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CONTENTS

August 2010

Vol 2, No 4

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 MISSION STATEMENT The OB/GYN and Infertility Nurse is the official publication of the American Academy of OB/GYN and Infertility Nurses. The OB/GYN and Infertility Nurse provides practical, authoritative, cutting-edge information on the physiologic, medical, and psychological aspects of human reproduction, focusing on the role of the OB/GYN, infertility, and urology nurse in patient care.

Our journal offers a forum for nurses, nurse practitioners, physician assistants, administrators, researchers, and all others involved in OB/GYN, infertility, and urology to discuss the entire scope of current and emerging diagnostic and therapeutic options, as well as counseling and patient follow-up for men and women throughout their reproductive years and beyond.

Written by nurses for nurses, The OB/GYN and Infertility Nurse promotes peer-to-peer collaboration among all nursing professionals toward the advancement of integrated services for optimal care delivery.

The journal offers continuing education for all nurses involved in these interrelated fields of patient management.

The OB/GYN and Infertility Nurse, ISSN 2151-8394 (print); ISSN 2151-8408 (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 and Infertility 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 and Infertility 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 and Infertility 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 status is confirmed.

ASK THE EXPERT

4 Providing In Vitro Fertilization Success Rates to Patients CLINICAL NEWS

5 Pediatrics Group Retracts Policy against Genital Cutting Emergency Contraceptive Gets Unanimous Support from FDA Advisory Panel FDA Advisory Panel Rejects Drug Application for Female Sexual Disorder 19 College Women More Adherent to Contraceptive Ring than the Pill Women Prefer Home Testing for Sexually Transmitted Infections Having More Children Linked to Untreated Cavities 20 Pregnancy Increases Male Partner’s Risk for Contracting HIV from the Woman

6

EMERGING QUESTIONS

7 Commentary: Helping Patients Choose Contraception FDA Warns Against Use of Unapproved IUDs 14

THE OB/GYN NURSE

8 Recognizing Sexual Abuse 11 Antidepressant Use Early in Pregnancy Ups Miscarriage Risk 12 Breast Cancer Screening Premature Puberty in Children Linked to Estradiol Spray 13 Oncologists Try—But Fail—to Boost Mammography Rates 14 Bladder Cancer Update 16 Aromatase Inhibitors Can Resolve Endometrial Thickness from Tamoxifen

21

PHARMACY CORNER

16 Off-Label Use of Progestin-Based 17P for Prevention of Preterm Birth in High-Risk Women

ACOG HIGHLIGHTS

17 Preterm Birth Update 18 The Looming Shortage of OB/GYNs 20 New Findings Featured at ACOG

27

THE INFERTILITY NURSE

21 Legal Matters: Infertility Cases from Around the Globe 22 Hyperprolactinemia and Fertility 24 New Method to Predict IVF Success after First Failure Ovarian Insufficiency Linked to BRCA1 Mutation

THE UROLOGY NURSE

26 BPH Drug Improves Ejaculatory Dysfunction Anejaculation Common after Radiotherapy for Prostate Cancer

NUTRITION

27 Omega-3 Fish Oil Supplementation Reduces Symptoms of Major Depression Vitamin D Linked to Pelvic Floor Disorders in Women

SUBSCRIPTIONS/CHANGE OF ADDRESS should be directed to CIRCULATION DIRECTOR, The OB/GYN and Infertility Nurse, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831; Fax: 732-656-7938.

www.obgyN-iNfertility-Nurse.com

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From the Editors

Co-Editor-in-Chief Debra Moynihan, WHNP-BC, MSN Carolina OB/GYN

Ask the Expert

Co-Editor-in-Chief Sue Jasulaitis, RN, MS Fertility Centers of Illinois

By Sue Jasulaitis

Question: A patient recently asked me where to find a comparison of in vitro fertilization (IVF) success rates for US IVF centers. I was not aware that this information existed for patients. Can you tell me how I can best provide this information to our patients?

Answer: The Fertility Clinic Success Rate and Certification Act of 1992 (Wyden Act) mandates that clinics performing assisted reproductive technology (ART) procedures provide annual outcome data to the Centers for Disease Control and Prevention (CDC) for all cycles performed in the United States.

The CDC uses these data to report clinic-specific success rates. Since 1985, the Society for Assisted Reproductive Technology (SART) has been actively involved in the collection of cycle outcome data from SART member fertility programs. SART works in conjunction with the CDC to electronically collect and report clinic data from all ART pro-

EDITORIAL BOARD Co-Editor-in-Chief Debra Moynihan, WHNP-BC, MSN Women’s Health Nurse Practitioner Carolina OB/GYN, SC Co-Editor-in-Chief Sue Jasulaitis, RN, MS Clinical Research Manager Fertility Centers of Illinois, Chicago

4

cedures for SART member clinics. To allow ample time for birth outcomes, as well as data collection and management, outcome data are reported in a retrospective fashion. Currently, data are available for 2007 and 2008 ART cycles.

There are 2 ways to access this information. The first is through the CDC website (www.cdc.gov/art/ARTReports. htm). This website provides a summary of ART cycles in the United States, providing an in-depth report of the type, number, and outcomes of ART cycles performed in US fertility clinics.

It also includes individual clinic tables that provide ART success rates and other information from each clinic.

Kit Devine, MSN, ARNP Advanced Nurse Practitioner Fertility & Endocrine Associates, Kentucky Gina Paoletti-Falcone, RN, BSN Clinical Services Manager Freedom Fertility Pharmacy Byfield, MA Donielle Farrington, RNC Clinical Nursing Manager Brunswick Hills OB/GYN, NJ

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

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

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

Jennifer Iannaccone, RNC

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

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

August 2010 I Vol 2, No 4

Nursing Manager IVF Coordinator IVF New Jersey

Current data available are for 2007.

The second source for this information is through SART (www.sart.org/ find_frm.html). SART also releases a report outlining annual ART success rates. This report contains the same outcome data as the CDC report but is released a year sooner. The current SART report contains outcome data from 2008.

As accurately stated on the CDC website, many people considering ART may want to use these data at face value to find the “best” clinic available to them. “However, comparisons between clinics must be made with caution.

Many factors contribute to the success

Donna Makris, RN, BSN, IBCLC Parent Education Coordinator OB/GYN, St. Peter’s Medical Center, NJ Jill Marchetti, RN Director, Egg Donor Program IVF New Jersey Mary McGregor, RN IVF Coordinator The Fertility Institute of New Orleans Norah S. Nutter, MSN, WHNP-BC, IBCLC Women’s Health Nurse Practitioner Magnolia OB/GYN Myrtle Beach, SC Kutluk Oktay, MD, FACOG Professor of Obstetrics & Gynecology Director, Division of Reproductive Medicine & Infertility, Department of Obstetrics & Gynecology; Medical Director, Institute for Fertility Preservation, New York

Send questions to lara@novellushc.com of an ART procedure. Some factors are related to the training and experience of the ART clinic and laboratory professionals and the quality of services they provide. Other factors are related to the patients themselves, such as their age and the cause of their infertility.

Some clinics may be more willing than others to accept patients with low chances of success or may specialize in various ART treatments that attract particular types of patients.” The website highlights specific factors for patients to weigh when considering a fertility clinic. It is an excellent resource for patients seeking the best clinic for their reproductive needs.

Cyndi Gale Roller, PhD, RN, CNP, CNM Program Director Women’s Health College of Nursing Kent State University, OH Patricia Rucinsky, RN, BSN Clinical Nurse Manager IRMS, St. Barnabas, NJ 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 Joan Zaccardi, MS, DrNP Administrative Practice Manager Urogynecology Arts of New Jersey

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Clinical News Pediatrics Group Retracts Policy against Genital Cutting The American Academy of Pediatrics (AAP) has revised its recently updated policy on female genital cutting (FGC) to convey a clear message of no tolerance for the practice, after some backlash from a previous suggestion for harm reduction as suggested by an article in the New York Times (May 6, 2010).

Concern arose after the AAP’s Bioethics Committee published an updated statement (Committee on Bioethics. Pediatrics. 2010;125:10881093. Epub April 26, 2010) on FGC that proposed a less-harmful clitoral nick as a measure that would fulfill the rite of passage ritual and avert the potential dangers of girls being sent back to their native countries for more severe and dangerous cutting. “There is reason to believe that offering such a compromise may build trust between hospitals and immigrant communities, save some girls from undergoing disfiguring and life-threatening procedures in their native countries, and play a role in the eventual eradication of FGC,” the committee wrote originally.

The new statements from the group (Policy Statement. Pediatrics. 2010; 126:191. Epub June 7, 2010) clarifies their current position. “The AAP reaffirms its strong opposition to female genital cutting and counsels its members not to perform such procedures,” the group wrote in late May. “As typically practiced, FGC can be life-threatening. Little girls who escape death are still vulnerable to sterility, infection, and psychological trauma.”

Federal law prohibits any form of FGC, and the AAP is in no uncertain terms opposed to the practice in all forms, the group wrote in its revised statement.

OBGYN, Brown University, and chair of the advisory panel of the manufacturer, said the company presented adequate data, while saying, “Of course, there could always be more…but the data are very reassuring.”

FDA Advisory Panel Rejects Drug Application for Female Sexual Disorder Despite much-anticipated expecta-

tions for a positive response from the US Food and Drug Administration (FDA) to the new drug application for flibanserin (Girosa) 100 mg—a 5hydroxytryptophan (HT) 1A receptor agonist and 5-HT 2A receptor antagonist—for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, the FDA Reproductive Health Drugs Advisory Committee put an end to the speculations in

June. After much debate and an initial positive response, the committee voted overwhelmingly to reject the application, stating that flibanserin was not superior to placebo in treating HSDD, and that the drug’s benefits did not outweigh its adverse effects, which include loss of consciousness and depression.

First developed as an antidepressant, flibanserin was expected to become the Continued on page 19

Emergency Contraceptive Gets Unanimous Support from FDA Advisory Panel If the US Food and Drug Administration (FDA) follows the advice of its Advisory Committee for Reproductive Health Drugs, ulipristal acetate 30-mg tablets will become the newest US option for emergency contraception.

The committee voted unanimously on June 17 in favor of the novel drug’s efficacy and safety after reviewing the clinical trials data for ulipristal acetate, which enrolled more than 4000 women from the United States and Europe.

Approved last year in Europe as an emergency contraceptive for use within 120 hours of unprotected sex or contraceptive failure, ulipristal acetate is being marketed in 22 European countries under the brand name ellaOne. If approved in the United States, the manufacturer intends to market it under the name ella.

Sandra Carson, MD, Department of

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Emerging Questions

What Is the Safest Contraceptive... factors, such as effectiveness, availability, and acceptability are also important in optimizing the choice. The CDC guidelines can help guide providers in personalizing this important component of women’s care. The Table discusses the meaning of and precautions for each category applied to all contraceptive methods.

Postpartum Patients No hormonal or intrauterine devices (IUDs) are off limits postpartum, except for IUDs in women who have had puerperal sepsis. For women who are at least 1 month postpartum, the methods with the strongest recommendations (category 1) for breastfeeding women include the progestin-only pill (POP), depot medroxyprogesterone acetate (DMPA) injections, etonogestrel implants, and the copper intrauterine device (Cu-IUD); the combined oral contraceptive/patch/ ring (COC/P/R) and levonorgestrelreleasing intrauterine device (LNGIUD) are category 2, because their advantages are considered to generally outweigh their risks. For women who are not breastfeeding, the recommendations are the same, except that COC/P/R becomes category 1 after 21 weeks postpartum.

In the immediate postpartum period (up to 1 month), POP, DMPA, and implants are category 2 and COC/P/R are category 3.

Immediate postpartum Cu-IUD insertion is associated with a lower expulsion rate compared with delayed insertion up to 72 hours postpartum.

There are no data examining times beyond 72 hours, and no evidence is available comparing different insertion times for the LNG-IUD. Reproductive Tract Disorders The preferred methods of contraception are detailed according to vaginal bleeding patterns, endometriosis, reproductive tract malignancies, benign tumors, gestational trophoblastic disease, cervical neoplasias and ectropion, uterine fibroids, anatomic abnormalities, pelvic inflammatory disease (PID), and sexually transmitted infections (STIs).

For most of these conditions, all contraceptive choices are acceptable. The exceptions are: • Unexplained vaginal bleeding (suspicious for a serious condition)—IUDs are not recommended • Gestational trophoblastic disease with persistently elevated beta-hCG levels or malignancy—IUDs are not recommended • Cervical cancer (awaiting treatment)— initiation of IUDs is not recommended but continuation is acceptable

• Breast cancer—for current patients with cancer and those with a history of breast cancer, no hormonal contraception or LNG-IUD is considered safe; instead, the Cu-IUD is recommended (category 1); for women with breast cancer, hormonal methods and LNG-IUD pose unacceptable risk (category 4); for women without active disease for at least 5 years, the risks still outweigh the benefits (category 3) • Patients with ovarian cancer—hormonal methods are safe (category 1); IUDs should not be used • Anatomic abnormalities—IUDs should not be used for women with distorted uterine cavities; for those with other abnormalities not distorting the uterine cavity or interfering with IUD insertion, IUDs are acceptable (category 2) • PID—is a contraindication for initiating an IUD but continuation of IUD is acceptable; for women with a history of PID (assuming no current risks for STIs), all contraceptive methods are category 1 • STIs—women with current purulent cervicitis, chlamydial infection, or gonorrhea should not be started on an IUD but continuation is acceptable; it is controversial to initiate an IUD in women at increased risk for STIs (category 2/3), although continuation is acceptable (category 2).

Thromboembolism For women with a history of deepvenous thrombosis (DVT) or pulmonary embolism (PE) who are not

Continued from page 1

Table Risk/Benefit Categories for Hormonal Contraceptives, IUDs Safety category Risk level 1

No restriction for the use of the contraceptive method

2

The advantages of using the method generally outweigh the theoretical or proven risks

3

The theoretical or proven risks usually outweigh the advantages of using the method

4

An unacceptable health risk if the contraceptive method is used

IUDs indicates intrauterine devices.

receiving anticoagulant therapy, CuIUD is considered the safest method (category 1). This is true for women deemed at high risk for recurrent DVT/PE (ie, at least 1 risk factor) and at lower risk (ie, no risk factors). Risk factors include history of estrogenassociated DVT/PE, pregnancy-associated DVT/PE, idiopathic DVT/PE, known thrombophilia, and active cancer (ie, metastatic, on therapy, or within 6 months after clinical remission).

COC/P/R has category 4 status for the higher-risk group and for patients with acute DVT/PE, and category 3 status for the lower-risk group. All other methods are category 2.

For patients using anticoagulant therapy for at least 3 months, all methods are category 2 (including Cu-IUD),

The CDC Guidelines: Practical Implications

A

ndrew Kaunitz, MD, Professor and Associate Chair, OB/GYN Department, University of Florida College of Medicine, Jacksonville, who participated in the development of the guidelines, commented on their practical implications for practitioners.1 “Package and labeling for contraceptive injections (as well as the implant) inappropriately list ‘a history of deep-venous thrombosis (DVT)’ as a contraindication. Both the WHO (World Health Organization) and the CDC (Centers for Disease Control and Prevention) guidelines, along with those from the American Congress of Obstetricians and Gynecologists, state that it is reasonable to use progestin-only methods for women with a history of DVT or PE [pulmonary embolism],” he said.1 Unlike the WHO, the CDC says it is appropriate to prescribe progestin-

only methods—mini-pills, injections, the implant, and the levonorgestrel intrauterine system—in women with thrombosis or a history of thrombosis, he explained.

