Toronto. “With the widespread use of scrotal ultrasound in the evaluation of male infertility, the incidental detection of small testicular masses is increasing,” Dr Toren explained.

The management of these lesions, however, is controversial, he said. First, ultrasound alone cannot accurately determine whether a lesion <1 cm is benign or malignant. Second, testicular cancer is thought to be more prevalent in infertile men. Treatment has usually involved orchiectomy because of concern about malignancy, Dr Toren said.

“With the widespread use of scrotal ultrasound in the evaluation of male infertility, the incidental detection of small testicular masses is increasing.” —Paul J. Toren, MD

For the past several years, the Mount Sinai Hospital Fertility Clinic has been offering ultrasound surveillance to men in whom nonpalpable testicular masses <1 cm are detected incidentally during an evaluation for

TAKEAWAY QUICK POINTS ➤ Infertility evaluation is often the reason for finding small (<1 cm in diameter), nonpalpable testicular lesions. ➤ Clinicians should tell patients that such lesions are not associated with testicular cancer. ➤ Ultrasound surveillance is now recommended instead of surgical excision, unless the lesion size has been increasing. infertility. Dr Toren presented results in 46 such men who had ≥1 hypo echoic, nonpalpable intratesticular masses <1 cm in diameter. Infertility was the reason for referral in 39 men. On serum analysis, 16 men showed evidence of azoospermia, 16 men had oligospermia, and 7 had normospermia. Semen analysis was not available in 6 men. During the ultrasound surveillance period (mean, 253 days), patients were examined by a urologist before or after each ultrasound to confirm the absence of palpable lesions. Continued on page 26

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picked up by androgen-binding hormones and brought to the waiting sperm cells to induce maturation. Although the negative feedback system is not completely understood, FSH production is regulated by inhibin, and LH production is regulated by testosterone.2 The abuse of steroids affects fertility because of this negative feedback system. Steroid use inhibits GnRH production from the hypothalamus. Gonadotropins are not released, and the production of testosterone in the testes does not occur, which changes the quality of the sperm and causes oligospermia, or even azoospermia, within a few months. The testes atrophy, and although initially the sex drive is enhanced, it can often diminish over time. Many abusers try to counteract testicular atrophy by adding exogenous testosterone, human chorionic gonadotropin (hCG), or clomiphene to their regimen. By acting like LH in the body, hCG stimulates Leydig cell production of testosterone. This may help to increase sperm concentration, but quality is probably still affected.3 Much of the fertility-related damage, however, can be reversed once the abuser stops. The amount of time to complete return of reproductive function depends on the drugs used, and the doses and the length of time they were used, but it can take a minimum of 4 to 6 months. Rarely, hypogonadotropic hypogonadism is complete and nonreversible. Advising Your Patients Men presenting with male factor infertility and a suspicion of steroid use must be counseled about the dangers of these drugs, not just relative to their fertility but also to their overall long-term health. Like most drug abusers, the majority will not admit to steroid use, but they may hear information that will help them stop using steroids or even seek help. Partners may also be hearing this information for the first time and can be a helpful ally in treatment. Men abusing steroids should be referred to a urologist for further evaluation regarding infertility and urged to confide in their primary care physician for longterm health monitoring. As noted earlier, in the majority of cases the effects on infertility are reversible and success with treatment is a reachable goal. ■ References 1. Basaria S. Androgen abuse in athletes: detection and consequences. J Clin Endocrinol Metab. 2010;95:15331543. Epub 2010 Feb 5. 2. Griffin JE, Wilson JD. Male reproductive physiology. Up to Date. www.uptodate.com/patients/content/topic. do?topicKey=~Q/QCtwVSFdcVN2. Accessed September 15, 2010. 3. Hartgens F, Kuipers H. Effects of androgenic-anabolic steroids in athletes. Sports Med. 2004;34:513-554.

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Join the Academy at

www.obgyn-infertility-nurse.org First-year membership $39.95 includes more than $200 off future Annual Meeting registration for Full Members. Membership is open to all OB/GYN, Infertility, and Urology Nursing Professionals. As a member you will receive resources on patient care best practices, continuing education, and opportunities to interact with your peers.

APRIL 2010 WWW.OBGY N-INFERTILIT Y-NURSE.CO M VOL 2, NO 2

Member Benefits Include: to The OB/GYN Nurse, . Written for nurses by nurses,it covers current and pertinent information on the physiologic, medical, and psychological aspects of human reproduction, with special emphasis on the nurse’s role in patient care ($150 value).

CLINIC PRO FILE

Fertility Preser Focus of Ferti vation the lity Institute

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on all American Academy of OB/GYN Nurses™ educational activities, including more than $200 off future Annual Meeting registration fees.