He noted that women with a history of DVT are often referred for birth control. “If such women choose injectable or implantable contraception, I clarify that…it is consistent with available evidence.”1 Another clinically useful recommendation, he noted, is the use of progestin only shortly after delivery for nursing mothers. Unlike the WHO, the CDC’s guidelines support the initiation of progestin-only contraceptives in nursing women <1 month postpartum, he said. ■ Reference 1. Kaunitz AM. Contraceptive use: new clinical guidance from the CDC. Medscape, June 25, 2010. www.medscape.com/viewarticle/723917. Accessed July 16, 2010.

except COC/P/R, which is not recommended at all (category 4) in higherrisk patients and is category 3 in lowerrisk patients.

For women with a first-degree relative with DVT/PE and for those with superficial venous thrombosis, all methods are acceptable. This is also the case for women undergoing minor or major surgery that does not require immobilization. Should prolonged immobilization be necessary, however, these patients should avoid COC/P/R, as should women with known thrombogenic mutations, such as factor von Leiden and antithrombin deficiencies.

Cardiovascular Issues COC/P/R should not be prescribed to women with current ischemic heart disease, a history of ischemic heart disease or stroke, complicated valvular heart disease (ie, pulmonary hypertension, risk for atrial fibrillation, or history of subacute bacterial endocarditis), or peripartum cardiomyopathy.

This method is more controversial (category 2/3) for women with known hyperlipidemia. All other methods are acceptable in these groups and for women with uncomplicated valvular heart disease.

Any method is acceptable for women with diabetes that is nonvascular (insulin-dependent or non–insulindependent) or in those with a history of gestational diabetes, but COC/P/R should not be prescribed to patients with diabetes of at least 20 years duration, other vascular conditions, or complications from diabetes. Other methods are acceptable, but only the Cu-IUD is category 1.

For women with multiple risk factors for cardiovascular disease (eg, older age, smoking, diabetes, hypertension), COC/P/R is not recommended, nor Continued on page 7

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Emerging Questions

What Is the Safest... is DMPA. The POP, etonogestrel implants, and LNG-IUD are acceptable (category 2), but the Cu-IUD is preferred (category 1).

Women with hypertension—whether adequately controlled or not—should not receive COC/P/R (category 3/4), but those with a history of high blood pressure during pregnancy can be prescribed any method.

Rheumatic Diseases Systemic lupus erythematosus (SLE) with positive or unknown antiphospholipid antibodies is a contraindication for COC/P/R (category 4), for POP (category 3), and for LNG-IUD (category 3). The Cu-IUD is a safe (category 1) option in this group. For patients with SLE and severe thrombocytopenia, DMPA and LNG-IUD should be avoided. For SLE patients on immunosuppressive treatment and for those without antibodies or severe thrombocytopenia, any method is acceptable. For patients with rheumatoid arthritis, POP, etonogestrel implants, and IUDs are safe (category 1); COC/P/R is category 2; and DMPA is controversial.

Neurologic Conditions Any method is acceptable for women with headaches that are not migrainous, but those with migraines should probably avoid COC/P/R. This method is contraindicated for migraine with aura, as is POP. For women without aura who are older than 35 years, COC/P/R is also contraindicated, but the recommendation is less stringent for younger women (category 2/3). The Cu-IUD is the only method with a category 1 recommendation in these women. All methods are considered safe for women with epilepsy or depression, although providers should consult the CDC document for possible drug interactions with anticonvulsants.

Continued from page 6

Cigarette Smokers The only method not recommended for these women is COC/P/R for those aged ≥35 years who smoke ≥15 cigarettes daily (category 4) or <15 cigarettes daily (category 3). Younger women who smoke can receive a COC/P/R (category 2), although other methods are preferable (all category 1).

Miscellaneous Conditions A number of conditions are common among women and can affect the choice of contraception. Although COC/P/R is acceptable for women with inflammatory bowel disease, there is some controversy (category 2/3); all other methods are category 2, but the Cu-IUD is the preferred choice.

All methods are safe (category 1) for women with thyroid disorders, those with chronic viral hepatitis or those who are carriers and have mild cirrhosis, women taking antimicrobial therapy (except rifampicin or rifabutin, in which case DMPA and IUDs are preferred), and those with irondeficiency anemia.

For women with HIV infection or AIDS, or those at risk for HIV, all hormonal methods are safe (category 1) and IUDs are category 2. There are some possible drug interactions with antiretroviral therapy, and the CDC guidelines should be consulted on this issue. ■ References 1. Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion; Centers for Disease Control and Prevention, Farr S, Folger SG, Paulen M, et al. U.S. medical eligibility criteria for contraceptive use, 2010: adapted from the World Health Organization. Medical Eligibility Criteria for Contraceptive Use, 4th ed. MMWR Recomm Rep. 2010;59:1-86. www.cdc.gov/mmwr/pdf/rr/rr59e0528.pdf.

Accessed July 18, 2010.

2. Department of Reproductive Health, World Health Organization. Medical Eligibility Criteria for Contraceptive Use, 4th ed, 2009. Geneva, Switzerland: World Health Organization; 2009. www.who.int/reproductivehealth/ publications/family_planning/9789241563888/en/ index.html. Accessed July 16, 2010.

COMMENTARY

Helping Patients Choose Contraception

By Debra Moynihan, WHNP-BC, MSN Carolina OB/GYN, SC

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ot all birth control is created equal. When assisting patients in choosing the most appropriate contraceptive method, it is very important to obtain a complete medical history. Age and sexual history are also factors to be considered.

In older women (≥35 years old), who may be a little more responsible, birth control pills may be a viable option, but you will want to make sure the patient does not smoke, has normal blood pressure, and has no risk factors for blood clots or stroke. She should also not have breast cancer (known or suspected), severely impaired liver function, or elevated lipids (ie, cholesterol or triglycerides). Depending on her age and the number of children she has delivered, the older female may benefit from permanent sterilization, or an intrauterine device (IUD) if she is in a monogamous relationship.

Younger women (<35 years old) have other factors to consider when choosing contraception, even though most of them are healthy. For example, many younger patients find Depo Provera convenient, because it is given as an injection every 3 months. With this method, they do not have to remember to take their birth control daily. When prescribing Depo Provera, it is important to know if the patient smokes, consumes alcohol chronically, or has a history of anorexia. A family history of osteoporosis is another risk factor, because Depo Provera has been shown to decrease bone mineral density with extended use, especially when patients have additional risk factors.

Younger patients are often a little

FDA Warns Against Use of Unapproved IUDs

T

he purchase, use, and distribution of unapproved intrauterine devices (IUDs) by some medical facilities in the United States prompted a warning letter from the US Food and Drug Administration (FDA) on July 22, after an investigation in several states.

The FDA is advising healthcare practitioners to avoid unapproved IUDs and spread the word to colleagues and patients for the following reasons: • The potential lack of safety and

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efficacy of these products, particularly the risk for failed pregnancy prevention • Negative public health effects associated with IUDs that were not manufactured or handled according to FDA standards • Insurance fraud is a risk, particularly in Medicaid.

The FDA urged those purchasing IUDs online to ensure that they only deal with state-licensed distributors or pharmacies within the United States,

because products that do not meet these criteria can be harmful and purchasing them can be illegal.

The FDA is asking individuals who have information about the distribution of unapproved IUDs to report it to the administration’s Office of Criminal Investigations (www.fda. gov/ICECI/CriminalInvestigations/ default.htm, under “Report Suspected Criminal Activity.”)

Obtaining a complete sexual history, including number of partners and condom use, is very important. more promiscuous. The use of an IUD is therefore usually not recommended, because of the risk for ascending infection from the strings if the woman contracts chlamydia or gonorrhea. Obtaining a complete sexual history, including number of partners and condom use, is very important.

Young women do well physically with birth control pills, but many are not dependable about taking them on schedule, which puts them at risk for an unwanted pregnancy. Before prescribing the pill, you should try to ascertain how responsible the patient is in this regard, and review her medical history and medication use. Certain drugs, such as anticonvulsants and antimicrobials, can lead to increased metabolism of oral contraceptives. ■

Coming in October Complimentary CEU Credit • Ectopic Pregnancy AWHONN Coverage Meeting Highlights

•

Clinic Profile • Genetics & IVF Institute, Fairfax, VA Infertility in Focus • Vitrification of Blastocysts

August 2010 I Vol 2, No 4

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The OB/GYN NurseClinic

Recognizing Sexual Abuse Cyndi Roller, PhD, RN, CNM, CNP Program Director, Women’s Health, Kent State University College of Nursing, OH

S

exual abuse is a common problem affecting millions of women at different stages of their lives. A large study published in 2007 indicated that 11.7 million American girls and women were sexually abused during 2001-2003, and 64% of them were teenaged (≤17 years) at the time of the first abuse.1 Nevertheless, the issue of sexual abuse is usually ignored by clinicians—physicians and nurses alike.

Indeed, across the board—in the gynecologic, the obstetric, and the infertility setting—professional people have an excuse for why they cannot address sexual abuse and sexual violence. A lot of people are very uncomfortable talking about it. The problem is, if we shy away from the topic of sexual abuse, we never come to the point of addressing it.

Red Flags for Sexual Abuse in Women I have done a pilot study (that included 15 women) on how women survivors of sexual abuse manage the perinatal period. In that study I found that these women manage the problem by avoiding the pain. They do whatever they need to do not to experience that pain

of the flashback. For that reason, they often do not get prenatal care, and they use substances to “block out” the pain.

Many of them use that phrase, “I needed to get high so I could ‘block out’ what happened to me.” They all say that they may forgive, but they never forget.

I heard a case report of a woman who got married but never had intercourse.

She did not want to be touched, but she wanted children. She went to an infertility doctor, who did artificial insemination with her husband’s sperm. Not surprisingly perhaps, she wanted to deliver by cesarean surgery, to avoid a vaginal delivery. When I heard this, I said, “My goodness! This woman has clearly experienced the trauma of sexual violence somewhere along the line.”

She was never asked. Often the red flag is there, but people are not asking the necessary questions.

Another case is a girl who was seen by one of my students. It was an 11-year-old girl, who presented with vaginitis. I asked the student, “Did anybody screen her for sexual violence?” The answer was, “Well, no.” My immediate response was, “What do you mean ‘well, no’?” All nurses should know that 11-year-old

All nurses should know that 11-year-old girls do not get vaginitis. That’s a clear red flag that should elicit questions about sexual violence or abuse. girls do not get vaginitis, unless maybe they have diabetes or something like that; 11-year-old girls should not be getting vaginitis. That’s a clear red flag that should elicit questions about sexual violence or abuse.

A New Screening Tool Those who are working with women in the gynecologic setting or the infertility setting must be aware of the possi-

bility that their patient has been sexually traumatized, because that has direct implications for the condition of or treatment for the patient. They must be willing to address this issue. But how should you address it? You cannot just say to patients, “Have you ever been abused?” or, “Is somebody touching you in a way that you do not want?”

A group of my colleagues and I developed an assessment tool—the SATELLITE—that offers a protocol for screening for sexual violence for women in the perinatal period (Figure).2 I believe that this assessment guide can be adapted into the women’s healthcare setting to screen all women. It can certainly be adapted for women in the obstetric setting, in the hospital, and in the outpatient settings.

We have included specific scripts, so it gives you the words you can use, as well as instructions for what to do when you find out that a patient was or is a victim of sexual abuse. You also need to know what is going on legally, as well as the laws in your state, in terms of what to do when you have a woman who tells you that she has been sexually abused.

If sexual violence is confirmed, the best thing to do is refer the patient to a trauma therapist. It is not enough just to send the patient to any therapist; you Continued on page 9

New Diagnostic Criteria for Gestational... adverse pregnancy outcomes from the HAPO study, which showed that the risks for maternal, fetal, and neonatal problems increased gradually as the pregnant woman’s glucose levels increased, even within ranges previously considered normal for pregnancy.

In contrast, in the previous diagnostic criteria, 2 of 3 blood glucose values had to be elevated on a glucose tolerance test to establish a diagnosis of gestational diabetes. The new glucose level cutoffs are also a bit lower than the previous criteria. The lower cutoffs define the glucose levels at which the risk for a fetus having diabetes-related complications during pregnancy increased by 75%.

“All 3 values must be normal to have normal glucose tolerance,” Ms Jornsay said. The fasting glucose criterion alone identifies gestational diabetes in 8.3% of pregnant women; adding 1-hour plasma glucose increases the rate to 14%, and adding a 2-hour plasma glucose identifies 16.1%, she said.

According to the new strategy, glucose levels should be rechecked at 24 to 28 weeks with an oral glucose tolerance test if the initial test results are below the cutoffs for gestational diabetes.

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Screen All Pregnant Women “If any one of those tests is positive for overt diabetes, treat as existing diabetes, not gestational,” she said. The new screening strategy recommends screening all women at their initial prenatal visit using the criteria to diagnose diabetes in the general population, with the goal of identifying undiagnosed diabetes. If the woman already has diabetes, her blood glucose must be controlled. A full glucose tolerance test is then suggested in the second trimester of pregnancy.

Estimates from the HAPO study state that about twice as many women would be diagnosed with gestational diabetes based on the new criteria than are diagnosed using the old ADA criteria.

Drug Therapy No oral antidiabetic agents have received approval from the US Food and Drug Administration for use during pregnancy, although some are often used off-label for this purpose. Sulfonylureas and metformin should be avoided during pregnancy; sulfonylureas may cause fetal malformation and metformin is associated with preeclampsia and stillbirth.

Continued from page 1

Glyburide appears safe, because it appears to minimally cross the placental barrier and is absent in cord blood, Ms Jornsay said. There have been no studies of thiazolidinediones, meglitinides, or alpha-glucosidase inhibitors during pregnancy.

“All 3 values must be normal to have normal glucose tolerance.”

—Donna Jornsay, RN, PNP-C

Although HAPO revealed that the risk of fetal complications increases at glucose values lower than those in the old gestational diabetes diagnostic criteria, it did not provide any evidence that treating glucose levels can reduce the risk of complications.

Mother’s “Diabesity” A new analysis of the HAPO study presented at the 2010 ADA meeting showed that gestational diabetes and

obesity, either separately or in combination (ie, “diabesity”), are strongly associated with an increased frequency of macrosomia, said lead investigator Boyd E. Metzger, MD, Professor of Metabolism and Nutrition, Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University, Chicago, IL. Dr Metzger and colleagues examined the relative contributions of gestational diabetes and maternal obesity to risk of macrosomia, defined as a birth weight ≥4000 g. Maternal body mass index was classified as nonobese or obese by modification of the 2009 Institute of Medicine recommendations.

“Obesity was associated with a 2-fold higher frequency of macrosomia,” regardless of whether the women had gestational diabetes, Dr Metzger said.

The observed number of macrosomia cases in the nonobese group with gestational diabetes was 286, compared with an expected number of 186, for an excess number of 100 cases.

In the 380 total excess cases of macrosomia, gestational diabetes only was present in 26%, gestational diabetes plus obesity was present in 33%, and obesity only was present in 41%. ■

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The OB/GYN Nurse Recognizing Sexual Abuse... need to send her to someone who is trained in dealing with trauma.