EMERGING QUESTIONS

Interview with Kutluk Oktay, MD, FACOG Professor of Obste trics & Gynec Director, Divisio ology, Medic & Gynecology n of Reproductive Medicine ine, and Cell Biology & Anato ; Medical Direct & my; Medical Colleg or, Institute for Infertility, Department of Obste e, Valhalla, NY Fertility Prese trics rvation, New York

Will HPV Scree the Pap Smea ning Replace r?

Experts Debate the

By Caroline Helwi ck

ccording to the Amer lege of Obstetrician ican Col- ing a major shift from the curren t annucologists (ACO s and Gyne- al screening. The new guidelines G), the use of cytologic testin include: • Raising first g (ie, Pap smear screening to reduced the incide ) has age 21, avoiding screen nce of cervical ing earlier by >50% in the cancer • For patien past 30 years. ts aged 21 to 29 years, ertheless, in its Nev screening every new practice guidel 2 years only (Obstet Gynec ines • Optio ol. 2009;114:1 nal screening every 409-1420) released on Novem 3 years for patients has made major ber 20, 2009, ACOG • Optio aged 30 to 65 years nal stopping changes to cervic cytology screen al 65 and 70 years, screening between ing guidelines, in patients with representprevious negat 3 ive tests.

CLINIC SPO TLIGHT

Center: Kutluk Xintao Wang, Oktay, MD, FACOG. Left to right: Sangh PhD; Gina Triggs, Elke Heytens, oon Lee, MD; PhD; Rishi Anad, Office Assistant; Angela Sinan Ozkavu kcu, Downey, RN; MD. Reza Soleimani, MD; MD;

r Kutluk Oktay , an internationally renowned What are the expert in fertilit main features y your Instit of preservation skills in the areas , combines unique Preservatioute for Fertility of OB/GYN, infert n? ity, and fertili ilOur center is uniqu ty preservatio e in that it brings n. asked him to describe the featur We together key exper tise in fertili his clinic and es of preservation ty the fertility preservationrole nurses play in and other for patients with cancer chronic diseas . es. Altho the majority of our patients currenugh tly

Safety of VTE Pregnant Wo Prophylaxis in men Varies

Continued on page

By Wayne Kuzna r

or pregnant wome n with a history of venous vious idiopathic throm (VTE), antepartum boembolism of antepartum thrombosis, a strategy proph VTE prophylaxis can be cular-weight hepar ylactic low-molesafely avoided in if woman had a previous secon the postpartum prophylacti(LMWH) and thrombosis. If, however, she had dary warfarin is effective c LMWH or a pre- Mich and safe, said ael Kovacs, MD, Professor of Continued on page

The Offic Offical ialPubli Publicatio cationnofof

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for issues such as coverage and reimbursement.

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The Good, th Ambiguous e Bad, and the Disc ussing Test Res ults

with Patients

Kriston Ward, MS, RN, NP-C , and Germaine Strong Fertility Santoriello, RN, Center, Unive BSN rsity of Rochester, Rochester, NY

urses working in the field of infertility can attest to the rewards and challe nges of sharing pregnancy test results patients. Noth ing is better than with able to make that being the news—“you’r phone call to deliver e trast, sharing test pregnant.” In conthe most difficu results can be one of lt tasks for the infertility nurse. Test results are not easy to discus alway s s with they are not alway patients, because From left: Kriston Ward, Germa s the outcome ine Santoriello. patient desires. the process is the variability Often, compoundi eviden ng the difficulties interpretation of quantitativ t in the associated with e serum human chorio this communica tion levels (also nic gonadotropin (QhCG) known as beta hCG) of any Continued on page

Inside

Continuing Educ Reproductive Depre ation ssions

Page 10

Nurse Perspective: Postpartum Depression

Page 12

• Obtain to the enhanced, member-only sections at www.obgyn-infertility-nurse.org to network with your peers in a community of OB/GYN, Infertility, and Urology Nursing Professionals. Discuss current and emerging diagnostic and therapeutic options, as well as strategies for counseling and follow-up of patients.

Pros and Con s

OB/GYN Nurs First Term Stillbo e Caused by Oral rn Bacteria Page 14

Pharmacy Corn Infertility Medicationer Storage

Page 19

Legal Matters For Clinicians Deali ng with Gestational Carri ers

Page 20

Nutrition Vitamin D Defici Depression, Insuli ency Linked to n Resistance

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The official pu blication of the American Academy of OB/GYN N urses

OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 26

Nutrition

Eating Healthy Food Does Not Have to Cost More By Rosemary Frei, MSc

eople who dig deeper into their wallets to pay for food are not necessarily eating better. Analysis of responses to the 2002 Nurses’ Health Study (NHS) showed that some of the women who spent the most daily on home-prepared food had a relatively low score on an index of food healthfulness (Bernstein AM, et al. Relation of food cost to healthfulness of diet among

TAKEAWAY QUICK POINTS ➤ In the Nurses’ Health Study, those spending less on food had higher scores on the healthy eating index than those spending more. ➤ They also had higher intakes of foods such as fruit, vegetables, poultry, fish, nuts, soy, beans, and whole grains, and lower intakes of red and processed meat, high-fat dairy, and snacks and sweets. ➤ These nurses also had lower rates of angina, diabetes, and hypertension.