Start Asking Unpleasant Questions I would like to see nurses start using the SATELLITE, because if you do not ask questions, you are never going to get the answers. The literature suggests that of the women who have experienced childhood sexual abuse, one third will experience adult revictimization.

Continued from page 8

In my Women’s Health Nurse Practitioner Program at Kent State University, we teach students about sexual violence; not only childhood sexual abuse but also intimate partner abuse. We teach them to ask questions, because the question has to be asked all the time. Especially with new patients, you have to ask the question.

I am currently working on a checklist to have in the clinical setting so that we

can look at all the factors that are predictive of women who have experienced childhood sexual abuse, and will be predictive of whether they receive good perinatal care.

We also have to develop interventions to help these women, because often they do not get good prenatal care. A lot of these women do not bond well with their children, and we see the cycle repeating. Of the 15 women who

participated in my study, 3 already told me that their children had been sexually abused. If we do not do something, it is just going to get worse and worse. ■ References 1. Basil KC, Chen J, Black MC, Saltzman LE. Prevalence and characteristics of sexual violence victimization among US adults, 2001-2003. Violence Vict. 2007; 22:437-448.

2. Ross R, Roller C, Rusk T, et al. The SATELLITE sexual violence assessment and care guide for perinatal patients. Women’s Health Care. 2009;8:25-31.

% Figure. SATELLITE Sexual Violence Assessment and Care Guide for Perinatal Patients

SATELLITE STEP

ACTIONS

NP CHECK OPTIONS

Prepare yourself

_____

Know your area resources, including hotlines, support groups, battered women’s shelters, rape crisis services, and trauma counseling services.

Search for support organizations or groups in your state at eHow: www.ehow.com/how_8564_find sexual-abuse.html

Prepare the environment

_____

SV educational materials can be obtained from the CDC: www.cdc.gov/ncipc/dvp/SV/default.htm or from the NY State Coalition Against Sexual Assault: www.nsvrc.org

Approach

Develop rapport; Foster trust; Balance professionalism, friendliness; Ensure privacy

_____

Introduce yourself, maintain focus on the patient rather than on tasks.

“It is the policy of this clinic that we excuse partners/family during examinations.”

Ask

Introduce the topic

_____

“Sexual violence is common among women of all races and backgrounds; therefore, it is routine for us to ask every woman if she has experienced any sexual violence in her life.”

“I ask all of my patients these questions because I need to know what has gone on and what is going on in their lives. For instance, someone can be traumatized by experiencing sexual violence.”

“Because violence is so common in many women’s lives and because help is available for women who are being abused, I ask every patient about sexual violence.”

• If positive screening–“Has anyone at home, work, or school touched you in a way that made you uncomfortable?”

• “When you think about your earliest sexual experience, would you say that you wanted that experience?”

• “Has anyone forced you to have sexual activities that made you feel uncomfortable?”

Assess

Look for “red flags”

_____

Common “red flags” during vaginal examinations include exaggerated response to touch, crying, screaming, pushing away hands/tools, cramping legs, and jumping off the table.

• If “red flags” are noted, stop the procedure.

• Ask “What’s happening?”

• Ask “Is this procedure triggering your memory about something that bothers you?” or say, “I am concerned that your behavior may be caused by someone hurting you.”

Treat

Thank the patient for sharing the information

_____

“Thank you for trusting me and letting me know about your experience.”

“I am sorry that happened to you. It must be difficult for you.”

Reassure her that the violence was not her fault

_____

“This should not happen to anyone and it is not your fault. No one deserves to be abused—no matter what.”

Empower the patient by giving her control

_____

Allow the patient to wear her clothes rather than undressing. Provide individualized care (use smaller speculum, explain the procedure and sensations of the pelvic exam, spend more time during the procedure, allow the patient to walk during labor rather than being restricted to bed for monitoring).

Assist the patient to connect with person/agency

_____

Provide contact information for SANE nurse, trauma counselor, or SV support group.

Take notice of patient’s reactions, especially those that indicate she wants to talk more

_____

Remember to raise the issue of possible SV at subsequent encounters with the patient.

Evaluate patient’s safety

_____

If unsafe, inform social worker/contact shelter

_____

“Are you safe now?” “Have you been in a relationship with a partner in the past year?”

• If “yes” – “Within the past year or since you became pregnant, has a partner hit, kicked, pushed, choked, or punched you?”

• “Has such violence increased in frequency and intensity?”

• “Has he threatened to kill you?”

• “Do you believe that he is capable of doing so?”

Know your state laws Report when required by state law

_____ _____

State laws are summarized at the Domestic Violence and Sexual Assault Data Resource Center: www.jrsainfo.org/dvsa-drc/state-summaries.shtml

_____

Use the educational materials obtained during the preparation step. Make certain that the materials are updated as needed.

_____

Include observations on injuries related to the SV experience and behaviors related to the examination.

Setting

S

A

T Evaluate

E LLI TE

Laws, Legal Implications

Educate Thorough Education and Documentation Document assessment and interventions

Adapted with permission from Ross R, et al. The SATELLITE Sexual Violence Assessment and Care Guide for Perinatal Patients. Women’s Health Care. 2009;8:25-31.

CDC indicates Centers for Disease Control and Prevention; NP, nurse practitioner; SANE, sexual assault nurse examiner; SV, sexual violence.

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August 2010 I Vol 2, No 4

9

Clinic Profile

Women’s Health Specialists... that the care that is given is appropriate.

We also strive to give women more information than they came in for. For example, if they came in to get a Pap smear or to get birth control, they are given the opportunity to see their own cervix or get information about home remedies and referrals to other healthcare that they may desire. We give women the information that will help them to make the best decisions.

Parallel to that, we have educational sessions on self-help in the community that are informational and are not part of the clinic’s medical services.

Each of our 4 clinics has nurses who can provide services for our clients. We also have doctors who live in some of our communities and travel up to the

Has the clinic’s mission changed since its inception in 1975?

Our mission remains the same. We added a name in the mid- to late1990s—Women’s Health Specialists.

We are still Feminist Women’s Health Centers of California, originally incorporated as Chico Feminist Women’s Health Center. A key to who we are is that we view women’s bodies as normal, and our goal is to share tools with women so that they will view their bodies and body functions as normal, including menstruation and menstrual cramps, fertility, and menopause. Our goal is to share information and support women through all their life stages, as well as to provide well-woman services.

For example, when a woman comes to our clinic, or even to our website (www.cawhs.org), she has the option of learning breast and vaginal self-examination. Some women want to take home a speculum. After looking inside her vagina and looking at her cervix here at the health center, which is an option, the woman may want to do so at home. Some women use the speculum to look for signs of fertility, such as normal cervical secretions throughout the month, or to do self-examination even if they are not looking for signs of fertility. That would be an example of something that is often shared among feminist health centers, and is something that we offer along with a more standard medical care, such as Pap smears, screening for STDs, and birth control services. We have also added well-male services.

Can you talk about the clinic’s history?

The clinic was started by laywomen to offer the care that they wanted to receive. It was based on self-help and women teaching women, looking at their cervixes and looking to see what was normal for them. We opened in 1975 as licensed community clinics in Chico, CA, and expanded to Redding, Sacramento, and Santa Rosa. We created a model using a team comprised of nurses, nurse practitioners (NPs), doctors, and health educators. We hold true to self-examination and learning about one’s own body in nonmedical terms.

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August 2010 I Vol 2, No 4

Community health education is a cornerstone of the Women’s Health Specialists’ mission.

northern part of the state to provide abortion and colposcopy services to the women in rural northern California.

Birth control and reproductive health concerns are a big part of what people come to us for, but we provide a full range of women’s health services.

We were able to add more men’s services when the state started reimbursing for men’s services.

What is the role of lay women and professionals in the organization?

To this day, we are women running the health centers. What we have is a women-controlled clinic, as opposed to the doctor’s office model. What we have done in a participatory way is have the needs of the women who use our services be reflected in how we set up the clinic structure. Our clinic model is one in which we have hired doctors and nurses, and we bring on health educators who are laywomen and who are very interested and motivated to do outreach in the community and share health education.

We work as a team, and the physicians are in charge of, and supervising all of, the medical care. The nurses and NPs do a lot of the well-woman care— the family planning, birth control, Pap smears, STD screening, and much of the health education along with the health educators, who also provide support, and offer instruction on selfexamination.

Most of our well-woman healthcare services are provided by our NPs, our certified nurse midwives, and physician assistants, the advanced practice clinicians. That is an important part of our clinical care. We are recruiting for NP positions open in northern California.

Our medical director is an OB/GYN, but we are not an OB/GYN practice.

Continued from page 1

What types of services do you offer?

We have a full range of women’s health services in the well-woman model. We help women evaluate their healthcare needs, and offer home remedies, medical remedies, or sometimes just information. We specialize in first examinations in teenagers and sharing information with them.

We offer much more than birth control services. We have a women-centered adoption program, where we work with adoptive families and pregnant women who are considering placing their babies for adoption. Our mission is to help that woman reach her goal, whatever it may be—getting information or getting medical services.

Another part of our mission is demystifying our bodies. “Where is the cervix? Where is the uterus? Where does our menstrual period come from?

What does it mean when we are feeling breast lumps, but they may be there from month to month? Is it normal?”

These are questions that we have all had at some point in life. We help women learn about their bodies and sort that out.

The nurses and NPs do a lot of the well-woman care—the family planning, birth control, Pap smears, STD screening, and much of the health education.

We support the demystification of birth, and normal and natural pregnancy and information about birth, as well as doing a lot of referrals for OB/GYNs and midwives for prenatal care and birth. We advocate for women who come into the clinic—and in classrooms and in community groups—for people to get the information they need to make their own healthcare decisions, and we do it in a collaborative way with our health educators, nurses, and doctors.

As a larger organization collectively with the Federation of Women’s Health Centers, we have published books on women’s health—A New View of a Woman’s Body (1981), A WomanCentered Pregnancy and Birth (1984), and How to Stay OUT of the Gynecologists’ Office (1981).

When one of your patients becomes pregnant, do you refer her to a different clinic?

If she wanted to continue her pregnancy, then we would refer her to another clinic or to a doctor’s office for

obstetric care. If she did not want to continue her pregnancy, then she could stay with us, because we do provide abortion services. Abortion is an important part of our services. We do not want to stigmatize abortion. It is a normal service, but it is not the majority of what we do. Mainly, people come in for family planning birth control.

More than 30% of women in the United States have 1 or more abortions during their lifetimes (www.guttmacher. org/pubs/fb_induced_abortion.html).

This is part of women’s health. These are the same women who give birth, come in for contraception, and come in for breast examinations. These are women of all political and religious backgrounds.

Every community has people in support of abortion and people who are antiabortion, and we have both in all 4 of our communities, but even in our most rural clinic in Redding we have a lot of community support for our clinic.

We have national support and support from our elected officials, but there are always going to be people and groups working against us.

We have had arson, violence, and intimidation. We have picketing weekly in front of our sites, and we have also gone to court to obtain injunctions to limit the activities of the protesters at all of our sites. Unlike some states, in California there are a number of clinics and doctor’s offices that provide abortions.

Can you describe your patient population?

We are open to all women, and we take insurance. We have a sliding scale. But more and more over the decades, the women in the communities in which we reside are using MediCal and the Family PACT [Planning, Access, Care, and Treatment] free birth control program, paid for by the state of California, because they are income eligible.

Probably 90% of our clients are at less than 200% of the income rate on the federal poverty level scale. We do a lot of health education along with that, about STDs, pregnancy, and pregnancy prevention.

We do not target special populations.

We do outreach in our communities— through word of mouth and doing presentations at community groups—and we do community events. Our roots in the community and our geographic locations bring in many women and men from rural and underserved areas.

Our goal of offering all options for all women, and our dedicated staff, continue to make positive differences in all of our communities. ■

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The OB/GYN Nurse

Antidepressant Use Early in Pregnancy Ups Miscarriage Risk

By Wayne Kuznar

T

he use of antidepressants during pregnancy—particularly paroxetine (Paxil), venlafaxine (Effexor), or a combination of different classes of antidepressants—significantly increased the rate of miscarriage in a recent Canadian study (NakhaiPour HR, et al. Use of antidepressants during pregnancy and the risk of spontaneous abortion. CMAJ. 2010;182: 1031-1037).

Previous data have shown that up to 3.7% of pregnant women will use antidepressants during their first trimester.

Discontinuing an antidepressant during pregnancy leaves women vulnerable to relapse of depression, putting the mother and fetus at risk, researchers stated. In addition, 1 in 4 pregnancies “ends in a clinically apparent spontaneous abortion,” Dr Nakhai-Pour and colleagues wrote.

However, the majority of previous studies on the use of antidepressants in pregnancy did not look at spontaneous abortion as a primary outcome and had small samples, the study investigators note, and the findings of 2 recent reviews that assessed for exposure to antidepressants during early pregnancy and the risk of spontaneous abortion were contradictory.

ciated with a 68% increased risk for spontaneous abortion.

The use of SSRIs alone increased miscarriage risk by 61%, the use of venlafaxine alone doubled the risk, and the use of more than 1 class of antidepres-

sants more than tripled the risk of spontaneous abortion compared with no antidepressant use. “The risk of spontaneous abortion associated with these 3 categories of antidepressant use was significantly higher than with tricyclic

antidepressants or other antidepressants alone,” the investigators pointed out.

When examined according to specific antidepressant, paroxetine use alone and venlafaxine use alone were indeContinued on page 12

SSRIs, especially paroxetine and venlafaxine, as well as a combination of antidepressant classes, were associated with increased risk for spontaneous miscarriage.

Using the Quebec Pregnancy Registry, these researchers examined data for 5124 women who had a clinically detected spontaneous abortion at up to 20 weeks gestation. For each of these cases, 10 controls of matched gestational age who did not have a miscarriage were randomly selected from the remaining study population.

The antidepressants studied were selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (venlafaxine), and “other antidepressants.”

Of the women who had a miscarriage, 284 (5.5%) had prescriptions filled for antidepressants during their pregnancy compared with 2.7% of the matched controls. After adjusting for potential confounders, the use of antidepressants during pregnancy was asso-

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August 2010 I Vol 2, No 4

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The OB/GYN Nurse

Breast Cancer Screening

Ultrasound and MRI Are Helpful in High-Risk Women

By Caroline Helwick

R

ecent debate has highlighted the fact that screening for breast cancer is an imperfect science.

Efforts to improve screening using current modalities were reported at the 2010 San Antonio Breast Cancer Symposium.

A Canadian study confirmed what has been suspected for magnetic resonance imaging (MRI) screening, at least with regard to women at high risk for breast cancer resulting from the BRCA mutation—that MRI detects cancers of a smaller size and at an earlier stage than mammography, reported Ellen Warner, MD, of Sunnybrook Health Sciences Center, Toronto, Canada.

“We can be fairly confident that if screening with MRI finds cancers at a much earlier stage, it probably also saves lives,” she said.

The study randomized 1275 women with BRCA mutations and a 45% to 65% risk of breast cancer by age 70 into 2 annual screening cohorts—MRI plus mammography and clinical breast examination; and conventional mammography only plus clinical breast examination (control group). Both groups could receive additional testing with ultrasound or other modalities, as warranted.

Over 3 years, the incidence of invasive cancers was similar for the 2 groups, but tumors detected by MRI averaged 0.9 cm compared with 1.8 cm in the control group; tumors >2 cm constituted only 3% of MRI-detected cancers compared with 29% in the control group; and node-positive disease was presented in just 13% of the MRI-detected cancers compared with 40% in the control group. Women who underwent MRI were 3 times more likely to have stage I tumors versus more advanced tumors, and had a 73%

reduction in stage II or higher tumors, Dr Warner reported.