“For any cost, the healthfulness of a diet can range from excellent to horrible. Partially replacing red meat with nuts is the best health bargain, as it increases health and reduces cost.” —Walter Willett, PhD US women. Am J Clin Nutr. 2010 Sep 1. Epub ahead of print). The health of subjects’ eating patterns was measured by the Alternative Healthy Eating Index (AHEI); scores can range from 2.5, representing the least healthful pattern, to 87.5 for the best eating pattern. The AHEI is a measure of intake of foods and nutrients such as fruit, nuts, soy, and cereal fiber that have previously been shown to be associated with a lower risk for chronic disease. AHEI scores among nurses who ate the most healthfully ranged from 52 for those who spent $3.48/day to 67 for those who spent $5.75/day. Among the nurses who ate the least healthfully, the scores ranged from 27 to 38.5, respectively, at those spending levels.

“Our study makes the important point that, while there is some correlation between what people spend on food and the healthfulness of their diet, for any cost, the healthfulness of a diet can range from excellent to horrible. “This destroys the myth that someone must spend a lot to eat a healthy diet,” lead investigator Walter Willett, PhD, Chair, Department of Nutrition, and Fredrick John Stare Professor of Epidemiology and Nutrition, Harvard School of Public Health, Boston, told the OB/GYN Nurse-NP/PA. Tipping the food balance toward more red and processed meat significantly reduces the diet’s healthfulness, Dr Willett added. “Partially replacing red meat with nuts is the best health

bargain, as it increases health and reduces cost,” he said. Dr Willett’s team analyzed the food intake, caloric intake, and spending of the 78,191 women who responded to the Food Frequency Questionnaire of the NHS. The respondents with the lowest overall AHEI scores spent 24% less money daily on food prepared at home than did those with the highest scores. The latter group had higher intakes of healthful foods such as fruit, vegetables, poultry, fish, nuts, soy, beans, and whole grains, and lower intakes of red and processed meat, highfat dairy, and snacks and sweets. They also had lower rates of angina, diabetes, and hypertension. An extra $1 a day in spending for nuts, soy, and beans significantly increased the AHEI scores. In contrast, an extra $1 a day in spending for red and processed meat, high-fat dairy, or snacks and sweets significantly decreased the scores. The team concluded that the most healthful eating involves shifting purchases toward more nuts, soy, beans, and whole grains and away from highfat dairy and red and processed meat. ■

Mediterranean Diet Confers Protective Effects Against Obesity

eople who carefully follow a Mediterranean-type diet are not only less prone to chronic diseases, they also are likely to gain less weight than those who do not strictly adhere to a Mediterranean diet, a new study shows (Romaguera D, et al. Mediterranean dietary patterns and prospective weight gain change in participants of the EPIC-PANACEA project. Am J Clin Nutr. 2010;92:912-921. Epub 2010 Sep 1). In 10 countries, investigators sorted through data from 373,803 adults who participated in the EPIC-PANACEA (European Protective Investigation into Cancer and Nutrition-Physical Activity, Nutrition, Alcohol, Cessation of Smoking, Eating Out of Home and Obesity) study. The focus of this latest analysis was on the degree to which Mediterranean dietary pattern (MDP) adherence affects weight gain. Many studies have previously shown that the MDP is linked to lower incidence of chronic disease and a reduction in mortality rates, but this is the first study to show the protective effect of MDP against obesity. Dora Romaguera, PhD, of the Imperial College of London, and colleagues found that people who closely followed the MDP gained 0.16 fewer kilograms (0.36 lbs) over 5 years than

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did those who reported being lax in following the MDP. The pattern was maintained when the researchers calibrated the dietary data to take into account the subjects’ unintentional intake misrepresentations. Moreover, individuals who said they were MDP sticklers were 10% less likely to become overweight or obese than were those who followed the MDP loosely.

“If we consumed a diet similar to the Mediterranean diet but with a lot of meat, then probably we would no longer obtain beneficial effects against weight gain.” —Dora Romaguera, PhD “This shows that the consumption of a Mediterranean diet is related to less weight gain, which is consistent with other data….Thus, the findings are likely to be real and important,” commented Walter Willett, PhD, Chair, Department of Nutrition, and Fredrick John Stare Professor of Epidemiology and Nutrition, Harvard School of Public Health, Boston.