“These results will hopefully convince high-risk women and their healthcare providers that breast screening with yearly MRI and mammography is a reasonable alternative to surgical removal of their breasts, which is often done to prevent breast cancer,” Dr Warner said.

Alternating Mammography and Ultrasound International studies also added insights to the screening process. A large study from Taiwan showed that combining mammography and ultrasound led to a higher cancer detection rate. Chiun-Sheng Huang, MD, and colleagues studied the effect of alternating mammography with ultrasound screening among 79,691 Taiwanese women aged 40 to 49 years. The group was a young cohort who tended to have dense breasts, in which cancer can be difficult to detect on mammography, Dr Huang said.

Women were randomized into 2 study groups and 1 control group— ultrasound screening the first year and mammographic screening the second year; mammographic screening the first year and ultrasound in the second year; or no screening until the fifth year, at which time they underwent both ultrasound and mammography (control group).

The modalities were complementary (ie, together they detected significantly more cancers than mammography alone); however, in comparing one against the other, mammography was much more sensitive than ultrasound.

Mammography also detected more noninvasive and small, invasive cancers than ultrasound, and the delayed screening in the control group resulted

Antidepressant Use... Continued from page 11 pendently associated with a doubling of miscarriage risk. A higher mean dose of either drug was associated with an increased risk for miscarriage, suggesting a dose-response relationship.

However, in an accompanying commentary in the same issue, Adrienne Einarson, RN, Assistant Director of the Motherisk Program at the Hospital for Sick Children, Montreal, said that there was not a “gold standard for studying the safety of drugs during pregnancy, because all methods have strengths and limitations.” In this study, she noted, data were missing on important factors, although these results are very similar to findings

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from the Motherisk study that were published last year. Therefore, Ms Einarson notes, although no definite recommendations can be made on the risk of antidepressants in pregnancy, it does appear that there is a small increased risk for miscarriage.

The team of the new study suggests that caution is appropriate in light of these new results, and healthcare providers “who have patients of childbearing age taking antidepressants or have pregnant patients who require antidepressant therapy early in pregnancy may wish to discuss the risks and benefits with them.” ■

in more large, invasive cancers. The researchers concluded that alternating mammography and ultrasound results in greater detection, and detection of earlier-stage tumors, in young women.

“These results will hopefully convince highrisk women and their healthcare providers that breast screening with yearly MRI and mammography is a reasonable alternative to surgical removal of their breasts.”

—Ellen Warner, MD

In another study, German researchers incorporated semiannual, whole-breast ultrasound examinations into routine screening of women who were BRCA mutation carriers. Starting at age 30, the women underwent mammography plus ultrasound and MRI, with another ultrasound 6 months after initial screening.

A total of 11% of tumors were found only on semiannual ultrasound; however, investigators pointed out that the effect of this additional detection on mortality remains unknown. Coinvesti-

gator Mathias Warm, MD, said that annual mammography with ultrasound screening every 6 months is now the standard of care for women with BRCA mutations at the University of Cologne, Germany, where the study was conducted.

Earlier Screening for Minorities In a study from Birmingham, United Kingdom, investigators concluded that breast cancer screening should begin earlier for some ethnic minorities. The study included 27,444 breast cancer patients, with 528 classified as Asian, 274 as African Caribbean, and 18,941 as white. Investigators correlated patient age with mode of presentation (screening or symptoms) and ethnicity.

They found that the peak age of breast cancer incidence for Asian and black women was 10 to 20 years younger than for white women, and a large proportion presented with disease symptoms. Among the symptomatic women, 26.5% of Asians and 35% of African Caribbean women were younger than 47 years when they presented with disease, compared with 13% of the white population.

Lowering the screening age from 50 to 40 years may be the most effective means of finding cancer early in these ethnic groups, said Soni Soumian, MD, although the investigators acknowledged that this has not been shown to reduce mortality. ■

Premature Puberty in Children Linked to Estradiol Spray

By Rosemary Frei, MSc

T

he US Food and Drug Administration (FDA) issued a MedWatch Drug Safety Communication late last month regarding Evamist, an estradiol transdermal spray; this estrogen hormone therapy is used to reduce hot flashes during menopause. It is sprayed on the skin on the inside of the forearm between the elbow and the wrist.

The agency notified healthcare professionals and patients that it is reviewing reports that some children unintentionally exposed to estrogen through skin contact with Evamist have undergone premature puberty.

“Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied,” the agency warns.

“Women who cannot avoid contact

with children should wear a garment with long sleeves to cover the application site.”

According to the MedWatch item, the FDA is currently reviewing reported adverse events and is working with Ther-Rx, the product’s manufacturer, to identify factors that may contribute to unintended exposure.

The FDA will update the public when the review is complete, and it is evaluating with Ther-Rx ways to minimize the risk.

The agency is encouraging healthcare professionals and patients to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/ report.htm or 1-800-332-1088. ■

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The OB/GYN Nurse

Oncologists Try—But Fail—to Boost Mammography Rates Personal Counseling Tripled the Rate in One Study

By Caroline Helwick

S

creening mammography is credited with helping to reduce mortality from breast cancer, but most eligible women forego this test.

Screening rates are dismal, especially among certain populations, and the reasons are unclear.

Even among women with health insurance, the screening rate was only 13.4% as stated in a new study published in a journal of the American Association for Cancer Research

(Ahmed NU, et al. Randomized controlled trial of mammography intervention in insured very low-income women. Cancer Epidemiol Biomarkers Prev. 2010;19:1790-1798).

“Health insurance is a necessary condition for screening, but it is apparently not a sufficient condition,” said Nasar Ahmed, PhD, lead investigator and Chair of Epidemiology and Biostatistics at the Robert Stempel College of Public Health and Social Work at Florida

International University, Miami.

The aim of the study was to determine the best way to increase compliance among low-income women. The study found that even with health insurance, women with an annual family income of approximately $7000 were less likely to be screened than middleclass women, but a counseling program increased the chances of screening.

The investigators identified 2357 women who were noncompliant with

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mammography screening and randomly assigned them to 1 of 3 groups—(1) a control group, who had no intervention, (2) a group receiving a reminder letter from their managed care organization (MCO), and (3) a group receiving a letter from their primary physician and, if still noncompliant, counseling

Screening mammography is credited with reducing mortality from breast cancer, but most eligible women forego this test, and the reasons are unclear. from lay health workers. Although the average annual family income was $7000, all the participants had health insurance. About 50% were white, 43% were black, and 12% were Hispanic.

The screening rates were 13.4% for the control group, 16.1% for persons receiving the letter from their MCO, and 27.1% for persons who received counseling about the need for screening. A letter from the primary care physician greatly increased the likelihood of screening, and personal counseling tripled the rate. Even with this, however, screening rates remained very low, Dr Ahmed noted.

James Marshall, PhD, Professor of Oncology at Roswell Park Cancer Institute, Buffalo, NY, and an editor of the journal, commented that the study shows how low-income populations have challenges that go beyond mere finances. “A middle-class person can hop in her car and go to the clinic. How does a low-income woman find someone to watch her kids and find the transportation?” he asked.

Dr Marshall noted that programs in which lay health counselors go into area churches to reach minority, low-income women have met with some success. “A person from the community can make all the difference in the message.”

Behavioral Intervention Not Too Encouraging Results of another new study showed that no interventions are very effective in increasing mammography rates.

Although the investigators found a much higher (>70%) screening rate, they also concluded that screening rates are falling (Vernon SW, et al.

Interventions to promote repeat breast cancer screening with mammography.

J Natl Cancer Inst. 2010;102:1023-1039).

Continued on page 16

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August 2010 I Vol 2, No 4

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The OB/GYN Nurse

Bladder Cancer Update An Underrecognized Condition in Women

By Karen Roberts Reviewed by Cheryl T. Lee, MD, Dr Robert H. and Eva M. Moyad Research Professor of Urology and Director, Bladder Cancer Program, University of Michigan Comprehensive Cancer Care Center, Ann Arbor

T

ake a closer look at your patient mix—female smokers aged 50 and older, unexplained hematuria, and irritative voiding symptoms (ie, urgency, frequency, dysuria). Consider the probability that 1 in 84 adult men and women will have bladder cancer. Unlikely, you may say. Not so, according to the National Cancer Institute (NCI).1 The incidence of bladder cancer is higher than that of cervical cancer, and nearly 140,000 American women are living with bladder cancer today, according to data from the NCI.1 Given the high rate of recurrence—the highest of all malignancies2—bladder cancer is often considered a lifetime condition, making it one of the costliest cancers to treat over the lifetime of the patient.

“If we hope to reduce the number of people with bladder cancer, we need healthcare providers and consumers to know what causes bladder cancer and how it can be prevented,” said Cheryl T. Lee, MD, Director, Bladder Cancer Program, University of Michigan Comprehensive Cancer Care Center, Ann Arbor, in an interview with the OB/GYN and Infertility Nurse. “Although many people know about the association of tobacco and lung cancer, few are aware that smoking can also cause bladder cancer,” Dr Lee said.

Characteristics of Bladder Cancer • Bladder cancer is typically a transitional cell carcinoma • Symptoms include hematuria, urinary urgency, and frequency; later, urinary obstruction can cause pain; some patients present with anemia • Diagnosis is by cystoscopy and biopsy; treatment is with fulguration, intravesical instillations, surgery, chemotherapy, or a combination of these • The 3 types of bladder cancer are: • Transitional-cell carcinoma, accounting for >90% of bladder cancers • Squamous-cell carcinomas, less common and usually occurring in patients with parasitic bladder infestation or chronic mucosal irritation • Adenocarcinomas, which occur as primary tumors or may reflect metastasis from intestinal carcinoma; metastasis should be ruled out Source: Sandhu KS, et al. Obstet Gynecol Surv. 2009;64:39-49.

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A burning cigarette contains more than 4000 different chemicals. With lung cancer, one’s risk decreases when smoking is stopped. With bladder cancer, the carcinogens linger on the bladder wall even years after an individual has stopped smoking.3 Now compound that effect with occupational exposure to chemicals and toxins. The hair dresser; the factory worker in tire, paper and pulp, and textile industries; the firefighter; and the military veteran all have an increased risk for bladder cancer based on their occupational exposure to smoke, chemicals, and even arsenic-laden water sources.

Early detection is greatly hampered by a lack of awareness. Some gynecology offices are considering bladder cancer as part of the differential diagnosis for unexplained hematuria.

• 25% would repeat the urine dipstick at 3 months.

Additional individual responses included initiating therapy for overactive bladder, referral to a nephrologist, ordering a urinalysis, or taking a urine sample and doing an NMP22 BladderChek Test in the office.

The current clinical guidelines for microscopic hematuria suggest that these 2 patients should be referred to a urologist for cystoscopic evaluation.

Cystoscopic assessment by a urologist is also recommended for gross hematuria, in addition to urine cytology and upper tract imaging. Of the 75 ACOG respondents (of which 90 were board certified), only 4 indicated that they had received continuing medical education credits for reviewing the 2009 hematuria guidelines.4

“If we hope to reduce the number of people with bladder cancer, we need healthcare providers and consumers to know what causes bladder cancer and how it can be prevented.”

—Cheryl T. Lee, MD Typical Cases Presented at ACOG At the recent 2010 American College of Obstetricians and Gynecologists (ACOG) annual meeting, an on-site survey of 75 clinicians representing 28 states and 6 countries responded to questions regarding 2 typical patient scenarios.

Case 1. A 50-year-old woman who is a heavy smoker has a positive urine dipstick for microscopic hematuria. Two weeks later, a second urine dipstick is negative. Among the 75 respondents who were asked about the next step: • 30% said they would repeat the dipstick in 3 months • 30% would obtain urine cytology and renal ultrasound • 25% would refer to a urologist • 9% would order urine culture and oral antibiotics • Less than 1% would refer to a nephrologist.

Case 2. A healthy 63-year-old woman presents with gross hematuria after an exercise class. A pelvic examination is normal. She is not receiving anticoagulation therapy. Again, among the 75 respondents who were asked about the next step: • 40% said they would refer to a urologist • 25% would order oral antibiotics

Ambiguous Hematuria, Smoking, Occupational History Expeditious referral and evaluation to a urologist may change the current trend, in which women are more often than men diagnosed with bladder cancer at a later stage, which directly affects survival rates. “Among men, the incidence of myeloma, liver cancer, and cancer of the esophagus increased between 2001 and 2005, while among women, the incidence of leukemia, bladder cancer, and lung cancer has been increasing for 30 years,” according to one article.5 The Table outlines the risk factors for

Table Bladder Cancer Risk Factors Age 50+ Smoking history Occupational exposure to chemical or dyes, such as benzenes or aromatic amines History of gross hematuria Previous urologic disease, such as chronic cystitis or bacterial infections History of irritative voiding symptoms: urgency, frequency, dysuria History of pelvic irradiation Cyclophosphamide exposure

Carcinoma in situ in the bladder is a noninvasive but malignant and aggressive, flat, highgrade lesion confined to the superficial lining of the bladder.

bladder cancer. In 2006, Dr Lee and colleagues reported apparent sex and racial disparities in bladder cancer diagnosis and survival. “African Americans are diagnosed with more aggressive and more advanced tumors….African American race [is] an independent predictor for poor survival. Racial disparity continues to exist in bladder cancer presentation and survival in the US,”6 they wrote.

July 17, 2010, was the first annual National Bladder Cancer Awareness Day, representing Congress’s effort to celebrate survivors and bring awareness to this often unrecognized disease.

Nurses are urged to continue the momentum by educating patients about hematuria. Nurses dealing with women can assist in the identification of at-risk women and can help increase awareness of this cancer.

In the interview, Dr Lee noted that “as a prominent symptom of bladder cancer, hematuria is characteristically intermittent, and studies show that urologic referral of women by practitioners is sometimes delayed until ≥2 episodes of hematuria.”

Johnson and colleagues reported that a cystectomy delay of 3.1 months undermines patient survival.7 Conclusion Bladder cancer, although not a traditional “female cancer,” has a significant impact on female patients. We urge you to consider this in your patients. For more information visit www.nci.org and www.urotoday.com. ■ References 1. National Cancer Institute, Statistical Research and Applications Branch. DevCan: probability of developing or dying of cancer software, version 6.5.0. 2008. http://srab.cancer.gov/devcan.

2. Levy DA, Jones JS. Surveillance for recurrent bladder cancer. emedicine from WebMD, updated November 21, 2008. http://emedicine.medscape.com/article/458825 -overview. Accessed July 10, 2010.

3. Jemal A, Thun MJ, Ries LA, et al. Annual report to the nation on the status of cancer, 1975-2005, featuring trends in lung cancer, tobacco use, and tobacco control. J Nat Cancer Inst. 2008;100:1672-1694. Epub 2008 Nov 25.

4. Sandhu KS, LaCombe JA, Fleischmann N, et al.

Gross and microscopic hematuria: guidelines for obstetricians and gynecologists. Obstet Gynecol Surv. 2009; 64:39-49.

5. Fiore K. New cancer cases and overall disease mortality rates decline. MedPage Today. November 25, 2008. www.medpagetoday.com/HematologyOncology/Lung Cancer/11925. Accessed July 10, 2010.

6. Lee CT, Dunn RL, Williams C, Underwood W. Racial disparity in bladder cancer: trends in tumor presentation at diagnosis. J Urol. 2006;176:927-933.

7. Johnson EK, Daignault S, Zhang Y, Lee CT. Patterns of hematuria referral to urologists: does a gender disparity exist? Urology. 2008;72:498-502. Epub 2008 July 10.

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Our Commitment Continues...

CRINONE is now sold by Watson Pharmaceuticals.

Be assured that Watson supports the same product youâ&#x20AC;&#x2122;ve come to trust. And we have the same commitment to the nursing community, and all you do for your patients.

We are and will continue to be proud supporters of your efforts.

Š 2010, Watson Pharmaceuticals, Inc.

06835

Pharmacy Corner

Off-Label Use of Progestin-Based 17P for Prevention of Preterm Birth in High-Risk Women A New Drug Is Now under FDA Review

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

C

urrently used to prolong pregnancy in women with a history of preterm delivery, 17 alphahydroxyprogesterone caproate (17P) is a progestin made artificially by converting natural progesterone into a synthetic progestin. It is structurally similar to medroxyprogesterone acetate.

In 1956, Bristol-Myers Squibb’s New Drug Application (NDA) for 17P was approved by the US Food and Drug Administration (FDA), and the drug was manufactured under the trade name Delalutin. The original labeling indicated that the drug was useful in infertility with inadequate corpus luteum function, among other indications. In 2000, the FDA announced that it was withdrawing approval of the NDA for Delalutin at the request of the manufacturer, because the company was no longer marketing the drug.

The National Institute of Child Health and Human Development

Maternal-Fetal Medicine Units Network conducted a double-blind, placebo-controlled trial in 2003, involving pregnant women with a documented history of spontaneous preterm delivery.

The trial results demonstrated that weekly injections of 17P—beginning at 16 to 20 weeks gestation and continued up to delivery—substantially reduced the rate of preterm delivery before gestation week 32, 35, and 37 among women who were at high risk for preterm delivery. The likelihood of complications associated with premature birth was also reduced among infants born to women treated with 17P during pregnancy (Meis PJ, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.

N Engl J Med. 2003;348:2379-2385).

Currently, there are no FDAapproved treatments for the prevention of preterm birth. Hologic, Inc, has resubmitted an NDA to the FDA for

17P Chemical Makeup

Gestiva, the trademarked hydroxyprogesterone caproate injection 250 mg/mL. If approved by the FDA, Gestiva would become the first drug indicated for the prevention of preterm birth in women who are pregnant with a single child and have previously delivered a preterm baby.

Presently, 17P is being compounded by pharmacists and is used off-label for the prevention of preterm birth in highrisk women. The suggested dosing regimen is a 250-mg weekly intramuscular injection, beginning at 16 weeks gestation and used through 36 weeks gestation or until delivery.

Although current studies have

Presently, 17P is being compounded by pharmacists and is used off-label for the prevention of preterm birth in high-risk women. shown that 17P reduces the rate of preterm delivery, neonatal intensive care unit admission, length of stay, and associated costs, clinicians should be aware that information regarding the safety of 17P therapy to prevent preterm birth is limited. ■

The OB/GYN Nurse Aromatase Inhibitors Can Resolve Endometrial Thickness from Tamoxifen

By Caroline Helwick

W

omen with estrogen receptor–positive breast cancer are often treated with tamoxifen, which can lead to endometrial thickness, and occasionally, endometrial cancer. A study reported at the annual San Antonio Breast Cancer Symposium showed that thickened endometrium will resolve if patients switch from tamoxifen to an aromatase inhibitor.

“In asymptomatic postmenopausal patients, the switch to anastrozole after 2 to 3 years on tamoxifen leads to a clear decrease in double endometrial thickness and uterine volume compared to the patient continuing on tamoxifen,” said Johan Van Ginderachter, MD, of Maria Middelares Gent Hospital, Belgium.

This study included 72 postmenopausal asymptomatic women who developed double endometrial thickness (DET) >7 mm after 2 to 3 years of receiving tamoxifen. Patients either continued taking tamoxifen or switched to anastrozole for the remainder of the 5-year treatment, and the groups were compared.

Investigators compared transvaginal ultrasound changes for DET and uterine volume (UV) at 1 year and at the end of

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treatment with baseline measurements, and assessed menopausal symptoms.

The study was prematurely closed when aromatase inhibitors became reimbursed by the Flemish healthcare system after the announcement of a disease-free survival among patients switching from tamoxifen. At the time of closure, all patients had been followed past the 1-year visit.

Although patient groups had similar baseline endometrial thickness and UV, “clearly different changes” were observed, Dr Van Ginderachter said.

DET and UV strongly decreased for women switched to anastrozole but remained unchanged for women continuing to take tamoxifen. This difference was very significant.

Rates of withdrawal and adverse events

were not significantly different between the arms. Seven patients receiving anastrozole withdrew from the study, as did 3 patients receiving tamoxifen.

Adverse events were also similar.

Vaginal dryness increased only in the anastrozole arm. Vaginal bleeding was reported in 3 patients who were receiving tamoxifen and in 2 patients who were receiving anastrozole. ■

Oncologists Try... Continued from page 13 This study was a methodologically rigorous review of the literature on controlled behavioral interventions aimed at increasing repeat mammography screening among women at average risk for breast cancer. The study found that after peaking at 70.1% in 2000, screening rates fell to 66.4% in 2005. Reasons may include lack of insurance access, higher copays, and confusion over what mammography can and cannot do in preventing breast cancer, Vernon and colleagues concluded.

“Their results are sobering,” wrote the authors of an accompanying editorial (Mandelblatt J, et al. The elusive goal of maintaining population cancer screening: it is time for a new paradigm.

J Natl Cancer Inst. 2010;102:998-999).

They added that behavioral interventions increase the rates by only a smallto-moderate amount, “and there is insufficient evidence to know which approaches are the most effective.”

“These results are all the more discouraging because the reviewed studies focused on getting women to undergo only 1 to 2 repeat screening examinations and not the 12 to 13 biennial screenings presently recommended for average-risk women aged 50 to 74 years,” the editorialists wrote.

“Even intensive counseling approaches, which included patient navigation, showed only a modest return for their high resource intensity. The most effective approaches…appear to be

reminder systems,” although the variability among those studies made it hard to draw conclusions, they added.

Lead editorialist, Jeanne Mandelblatt, MD, MPH, of Georgetown University’s Cancer Control Program in Washington, DC, suggested that changing any behavior is difficult, and asking healthy people without symptoms to have a test is even harder. She added that some women may just be “making an informed choice to not use an imperfect technology.”

If that is the case, time and money may be better spent discovering better early-detection tests “rather than continuing to invest in getting a few more women to regularly use a flawed technology,” Dr Mandelblatt said. ■

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ACOG Highlights

Preterm Birth Update

See also pages 18, 20

58TH ANNUAL CLINICAL MEETING

By Jessica A. Smith

T

he past 2 decades have seen an increase in preterm births (PTBs), particularly in the United States. Each year, more than 500,000 American babies are born preterm, with medically indicated PTB accounting for 33% of that number, said Rita W. Driggers, MD, Director of the Maternal-Fetal Medicine Fellowship Program at Washington Hospital Center and Associate Professor, Department of Obstetrics and Gynecology, Georgetown University School of Medicine, Washington, DC, during her presentation at the 2010 annual meeting of the American Congress of Obstetricians and Gynecologists (ACOG).

Defined as birth before 32 weeks gestation, PTB is not significantly prevalent in any one ethnicity—18.3% in blacks, 12.1% in Hispanics, and 11.6% in whites.

Its impact can be devastating. Of all babies born preterm, 20% die within the first year of life. Although PTBs comprise only 2% of all US births, they account for >50% of infant deaths.

Long-term disabilities in infants born preterm include cerebral palsy, mental retardation, respiratory problems, and hearing and visual impairment.

The financial effects of PTB are staggering as well. The annual costs associated with PTB in the United States total >$26 billion. The average firstyear medical expenses for a full-term infant are $3325 compared with $32,325 for a preterm infant.

Predicting PTB The key to preventing PTB is early identification of women at risk, Dr Driggers said. Risk factors include: • Previous PTB—risk increases with the number of PTBs • Multiple gestation—mean duration of pregnancy is 35 weeks for twins, 32 weeks for triplets, and 29 weeks for quadruplets • Short cervix—predictive value influenced by estimated gestational age • Uterine infection—more likely with earlier-onset PTB • Previous cervical surgery • Smoking • Illicit drug use • Low prepregnancy weight • Poor nutritional status • Short interval between pregnancies (<6 months).

Biomarkers for PTB can be measured by amniotic fluid; urine; cervical and vaginal secretions; blood; or saliva.

However, no one biomarker is effective for predicting PTB in all women.

Salivary estriol level testing can be helpful in predicting late PTB, but is

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not useful in identifying women at risk for early PTB. Although bacterial vaginosis is an independent risk factor for PTB, there are insufficient data to indicate a PTB reduction benefit from screening and treating for bacterial vaginosis, Dr Driggers said.

Fetal fibronectin (fFN) testing has a negative predictive value, which is useful in avoiding unnecessary interventions (Table 1). An adhesive between the chorion and decidua, fFN can serve as a marker for disruption of the chorioamnion and underlying decidua.

Although fFN normally shows up in cervicovaginal secretions until 16 to 20 weeks of gestation and again during the third trimester, Dr Driggers said, testing for its presence between those times can be valuable. Avoid testing in women who are asymptomatic or at low risk of PTB, she added.

The predictive value of negative fFN test results for delivering before 37 weeks ranges from 69% to 92%; the negative predictive value for ruling out delivery within the next 2 weeks is >95%.

Measuring cervical length is another valuable tool in assessing the risk for PTB (Table 2). According to Dr Driggers, there is a continuous association between cervical length and PTB—the shorter the cervix, the higher the risk for PTB. The test should be conducted between 14 and 30 weeks gestation, when a normal cervical length ranges between 25 mm and 50 mm. “The nice thing about this is, it can be used on anyone,” she said.

Preventing PTB A number of other factors can cause PTB. Infection or inflammation, physical or psychological stress, abnormal uterine bleeding, stretching of the uterus, and genetics can all contribute to PTB, Dr Driggers noted. Heredity can often play a part when a woman has had a previous PTB or the woman was

born preterm; paternal genes are not known to have an effect on PTB. Several interventions aimed at preventing PTB have been shown to be of little to no help, with some even carrying deleterious effects, Dr Driggers said.

Bed rest, although widely prescribed by OB/GYNs, has not proved effective in preventing PTB; it has shown evidence of harmful effects, including stress, weight loss, and depression. “The truth is, it does not affect preterm labor,” Dr Driggers said.

Although hydration has been thought to reduce uterine contractility by bringing more blood to the uterus and by decreasing pituitary secretion of antidiuretic hormone and oxytocin, there are insufficient data to support it as a preventive measure for PTB. Home uterine activity monitoring involves the use of a tocodynamometer, which records and relays daily uterine activity to a patient’s practitioner. The method is approved by the US Food and Drug Administration for use in women with a previous PTB, but it has not shown benefit in preventing PTB, and is not recommended by ACOG. Progesterone is one intervention that has proved helpful in preventing PTB. Progesterone supplements should be given to women with singleton pregnancy and previous PTB caused by preterm premature rupture of membranes or preterm labor. Its use should also be considered for asymptomatic women with cervical length <15 mm, she said.

Cervical cerclage—a surgical procedure to stitch the cervix closed during pregnancy—is another option for PTB Table 2 Measuring Cervical Length

Table 1 Fetal Fibronectin Specimen Collection

Use transvaginal ultrasound Patient’s bladder must be empty Use minimal pressure Visualize entire cervix Measure from internal to external cervical opening Measure over 5 min Record shortest cervical length

Collect specimen during speculum examination, before digital examination or manipulation of cervix Lightly rotate swab across posterior fornix for 10 sec Place swab in collection tube, immersing tip in buffer Break shaft of swab, insert into tube, cap tightly, label, and send

Possible Problems Bladder not empty Too much pressure used Failure to visualize entire cervix Incorrect caliper placement Contraction Underdeveloped lower uterine segment

Source: Rita Driggers, MD. Preterm birth: best practices for the obstetrician. Presented at 2010 annual meeting of the American Congress of Obstetricians and Gynecologists, San Francisco, CA; May 17, 2010.

Source: Rita Driggers, MD. Preterm birth: best practices for the obstetrician. Presented at 2010 annual meeting of the American Congress of Obstetricians and Gynecologists, San Francisco, CA; May 17, 2010.

THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS

prevention. “Elective cerclage at 13 to 16 weeks should be offered for patients with 3 or more unexplained second trimester losses or PTBs,” Dr Driggers said. Cerclage should also be considered for patients determined to be at risk for PTB with cervical length <15 mm to 25 mm.

Drug Therapy Antibiotics. “The good news is 80% of women who present with preterm labor will deliver at term,” Dr Driggers said. In addition, she noted that treating for PTB can help. Although antibiotics should not be used for the sole purpose of preventing PTB, antibiotic therapy is in order if a culture test is positive.

Group B streptococcus, which can be passed to the infant during delivery, should be treated according to the Centers for Disease Control and Prevention’s guidelines, which call for penicillin G (5 million units for the first dose and 2.5 million units every 4 hours until delivery, administered intravenously), or alternately, ampicillin (2 g for first dose and 1 g every 4 hours intravenously until delivery).

Corticosteroids are the most effective intervention for PTB, decreasing the incidence of respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and mortality (with betamethasone only) in preterm infants, Dr Driggers explained. Candidates for a single corticosteroid include all women between 24 and 34 weeks gestation who are at risk of PTB within 7 days. Repeat courses of corticosteroids, however, should only be used in women enrolled in clinical trials, she noted.

Tocolytic drugs can be useful in prolonging gestation 2 to 7 days; however, the benefits of delaying labor for such a period only appear applicable when a course of corticosteroids is needed or for the sake of geographical transport of the woman to where she is to give birth, Dr Driggers said. It is important to consider the health status of the mother and fetus when considering tocolysis. “Many times, people are in preterm labor because the baby needs to come out,” she explained.

The choice of tocolytic agents should be individually catered to a patient’s needs, and factors such as contraindications, drug side effects, and gestational age should be taken into account. For women presenting with preterm labor before 28 weeks gestation, magnesium sulfate can be useful to reduce cerebral palsy risk for the infant. ■

August 2010 I Vol 2, No 4

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ACOG Highlights

The Looming Shortage of OB/GYNs Potential New Opportunities for Nurse Practitioners

Upcoming Meetings

By Jessica A. Smith

A

perfect storm is brewing in the area of OB/GYN, likely to create a shortage of OB/GYN practitioners in its wake, suggested experts during the 2010 annual meeting of the American Congress of Obstetricians and Gynecologists (ACOG) at a session titled, “The Future OB/GYN Workforce: Will We Have the Right Number, Distribution, and Skills?”

The demand for physicians in the coming years is projected to exceed the supply, and this challenge will also be faced by OB/GYNs, said Edward Salsberg, Director, Center for Workforce Studies, Association of American Medical Colleges, Washington, DC. A major contributor to this much-anticipated storm is the increasing demand for physicians. “There is a gale force wind on the demand side,” Mr Salsberg said.