The MDP involves consumption of large amounts of olive oil, legumes, unrefined cereals, fruit, and vegetables, with a moderate consumption of dairy products—mostly in the form of cheese and yogurt—a moderate-to-high intake of fish, and a low intake of meat and meat products. On average, study participants gained 2.13 kg (4.77 lb) over the 5 years of follow-up, and that persons aged <40 years had the strongest weight-gain protection from the MDP, along with those who

were nonobese at the start of the study. Analysis of the contribution of each component of the Mediterranean diet to weight gain revealed that the only change capable of reversing the diet’s protective effect is to increase the intake of meat and meat products. “For instance, if we consumed a diet similar to the Mediterranean diet, but with a lot of meat, then probably we would no longer obtain beneficial effects against weight gain,” explained Dr Romaguera.—RF ■

Active Surveillance... Overall, 8 patients underwent surgery. Surgery was indicated in 2 patients because of interval growth; in the other 6 surgical patients, the decision for surgery was made by the patient. Only 1 patient had radical orchiectomy for pure seminoma after an interval growth from 3 mm to 6 mm at 3-month ultrasound; however, that patient has not had recurrent disease. The other 7 masses excised by partial orchiectomy were benign. Dr Toren emphasized that although the “particulars” of a surveillance strategy can only be determined using rigorous clinical data, he recommends

Continued from page 24

that most men with a small, nonpalpable lesion on their initial testicular ultrasound without “worrisome” ultrasound findings have a second ultrasound 1 month later and then again every 3 months for at least 6 months. Surgical excision should be reserved for men with a significant increase in the size of the testicular mass, or if patients are more comfortable with surgery than surveillance, he said. He urged clinicians to tell their patients that there is a lack of scientific evidence about the risk of testicular cancer associated with small testicular lesions. ■

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Nutrition

Moderate Caffeine in Pregnancy Not Linked to Miscarriage, Preterm Birth By Wayne Kuznar

regnant women can drink caffeinated beverages in moderation without fear of inducing miscarriage or preterm birth, according to a statement from the American Congress of Obstetricians and Gynecologists (ACOG), which defines moderate consumption as <200 mg of caffeine daily (ACOG Committee Opinion No. 462. Moderate caffeine consumption during pregnancy. Obstet Gynecol. 2010;116: 467-468).

Drinking <200 mg of caffeine daily during pregnancy appears to have no impact on the result of the pregnancy, but the effect on the intrauterine growth of the fetus remains unclear. No Significant Miscarriage Risk In assessing the risk for miscarriage from caffeine consumption, ACOG draws its opinion from 2 prospective studies in 2008 that together included >3000 women. In the first study, no association was found between any amount of caffeine consumption during early gestation and risk of miscarriage; in the second study, caffeine consumption of â&#x2030;Ľ200 mg daily doubled the risk of miscarriage compared with no caffeine intake, but smaller amounts of caffeine had no significant effect on the risk of miscarriage. Preterm Birth In addition, ACOG considered 2 studies that assessed the relationship between caffeine intake and preterm birth. In a randomized, double-blind study of 1153 women who reported drinking â&#x2030;Ľ3 cups of coffee daily and delivered live singletons, researchers found no evidence of an association between caffeine intake and gestation length. The control group drank only decaffeinated instant coffee and had an average caffeine intake that was 182 mg/day lower than the group that continued to drink caffeinated instant coffee. (Instant coffee contains an average of 76 mg of caffeine, according to the US Department of Agriculture; brewed coffee contains an average of 137 mg of caffeine.) Similarly, a prospective populationbased cohort study of 873 singleton births showed no association between caffeine consumption and preterm birth.

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Intrauterine Growth Restriction ACOG also investigated 2 studies in which the outcome of intrauterine growth restriction (IUGR) was assessed according to level of caffeine intake. A 2008 study of 2635 women

who were at 8 to 12 weeks of gestation showed either no significant increase or barely significant increase in the risk of IUGR with caffeine intake of â&#x2030;Ľ200 mg/day. However, an earlier (1993) prospective cohort study

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showed no association at all between caffeine intake and IUGR. ACOGâ&#x20AC;&#x2122;s statement concludes that the relationship between caffeine exposure and the risk of IUGR â&#x20AC;&#x153;remains undetermined.â&#x20AC;? â&#x2013;

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october 2010 I Vol 2, No 5

OBGYN_1010_OBGYN 10/19/10 9:44 AM Page 28

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Progesterone # Fact 5

Vis it u Bo s a oth t A #4 SRM 33