The most obvious factor leading to the increase in demand comes from the continuing growth of the US population—about 25 million people per decade. The aging US population is another factor: the number of citizens aged >65 years is slated to double between 2000 and 2030, and many baby boomers will be reaching age 65 next year, Mr Salsberg added. The increase in older individuals translates to a rise in chronic illnesses, resulting in more visits to physicians overall. In addition, physician office visits by those aged >45 years continue to increase, he said.

Improved survival rates, and the impact of decades of increasing obesity rates and poor lifestyle, will also help fuel the physician shortage, along with the need for addressing existing disparities in care.

Healthcare Reform Healthcare reform will also play a huge role in demand, with 30 million new patients being added to the system, said William Rayburn, MD, MBA, Seligman Professor and Chair, Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque. “As our population gets older and with increasing patients from healthcare reform….

OB/GYNs are going to have to do more primary care, whether we want to or not, because it’s needed,” Dr Rayburn noted.

Healthcare reform brings both good and bad news for OB/GYNs, according to Mr Salsberg. The good news is that the principles of healthcare reform align themselves nicely with those that are important to OB/GYN—access, continuity, collaborative practice, and bundled payments. The bad news is that healthcare reform provides extensive

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support for primary care, but OB/GYN is not considered primary care.

Regarding the care being provided, there is some “schizophrenia or confusion” within the field, said Erin Tracy, MD, MPH, Assistant Professor, Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Massachusetts General Hospital, Boston. A survey of 139 OB/GYNs revealed that 64% do not wish to provide primary care in their practices, whereas 62% feel they already provide primary care, she said.

“OB/GYNs are going to have to do more primary care, whether we want to or not.”

—William Rayburn, MD, MBA

In response to Mr Salsberg’s question whether OB/GYNs should “jump on the bandwagon” of the reform-born patientcentered medical home, Douglas Laube, MD, MEd, Professor, Obstetrics and Gynecology, University of WisconsinMadison, said he sees a place for OB/GYNs in the medical home. “I hope we can at least rent a room in the home and carve a place for ourselves in…primary care,” Dr Laube said.

The Aging of OB/GYNs There is “no rescue in sight on the supply side,” Mr Salsberg said. Baby boomers reaching retirement age will also have an impact on practitioners; he predicted that retirement among physicians will spike over the next 3 to 5 years, because many put it off as a result of the depressed economy.

In addition, 39% of all active OB/GYNs are older than 55 years.

Although the number of OB/GYNs entering the workforce is growing slowly but steadily, the number reaching retirement age is about the same. Also, he said “there is some frustration” among OB/GYNs in general, which may lead to early retirement.

The Gender Gap Gender also comes into play. The predominance of women OB/GYNs is significant from a workforce planning perspective, because male physicians work longer hours than females, and both sexes work fewer hours after reaching age 65. Among physicians of

both sexes who have children younger than 5 years, males work more hours than their female counterparts, Mr Salsberg said.

“Female physicians do twice as much work at home,” compared with their male counterparts, Dr Tracy said, attributing the discrepancy to cultural expectations of women. She added that 20% of OB/GYNs have worked parttime at some point in their careers, and data have shown that part-time physicians are more productive. Overall in the United States, 8% of men and 21% of women work part-time. “If you are looking to hire a female partner, you cannot assume she wants to work parttime,” she pointed out.

In addition, the number of American women is projected to increase by 15% between 2010 and 2025, with the number of childbearing-aged women expected to grow by 10% during that time, which will also have an impact on the OB/GYN profession, Mr Salsberg said.

“We’re going to have a shift of more women ACOG fellows taking over the workforce,” Dr Rayburn said, citing the 10-year age differential between men and women gynecologists. The average age of a male ACOG fellow is 54 years, and the average age of a female OB/GYN is 45 years.

Weathering the Storm In light of these projections, the question of what will happen in the event of an OB/GYN shortage looms large. “Our system responds to shortages,” Mr Salsberg said.

On the supply, or practitioner, end of the equation, a shortage would bring the following changes: • Practitioners work longer hours • Increased use of nurse practitioners and other support staff • Extended time between visits • More phone/e-mail contact with patients (if reimbursed?)

• Innovations.

On the demand, or consumer, side, changes would include: • Longer waits for appointments • Increased emergency department use • Traveling farther for care • Seeing different types of providers • Some patients do not get necessary care.

How things play out will depend largely on how OB/GYNs respond to the predicted shortage. “How can we use teams better? How can we delegate better? Regardless of the number of physicians, how we use those physicians determines a lot,” Mr Salsberg said.

“These changes are a challenge, but really an opportunity.” ■

SEPTEMBER Birth Institute and American Association of Birth Centers (AABC) 9/2-9/4 Newport Beach, CA Contact: (866) 542-4784 or (215) 234-8068 www.birthcenters.org

2010 South Dakota Perinatal Association Conference 9/9-9/10 Pierre, SD Contact: Kris Mark, Executive Director (605) 333-5210, markk@sanfordhealth.org www.sdperinatal.org

Ultrasound Update 2010 9/11-9/12 Sacramento, CA Contact: (916) 734-5390 www.ucdmc.ucdavis.edu/cme/conferences/

2010 International Nursing Conference on Reproductive Health and Infertility 9/15-9/17 Tampa, FL Contact: Condor Registration Services (256) 852-4490 www.reinursingconf.com

Reproductive Health 2010 9/22-9/25 Atlanta, GA Contact: (202) 466-3825 www.arhp.org

Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) 9/25-9/29 Las Vegas, NV Contact: (301) 694-5243 or (866) 229-2386 www.awhonn.org

2010 American Urogynecologic Society (AUGS) 9/29-10/2 Long Beach, CA Contact: (202) 367-1173 www.augs.org

OCTOBER North American Menopause Society (NAMS) 10/6-10/9 Chicago, IL Contact: (440) 442-7550 www.menopause.org

International Center for Traditional Childbearing (ICTC) 10/7-10/10 Long Beach, CA Contact: (503) 460-9324 www.ictcmidwives.org

Society of Urologic Nurses and Associates (SUNA) 10/8-10/11 Boston, MA Contact: (888) 827-7862 www.suna.org

Nurse Practitioners in Women’s Health (NPWH) 10/13-10/16 Palm Desert, CA Contact: (202) 543-9693, ext. 4 www.npwh.org

Midwives Alliance of North America (MANA) 2010 10/14-10/17 Franklin, TN Contact: (888) 923-MANA http://mana.org

American Society for Reproductive Medicine (ASRM) 10/23-10/27 Denver, CO Contact: (866) 471-7224 or (703) 449-6418 www.asrm.org

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Clinical News Continued from page 5

first FDA-approved treatment for women with reduced sexual desire. The FDA has yet to render its final decision, but experience has shown it usually follows the Advisory Committee’s recommendations. If the FDA heeds the committee’s advice, flibanserin will join the ranks of other unsuccessful attempts at addressing HSDD in women, including sildenafil (Viagra) and some hormonal treatments.

physician, or at home. The researchers found that the vast majority of women (75.7%) chose to take the test at home compared with only 16.1% who prefered to be screened in the clinic and 8.2% who would rather be screened by a physician.

STI screening was completed by 228 women, 64.6% of whom had done home-based testing. Black women were the one ethnic group more likely to choose clinic or physician testing

(42%) rather than home testing (28%). There were no other differences in demographic characteristics, STI risk factors, or access to healthcare among the groups.

Having More Children Linked to Untreated Cavities The more children a woman has, the more untreated cavities she is likely to have in her mouth, a new study has shown (Russell SL, et al. Parity & untreat-

ed dental caries in US women. J Dent Res. 2010 Jul 14. Epub ahead of print).

Investigators suggest that this is part of the picture of pregnant women and dentists not focusing enough on the mother’s health.

“A lot of dentists are hesitant to treat pregnant women; they’re afraid of litigation, they’re afraid it’s not safe,” said lead investigator Stefanie Russell, DDS, PhD, MPH, of New York University.

Continued on page 20

College Women More Adherent to Contraceptive Ring than the Pill College and graduate female students reported better adherence to the use of the contraceptive vaginal ring compared with an oral contraceptive (OC) in a randomized, controlled trial that compared satisfaction with and adherence to the 2 methods (Gillian ML, et al. Adherence and acceptability of the contraceptive ring compared with the pill among students. Obstet Gynecol.

2010;115:503-510).

Researchers randomized 273 female college students, aged 20 to 24 years, to the contraceptive vaginal ring or OCs for 3 consecutive menstrual cycles.

Using daily online diaries, participants reported on adherence and satisfaction with their respective methods; after 3 months, they were given an online survey to gauge their plans to continue their given method, as well as their overall satisfaction with it; and after 6 months, participants were surveyed to find out if they had continued to use contraception, and if so, which method they chose.

Overall, contraceptive ring users reported greater adherence to their method compared with OC users, although adherence levels flagged with each passing month (first month, 82% vs 70%; second month, 76% vs 64%; third month, 66% vs 65%). Despite approximately 50% of each group reporting plans to continue their given method after the 3-month study period, close to 50% of both groups reported using condoms or no contraception at the 6-month follow-up.

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August 2010 I Vol 2, No 4

19

ACOG Highlights

New Findings Featured at ACOG

Clinical News...

By Jessica A. Smith

“They may not be aware of the clinicalpractice guidelines that show it’s safe to treat pregnant women.”

Dr Russell and colleagues delved into data from 2635 women in the Third National Health and Nutrition Examination Survey conducted between 1988 and 1994. They found that an average of 21.7% of the teeth of women who had ≥4 children had untreated cavities compared with 6.1% of the teeth of women with fewer children. This relationship held true in women of all socioeconomic strata, although the problem was more acute in women of lower socioeconomic status.

The team performed other analyses to try to explain this relationship but were unable to do so. They believe it is likely a combination of biologic and behavioral factors, but they note that more research is needed to better understand this association and to show how the problem could be overcome.

The following summaries represent some of the relevant findings from studies presented during the poster sessions at the 2010 annual meeting of the American Congress of Obstetricians and Gynecologists (ACOG).

High Success Rate with Vaginal Birth after Cesarean High success rates and minimal complications make vaginal birth after cesarean (VBAC) delivery a sound option for patients who have received appropriate counseling, particularly for women who present with spontaneous labor before 41 weeks of gestation or have had a previous vaginal delivery, according to the results of a new study presented at the meeting.

The investigators examined outcomes in 1035 women who had had a VBAC between 2004 and 2008 (84.4% Hispanic; 6.3% African American; 4.3% Caucasian; and 5.0% other ethnicity). Of these women, 84% (n = 869) had a successful VBAC. In addition, of the 577 women who had a previous successful vaginal delivery, 93% (n = 536) had a successful VBAC. No fetal, neonatal, or maternal deaths were reported in any of the study participants and no cesarean hysterectomies were performed.

Many Women Unaware of Emergency Contraception Greater educational outreach is needed to spread awareness of emergency contraception among women wishing to prevent pregnancy, according to study results presented at the meeting. The investigators identified many women presenting to an abortion clinic in Charleston, SC, who were unaware of emergency contraception availability.

For the study, 623 women completed an emergency contraception awareness survey. Lack of awareness of overthe-counter emergency contraception was reported by 31.7% of participants.

Risk factors for being unaware of emergency contraception included: • Black race • Lower educational level • Nonuse of contraception • Increasing parity.

In women aware of emergency contraception, 5.3% reported using it during their current pregnancy and 21% reported past emergency contraception use. Women who were aware of this contraceptive method had a higher likelihood of using it in the future (88% vs 82%).

Among women aware of emergency contraception but not using it, the fol-

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August 2010 I Vol 2, No 4

lowing reasons were cited for nonuse: • “Taking a chance,” 24.1% • Contraception failure, 20.1% • Inability to obtain emergency contraception within 3 days, 18.6% • Financial reasons, 2.4% • Ignorance of emergency contraception being available over the counter, 4.7% • Pharmacy unavailability, 0.7% • Other reasons, 2.6%.

OB/GYN Residents Ignorant about Female Sexual Dysfunction A majority of third- and fourthyear OB/GYN residents have subpar comprehension and confidence for treating problems with female sexual dysfunction (FSD), according to survey results discussed at ACOG. This internet-based survey queried 234 residents, of which 91.5% reported having attended ≤5 educational activities on FSD; 19.6% reported always or often screening for FSD, and the majority had little to no knowledge about FSD screening questionnaires.

In addition, 82.8% stated they were confident in their ability to obtain a complete sexual history but only 54.7% felt equipped to conduct a targeted physical examination.

More than half (55.1%) of respondents had treated women with dyspareunia (pain during intercourse); 18.4% treated women for low sexual desire; 16.7% treated vaginismus; 8.1% treated arousal problems; and 5.6% treated anorgasmia.

Moreover, 34% to 56% reported rarely or never recommending counseling or medications as ancillary therapy for FSD. Nearly all the residents responded that their confidence level with FSD would increase with further education, such as lectures, 97.9%; patient observation, 97.4%; rotations with a urogynecologist, 94.4%; and online modules, 90.6%.

New OC Effective for Menstrual Bleeding Problems In women with heavy and/or prolonged menstrual bleeding who have no organic pathology, the oral contraceptive (OC) estradiol valerate/ dienogest (E2V/DNG) has been shown to be very effective treatment, researchers reported at the meeting.

58TH ANNUAL CLINICAL MEETING

THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS

The new OC, marketed under that trade name Natazia, received US Food and Drug Administration (FDA) approval in May 2010. It is not currently FDA approved for treating menstrual bleeding problems.

This study was a pooled analysis of 2 multicenter, double-blind, randomized, placebo-controlled trials with identical design. One study was conducted in the United States and Canada, and the other in Europe and Australia.

The women were randomized to E2V/DNG or to placebo for 196 days.

Of those who completed the study, 193 were randomized to E2V/DNG and 113 to placebo. In the E2V/DNG group, 42.0% were considered complete responders compared with 2.7% in the placebo group.

During 90 days of observation, a significantly greater mean reduction in menstrual blood loss was observed in the E2V/DNG group (–414 mL ± 373 mL) compared with the placebo group (–109 mL ± 300 mL).

Daily Messages Don’t Improve Adherence to OCs Using daily text messages as a reminder for women to take their OCs proved unsuccessful in a randomized, controlled trial. The study tracked OC adherence among new users for 3 months, with the use of an electronic monitoring device. Among 73 women who completed the study, there was no significant difference in the mean number of missed pills between women randomized to text messaging (4.1 ± 2.6) and those in the control group (3.7 ± 3.4).

The researchers noted that the nonsignificant difference may be a result of the use of other reminder systems among the control group, but pointed out that the number of missed pills was high for the entire study population. ■

For more ACOG highlights, see pages 17 & 18

Continued from page 19

Pregnancy Increases Male Partner’s Risk for Contracting HIV from the Woman Previous research has established women’s increased risk of contracting HIV during pregnancy, but until the presentation of a new study at the 2010 International Microbicides Conference (Pittsburgh, PA), no association was established between HIV-positive pregnant women and their male partner’s risk for HIV infection. This study was the first to examine the effects of pregnancy on the risk of men becoming infected with HIV from their female partners, showing that pregnancy increases not only the woman’s risk for contracting HIV infection but also increases her male partner’s risk by 2fold. That is, a man who is in sexual contact with an HIV-positive woman who is pregnant is at 2-fold increased risk for becoming infected with HIV than if the woman is not pregnant.

“This is the first study to show that pregnancy increased the risk of femaleto-male HIV-1 transmission,” the researchers wrote.

This 24-month study included 3321 serodiscordant couples from 7 African countries; the male partner was HIVpositive in 1085 (32.7%) of the couples, and the female partner was HIV-positive in 2236 (67.3%) of the couples.

Overall, there were 823 pregnancies among enrolled couples, with 503 women with HIV-1 and 320 women not infected with HIV. Pregnancy in female partners with HIV-1 was associated with an increased female-to-male transmission risk. The heightened risk held true after adjusting for sexual behavior and other potentially confounding factors. ■

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The Infertility Nurse

Legal Matters: Infertility Cases from Around the Globe Melissa B. Brisman, Esq, and Lauren Murray, Esq Ms Brisman is the owner of Melissa B. Brisman, Esq, LLC, Reproductive Possibilities, LLC, and Surrogate Fund Management, LLC. Ms Murray is an associate at Melissa B. Brisman, Esq, LLC.

I

n our previous article we focused entirely on legal issues related to infertility events happening here in the United States. This month we look at legal issues of infertility unfolding in the Middle East, India, and Canada.

Although they all bear resemblance to infertility issues occurring in the United States, the legal aspects of these cases are unique to each country, affecting infertility issues in unique ways.

DNA Results End an Infertile Couple’s Dream of Parenthood Recently, a Canadian couple tried to return to Canada after traveling to India to pick up their new twin babies born to an Indian surrogate mother.

The couple, both doctors, had contracted with a woman in India to carry children conceived from the couple’s own ova and sperm. To obtain travel documents for the twin children, the Canadian couple visited the Canadian High Commission in India. Medical officials back in Canada urged the Canadian High Commission to “fasttrack” the paperwork so that the new parents and children could return home quickly.

Against the wishes of those medical officials and the new parents, the Canadian High Commission ordered DNA tests. Surprisingly, the DNA test results showed that the twin babies were not related either to the Canadian couple or to the Indian carrier. There is no further information available at this time about how this mistake occurred, or about the identity of the twin babies’ genetic parents. The Canadian couple left India without the babies, who may end up spending their childhood in an Indian orphanage.1 Surrogacy Obstacles for Homosexuals Homosexual individuals and couples living in Israel are increasingly entering into surrogacy arrangements with surrogates outside their country in the attempt to build their families.

Currently, these intended parents look primarily to India and the United States for their surrogates. In response to this trend, the Israeli Interior Ministry has issued a set of guidelines establishing a process by which these new parents can reenter Israel with their newborn children.

In the case of same-sex male couples, these guidelines allow the biological father to be declared the legal parent

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and the other partner, the nonbiological parent, to complete an adoption in Israel to be recognized as a legal parent.

A DNA test must be completed on the baby before reentering Israel. In the United States, no court order is necessary to have the DNA test administered. In India, however, an Israeli court order is necessary for the DNA test to be performed, causing many children and their new parents to remain stuck in India for a period of time after birth.

An Israeli named Dan Goldberg was living in Mumbai while waiting for DNA results for his twin sons, Itai and Liron, who were born to an Indian surrogate in March 2010. The necessary DNA testing was delayed, which prevented Mr Goldberg from obtaining

Surprisingly, the DNA test results showed that the twin babies were not related either to the Canadian couple or to the Indian carrier. health insurance for the children or returning with them to Israel. In an interview with an Israeli newspaper, Mr Goldberg expressed concern that he had not been able to have the children vaccinated and, without insurance, could not afford the cost of regular medical check-ups for the newborns.2 Moreover, his extended and unanticipated stay in India had depleted his savings and left him ask-

ing strangers for financial assistance. Over the course of 4 years, including 2 failed in vitro fertilization procedures, he had spent more than $45,000 in an effort to create Melissa B. Brisman, Esq Lauren Murray, Esq his family.2 Mr Goldberg was one of several ples were informed by the Assuta homosexual couples and individuals Medical Center in Tel Aviv that a who have experienced difficulty in power outage at the facility resulted receiving cooperation from the Israeli in damage to the couples’ fertilized Family Court in Jerusalem. Several men eggs. The damage was severe enough filed separate appeals after Family Court that the fertilized eggs could not be Judge Philip Marcus refused to issue used. The power failure was caused by orders for DNA testing. Judge Marcus an independent electrical engineer stated that he lacked the authority to who was conducting a test of the issue such orders.2 In Mr Goldberg’s facility’s power system. It occurred at case, he filed an appeal with the Assuta Medical Center’s campus in Jerusalem District Court. The District Ramat Hachayal, which was opened a Court agreed that Judge Marcus had year ago and is considered by many to authority to issue an order for a paterni- be the most luxurious private hospital ty test, appointed a guardian for the in Israel.4 twin babies, and referred the case back to Judge Marcus. Judge Marcus then Tax Credit for Infertility Treatment Finally, this month’s legal update asked the Jerusalem District Attorney’s Office for its opinion as to whether any ends with some good news for infertile legal obstacles existed that would pre- couples living in the province of vent him signing an order initiating Manitoba, Canada. Effective October 1, DNA testing. The District Attorney’s 2010, the government in the province Office replied that no legal obstacles is offering a 40% tax credit for eligible existed. Judge Marcus relented, and, fertility treatments that cost up to after several months of waiting, Mr $20,000 annually, or a maximum annuGoldberg was able to return home to al credit of $8000 per couple. Combined with previously existing tax credIsrael with his twins.3 its, couples in Manitoba could have up Power Outage Destroys to two thirds of their fertility treatment Fertilized Eggs expenses reimbursed.5 ■ In another story from Israel, 9 couReferences 1. Westhead R. Troubling questions surround surrogateborn children in India. Toronto Star. April 26, 2010. www.thestar.com/news/world/article/800791--troublingquestions-surround-surrogate-born-children-inindia?bn=1. Accessed May 15, 2010.

2. Zarchin T. Gay father of twins born to Indian surrogate denied permission to bring his sons home.

Haaretz.com. September 5, 2010. www.haaretz.com/ print-edition/news/gay-father-of-twins-born-to-indiansurrogate-denied-permission-to-bring-his-sons-home1.289128. Accessed May 15, 2010.

3. Zarchin T. Surrogate twins’ father gets go-ahead for paternity test. Haaretz.com. May 18, 2010. www. haaretz.com/print-edition/news/surrogate-twins-fathergets-go-ahead-for-paternity-test-1.290878. Accessed May 25, 2010.

4. Even D. Power outage at Tel Aviv hospital’s IVF lab damages fertilized eggs. Haaretz.com. May 13, 2010. www.haaretz.com/misc/article-print-page/power-out age-at-tel-aviv-hospital-s-ivf-lab-damages-fertilizedeggs-1.290052?trailingPath=2.169%2C2.225%2C2.

226%2C. Accessed May 25, 2010.

5. Kusch L. Province to give tax credits for fertility treatments. Winnipeg Free Press. May 18, 2010. www. winnipegfreepress.com/local/province-to-give-taxcredits-for-fertility-treatments-94059194.html.

Accessed May 25, 2010.

August 2010 I Vol 2, No 4

21

The Infertility Nurse

Hyperprolactinemia and Fertility Edward L. Marut, MD Medical Director, Fertility Centers of Illinois, Highland Park IVF Center

H

yperprolactinemia is a relatively common cause of menstrual abnormalities and infertility. It may be accompanied by galactorrhea, a milky or watery nipple discharge, either spontaneously present or easily expressed. Blood for a prolactin level should be drawn, along with a thyroid-stimulating hormone (TSH) level, in any patient with ovulatory or menstrual disturbances, or nonpuerperal galactorrhea.

The Causes of Elevated Prolactin Levels Prolactin causes lactation by a direct mammary action and disrupts ovulation through its suppression of gonadotropinreleasing hormone (GnRH) levels. The physiologic effects of nursing in causing postpartum amenorrhea are well recognized. The normal ranges of prolactin may differ by different laboratories, but not by much. The upper limit of normal is about 30 ng/mL. To assess prolactin levels, blood should be drawn in a fasting state in the morning to avoid spurious elevations from food intake or time of day. In addition, if the patient is having menstrual cycles, the test should be done within a few days of the period, because cycledependent elevations also occur.

The sample should be drawn after the patient has been at rest for at least 15 minutes and before any other procedures, because stress often readily elevates prolactin to significantly high levels. Although the concern for the source of hyperprolactinemia lies in the presence of a pituitary tumor, there are several other medical conditions that result in high levels of prolactin.

Drug effects. The use of psychoactive drugs, especially antipsychotics and antidepressants, can elevate prolactin levels. Metoclopramide (Reglan) is used in gastrointestinal disorders and raises prolactin levels. Other antihypertensives, antibiotics, and hormonal preparations may have similar effects and should be ruled out as the cause.

The control of prolactin secretion, which is pulsatile, is tonic inhibition by the neurotransmitter dopamine, and many of these drugs work by interfering with the dopamine effect. The prolactin levels are usually not in the range of those produced by a prolactinoma and treatment is problematic, because the beneficial effects of the offending medication can be reversed by treatment of the elevated prolactin.

Hypothyroidism. Primary hypothyroidism also can result in hyperpro-

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August 2010 I Vol 2, No 4

lactinemia. Low thyroid hormone production by the thyroid gland results in the typical elevation of TSH, which is stimulated by negative feedback on the hypothalamic thyrotropin-releasing factor (TRF). TRF also stimulates prolactin release from the pituitary gland, by a direct effect on prolactin-secreting cells or by reducing dopamine effect.

Treatment of the thyroid deficiency should normalize the prolactin level.

Breast stimulation. Local breast stimulation, including voluntary stimulation, can also elevate prolactin levels, as well as stimulation of the chest wall lesions, including tumors or inflammatory processes (eg, zoster infection), that stimulate thoracic nerves. Vasoactive intestinal peptide is the likely cause for the prolactin effects associated with breast stimulation.

Other medical conditions. Chronic or acute liver and renal disease can be associated with hyperprolactinemia, because of the impaired clearance from the bloodstream. Chronic or acute stress states will elevate prolactin to moderately high levels, which will often normalize with repeated measurements under less stressful conditions.

Macroprolactinemia is an unusual cause of hyperprolactinemia, and has no pathologic effects; it is a result of polymerization of smaller molecules of prolactin and failure to bind to its receptors.

Prolactinomas If prolactin levels exceed 100 ng/mL, there is cause for suspicion of a prolactinoma, which is best diagnosed by magnetic resonance imaging. If a microprolactinoma or microadenoma (<10 mm) is present, further assessment is usually not necessary. A macroprolactinoma or macroadenoma (â&#x2030;Ľ10 mm) calls for ophthalmologic consultation (for visual field testing) or neurosurgical consultation (if neurologic symptoms are present), although surgery is rarely indicated, except in extreme cases.

A prolactin level >250 ng/mL suggests a macroadenoma. The likelihood of a microadenoma is small with moderately elevated prolactin levels, but a tumor can be associated with any elevation, and it never hurts to document the pituitary gland anatomy, to have a baseline measurement.

Medical Treatment The treatment of hyperprolactinemia depends on the degree of prolactin elevation, the associated symptoms, and the fertility wishes of the patient. A woman with normal menses but annoy-

ing galactorrhea would be a candidate for pharmacotherapy, as would a woman with hypoestrogenic amenorrhea, or a woman attempting pregnancy.

The hypogonadotropism induced by hyperprolactinemia can lead to osteoporosis, among other complications of hypoestrogenism; however, relatively mild elevations in prolactin levels, even in the presence of a microadenoma, can be followed expectantly. Menstrual irregularity can be safely treated with hormonal contraceptives, which usually do not affect the levels adversely.

Dopamine agonists. The mainstay of medical treatment is bromocriptine (Parlodel), a dopamine agonist that stimulates the dopamine receptors in the pituitary gland and almost always normalizes the prolactin level and corrects the related problems. Prolactinomas often shrink during treatment, and sometimes regress completely. Spontaneous regression is possible as well.

Bromocriptine has been shown to be safe in pregnancy, although the drug can be withdrawn once pregnancy is established. Bromocriptine is started at 1.25 mg/day and is gradually increased to 5 mg twice daily if prolactin levels do not decrease. The normal expansion of the pituitary gland in pregnancy with normally high prolactin levels may occasionally cause progression of the tumor, although this is rare (except with macroadenomas). Medication can be reinstituted during pregnancy if symptoms, such as headache or visual symptoms, occur.

Other dopamine agonists, such as cabergoline (Dostinex), have been approved for use in this condition by the US Food and Drug Administration.

Cabergoline has a longer half-life and purports to have fewer of the side effects (eg, nasal congestion, dizziness, and hypotension) associated with most dopamine agonists. Cabergoline dosing

To assess prolactin levels, blood should be drawn in a fasting state in the morning to avoid spurious elevations from food intake or time of day. starts at 0.25 mg twice weekly and may be increased up to 1 mg twice weekly.

There have been reports of the longacting dopaminergic agents causing cardiac valve disease, because of receptors in the heart; this seems to largely occur with long-term use and high doses.

Vaginally administered bromocriptine has been used to avoid some of the side effects as well. As with other drugs, the lowest dose for the shortest time is the correct path to follow. It is reasonable to stop medication after 1 to 2 years and reassess the continued need for treatment. The same is true postpartum, because persistent improvement in the condition with or without a tumor has been reported following extended therapy or pregnancy.

Conclusion Some tumors do not respond to medical treatment; sometimes the tumors are not prolactinomas but rather nonfunctional tumors that cause disruption of the dopamine pathways in the pituitary gland, which may require surgery.

Resistance of the prolactin level to normalization may be an indication for surgery, especially if there are ocular or neurologic symptoms. â&#x2013;

LETTERS We encourage readers to send letters in response to articles appearing in this publication, or in relation to relevant topics to nursing that may be of interest to readers.

Please include your name, affiliation, and address, and indicate the relevant article or topic. Letters may be edited for clarity and space if necessary.

Mail to: Letters, OBGYN and Infertility Nurse 241 Forsgate Drive, Suite 205D Monroe Twp, NJ 08831 Fax: 732-992-7938 E-mail: lara@novellushc.com

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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:

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Fertility Preser Focus of Ferti vation the lity Institute

EMERGING QUESTIONS

Will HPV Scree the Pap Smea ning Replace r?

Interview with Kutluk

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).

Oktay, MD, FACO Professor of Obste G 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

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

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 ertheless, in its Nev29 years, screen new practice guidel ing every 2 years (Obstet Gynec only ines • Optional ol. 2009;114:1 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 screen changes to cervic cytology screen ing al betwe 65 en and 70 years, 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;

D

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 role nurse for patients with s play in and fertility preservation cancer other chronic . diseases. Altho the majority of our patients currenugh tly

Safety of VTE Pregnant Wo Prophylaxis in men Varies

Continued on page

By Wayne Kuzna r

F

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 The ialPubli Publicatio cationnofof

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for issues such as coverage and reimbursement.

We thank Colum bia Laborator for their gold ies, Inc., level support. ©2010 Novellu s Healthcare Comm unications, LLC

Continued on page

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

N

urses working in the field of infertility can attest to the rewards and challe nges of sharing pregnancy test results patients. Noth with ing able to make that is better than being the news—“you’r phone call to deliver e pregnant.” In trast, sharing test conresult s can be one of the most difficu lt tasks for the infertility nurse. Test results are not easy to discus always 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

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

A

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

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Continued on page

Pharmacy Corn Infertility Medicationer Storage

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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

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8

The Infertility Nurse

New Method to Predict IVF Success after First Failure

By Rosemary Frei, MSc

C

urrently, the prognosis for future success of in vitro fertilization (IVF) is based mainly on information related to the age of the patient.

Researchers have now taken a significant step toward predicting whether, after an unsuccessful round of IVF treatment, a subsequent cycle will result in a live birth.

As infertility nurses are well aware, the failure rate for first IVF attempt is high, and women undergoing treatment have to consider the emotional and financial burden in their decision of what their next step should be.

Therefore, the publication of a new study can offer patients and nurses help in that dilemma.

The study investigators identified the 10 factors that have the most influence on IVF success (Banerjee P, et al. Deep phenotyping to predict live birth outcomes in in vitro fertilization. Proc Natl Acad Sci USA. 2010 July 19. Epub ahead of print). They grouped these factors together, showing that their use in aggregate is approximately 17% more accurate than the current age-based method of IVF success prediction.

Information on all 10 factors is routinely gathered in IVF clinics after each round of IVF. Findings from this study suggest that the 5 most important factors to consider in assessing a future IVF success, in this order, are: 1. Higher rates of blastocyst formation from fertilized eggs 2. Total amount of gonadotropin that is administered 3. The number of 8-celled embryos 4. Whether the transferred embryos were cryopreserved 5. The age of the patient.

“Since we’ve proved that chronological age is not the primary predictor of IVF live-birth outcomes, descriptive information about their embryos and treatment parameters from a previous cycle may be used in conjunction with other clinical information to provide prediction that is specific, and thus more meaningful, to each individual patient,” lead author Prajna Banerjee, PhD, a postdoctoral fellow in Obstetrics and Gynecology, Stanford University School of Medicine, CA, told the OB/GYN and Infertility Nurse.

“Our findings show that the first IVF cycle can provide quantitative, customized prediction of the live-birth probability in a subsequent cycle,” Dr Banerjee wrote in the article. “This concept is radically different from the current paradigm, in which age is a major predictor.”

Selwyn Oskowitz, MD, a Reproductive Endocrinologist at Boston IVF in Wal-

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by including other factors, such as ethnicity, that are available before the start of IVF. The goal is to help women and their partners “make an improved and informed decision about even their first IVF cycle,” she said. ■

“The first IVF cycle can provide quantitative, customized prediction of the live-birth probability in a subsequent cycle….This concept is radically different from the current paradigm, in which age is a major predictor.”—Prajna Banerjee, PhD tham, MA, commented that although the study is a good attempt to improve clinical acumen, the results contain “few surprises.” Nevertheless, she noted, it does provide a new approach.

“All reproductive endocrinology providers mentally compute age of the female, prior term births, FSH [folliclestimulating hormone] levels, egg and embryo numbers, and others into our current predictive counseling,” Dr Oskowitz said. “However, this paper does reinforce other factors not frequently utilized, such as the age of the male.”

Lead investigator Mylene Yao, MD, and coinvestigator Wing H. Wong, MD, have founded Univfy, Inc. Based on these study data, they said they intend to develop and market a tool for predicting IVF success in routine clinical practice.

Researchers used “deep phenotyping” to place patients in groups according to their likelihood of producing a live birth after IVF. The team analyzed data and outcomes from 1676, 732, and 300 first-, second-, and third-cycle IVF treatments, respectively, completed between 2003 and 2008 at the Stanford IVF clinic at Stanford University’s Department of OB/GYN. Data analysis revealed that 30 firstcycle–related variables were significantly associated with live births in subsequent cycles. They then performed a boosted-tree methodology to generate a model capable of predicting live-birth outcomes, which showed that the rate of blastocyst development has a 26% relative influence on a positive outcome.

The relative influences for other variables were the total amount of gonadotropin administered, 10%; number of 8-celled embryos, 9%; embryo cryopreservation, 7%; age of the woman, 6%; endometrial thickness, 6%; and total number of embryos, 6%. The 3 other variables with significant influence were the average number of cells per embryo, the patient’s body mass index, and the partner’s age.

The team validated the influence of these variables using another 634 firstcycle and 230 second-cycle cases from their IVF clinic between 2007 and 2008. They found that each of the 10 variables was significantly associated with live-birth outcomes and that, in

Did you know…?

aggregate, they provided a significantly more accurate prediction of live-birth outcomes than age alone.

Hence, these variables can be used to accurately predict live-birth outcomes for women who have only undergone 1 round of IVF, they concluded.

Dr Banerjee noted that the team is continuing to improve and broaden the prediction power of their approach

• Approximately 75% of in vitro fertilization (IVF) treatment cycles do not result in a live birth.

• 1% of newborns in the United States have been conceived by IVF treatment.

• Since the inception of IVF treatment, 1 million newborns worldwide have been conceived that way.

Ovarian Insufficiency Linked to BRCA1 Mutation

By Caroline Helwick

S

ome cases of primary ovarian insufficiency appear to be linked to mutations in the BRCA1 gene. BRCA gene mutations are associated with susceptibility to breast and ovarian cancers, and this may be linked to low response to ovarian stimulation.

“We showed a novel association between low response to ovarian stimulation and BRCA1 mutations, which suggests a possible link between DSB [double-strand DNA break] repair gene function, infertility, and breast/ ovarian cancer risks,” said principal investigator of the study, Kutluk Oktay, MD, FACOG, of the Institute for Fertility Preservation at New York Medical College/Westchester Medical Center, Valhalla (Oktay K, et al.

Association of BRCA1 mutations with occult primary ovarian insufficiency. J Clin Oncol. 2010;28:240-244).

For the purpose of fertility preservation by embryo or oocyte cryopreservation, Dr Oktay’s team performed ovarian stimulation in 82 patients with breast cancer using the aromatase inhibitor letrozole (Femara) concurrently with gonadotropins. As surrogates of ovarian reserve, the oocyte yield and incidence of low response were compared according to BRCA mutation status.

The hypothesis for the study evolved when Dr Oktay and his colleagues were evaluating this low-estrogen-exposure method of ovarian stimulation. “We repeatedly encountered young patients with breast cancer who have no history of infertility and who unexpectedly have had low response

to ovarian stimulation,” he said. They hypothesized that mutations in the BRCA gene may be associated with low response to fertility treatment.

Of the 82 women, 47 had undergone BRCA testing and 14 were found to have a mutation in BRCA1 or BRCA2.

The BRCA mutation–positive patients were significantly more likely to have a poor response to ovarian stimulation than those without the mutation (33.3% vs 3.3%, respectively).

Women with BRCA1 mutation produced a lower number of eggs and were up to 38 times more likely to have low response to stimulation.

Compared with controls, women with BRCA1 (but not BRCA2) mutations produced a lower number of eggs (7.4 vs 12.4 on average) and were up to 38 times more likely to have low response to stimulation.

The authors concluded that BRCA1 mutations are associated with occult primary ovarian insufficiency. “The finding may, at least in part, explain the link between infertility and breast and ovarian cancer risks,” they wrote. They suggest that assessing women with infertility and low response to ovarian stimulation for the BRCA gene “may be worthwhile, especially when there is a family history of these cancers.” ■

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The Urology Nurse

Simple Intervention Boosts Sperm...

4-fold. “Even though our study was observational, our results highlight the importance of educating our colleagues in the oncology world about this resource,” Daniel H. Williams, IV, MD, Assistant Professor of Urology and Director of Male Reproductive Medicine and Microsurgery, University of Wisconsin, Madison, said in an interview with the OB/GYN and Infertility Nurse.

Dr Williams’s team compared sperm cryopreservation rates before and after the lecture, which focused on the risks of cancer treatment–induced male infertility, advances in assisted reproductive technology, and the local availability of sperm cryopreservation.

The dramatic increase in sperm cryopreservation seen 1 month after a single lecture was maintained at follow-up several months later.

Because of therapeutic advances, pediatric and adult cancer survivors are living “well into” their reproductive years, Dr Williams pointed out.

However, most cancer treatment regimens have adverse effects on testicular function and male reproductive potential, and posttreatment fecundity is difficult to predict.

Continued from page 1

that semen cryopreservation be adopted as standard practice.

In contrast, epidemiologic studies indicate that most young male cancer patients are not advised to bank sperm

“Cancer treatments now focus not only on survival but on quality of life, and fertility and fertility potential is a large component of quality of life after cancer treatment.”—Daniel H. Williams, IV, MD Sperm cryopreservation provides an opportunity to preserve a man’s fertility before cancer treatment, Dr Williams said. The American Society of Clinical Oncology has recommended that oncologists routinely discuss the potential for infertility along with fertility preservation options with patients before cancer therapy and refer interested patients to reproductive specialists.

In addition, the guidelines recommend

before their cancer treatment. Surveys have consistently identified a lack of information as the main reason for the low sperm cryopreservation rate.

About 40 healthcare practitioners attended the lecture. Attendees were mostly pediatric and adult oncologists but also included oncology nurses and other staff.

In the 24-month period before the lecture, only 1 patient with cancer per

month banked his sperm. After the lecture, the rate increased significantly, to 3.7 patients with cancer per month over the subsequent 7 months after the lecture (P <.001).

Most of the change was comprised of a nearly 6-fold increase in the number of patients with nontesticular cancer, from 0.42 to 2.42 per month (P <.001).

“With improvements in cancer therapies, young men of reproductive age who develop cancers—lymphomas, leukemias, and testicular malignancies, among others—are surviving longer,” Dr Williams said. “As a result, cancer treatments now focus not only on survival but on quality of life, and fertility and fertility potential is a large component of quality of life after cancer treatment.”

Continued efforts should be made to educate healthcare professionals about sperm cryopreservation, with an emphasis on improving the comprehensive cancer care and posttreatment quality of life in these patients, he added. ■

BPH Drug Improves Ejaculatory Dysfunction, a Common Condition in Older Men irritative (frequency, urgency, and 67% of men said they were strongly

By Jill Stein

E

rectile dysfunction (ED) is perhaps the most often-discussed form of sexual dysfunction in men, but few may know that ejaculatory dysfunction affects approximately 50% of all men aged ≥50 years and usually causes significant bother, said John M. Fitzpatrick, MD, Professor of Surgery and Consultant Urologist, Mater Misericordiae Hospital and University College, Dublin, Ireland, during the 2010 annual meeting of the European Association of Urology Congress.

Ejaculatory dysfunction is considered problematic by roughly: • 33% of men with mild lower urinary tract symptoms (LUTS) • 50% of men with moderate LUTS • 66% of men with severe LUTS. Dr Fitzpatrick and colleagues examined the impact of 6 months of treatment with alfuzosin, a uroselective alpha-1 adrenergic receptor blocker, on ejaculatory dysfunction. Alfuzosin is approved for the treatment of benign prostatic hypertrophy (BPH) symptoms.

Sexual dysfunction is very prevalent in aging men with LUTS suggestive of BPH and is associated with significant adverse effects on quality of life and overall well-being, Dr Fitzpatrick pointed out. Alfuzosin 10 mg once daily, administered without dose titration, appears to be effective for treating this patient population.

Validated questionnaires that assess

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male sexual function, including the International Index of Erectile Function Questionnaire and the Brief Male Sexual Function Inventory, focus primarily on ED, with few or no questions

Ejaculatory dysfunction affects approximately 50% of all men aged ≥50 years and usually causes significant bother. seeking information on ejaculation problems, Dr Fitzpatrick said. The Danish Prostate Symptom Score offers the advantage of assessing 2 ejaculatory dysfunction symptoms—the amount of ejaculate and pain/discomfort on ejaculation; however, its psychometric properties have not been evaluated.

The present study used the following 2 questionnaires: • The Male Sexual Health Questionnaire short-form, which is a validated tool that assesses 3 ejaculatory dysfunction symptoms (reduced ability to ejaculate during sexual activity, decreased strength/force of ejaculation, and decreased amount/volume of semen) and bother resulting from ejaculatory dysfunction • The International Prostate Symptom Score (IPSS), which consists of 7 questions that assess the severity of

nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing/ straining) symptoms.

Results of 1123 patients who completed the 6-month treatment period showed that alfuzosin significantly improved the IPSS and nocturia compared with baseline measures. The percentage of men who reported waking up at least 3 times at night decreased from 48.1% at baseline to 16.8% at study end.

Bother resulting from LUTS was also significantly improved. At enrollment,

bothered by LUTS versus 19% at the end of treatment.

Results showed that ejaculatory dysfunction and bother resulting from ejaculatory dysfunction, which were very prevalent at enrollment, significantly improved with alfuzosin. Alfuzosin was well tolerated.

The study also showed a significant increase in the percentage of men having no ejaculatory dysfunction and a significant decrease in the percentage of men reporting bother resulting from ejaculatory dysfunction. Benefits occurred in men aged <70 years. ■

Anejaculation Common after Radiotherapy for Prostate Cancer

M

ost men who undergo radiation therapy (RT) for prostate cancer will develop anejaculation over time, according to Doron Stember, MD, a urology fellow at Memorial SloanKettering Cancer Center in New York City, who presented at the American Urological Association 2010 annual meeting the results of a study that examined the ejaculation profiles of 364 men who underwent localized RT for prostate cancer.

“It is widely known that anejaculation occurs after a radical prostatectomy and may be a significant cause of bother and sexual dissatisfaction,” Dr Stember said. “In contrast, patients

and physicians do not commonly associate radiation therapy with anejaculation. We undertook this study because our clinical experience has suggested that many men do, in fact, lose antegrade ejaculatory function after RT.” The overwhelming majority of prior analyses of patients with pelvic RT-associated sexual dysfunction have focused on erectile dysfunction, often without mention of changes in ejaculatory dysfunction. Anejaculation is thought to result from a progressive scarring mechanism in the prostate tissue (including the ejaculatory ducts) that leads to obstruction of the ejaculate.

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Nutrition

Omega-3 Fish Oil Supplementation Reduces Symptoms of Major Depression

By Rosemary Frei, MSc

N

ow there is another reason to praise the power of omega-3 polyunsaturated fatty acids, according to results of a new randomized, controlled trial.

“Based on our results, it would make sense for people with a major depressive episode and without comorbid anxiety disorders to take omega-3 supplements,” lead investigator François Lespérance, MD, Chief of Psychiatry, Centre Hospitalier at the Université de Montréal, Québec, Canada, told the OB/GYN and Infertility Nurse.

This new study has shown that supplements containing these popular substances significantly reduce the severity of major depression in people without comorbid anxiety disorders (Lespérance F, et al. The efficacy of omega-3 supplementation for major depression: a randomized controlled trial. J Clin Psychiatry.

2010 June 15. Epub ahead of print).

Dr Lespérance and colleagues randomized 432 adult outpatients who had experienced a major depressive episode (MDE) to either 3 capsules daily of an omega-3 fish oil supplement or to a matched sunflower oil placebo.

They found that patients with an MDE and no comorbid anxiety disorders who took the omega-3 fish oil supplement for 8 weeks had a significant reduction in scores on 2 scales—the self-reported Inventory of Depressive Symptomatology (IDS) and the Montgomery-Åsberg Depression Rating Scale (MADRS)—compared with similar patients taking a matched sunflower oil placebo. Patients with an MDE and

Anejaculation...

Continued from page 26

Overall, 16% of the men in this study complained of anejaculation at 1 year, 69% at 3 years, and 89% at 5 years.

“There was a clear trend toward an increasing proportion of patients experiencing anejaculation…after RT,” he said. The risk factors for failure to ejaculate at 3 years included: • High RT doses • Older age • A history of androgen deprivation therapy • Smaller prostates at the time of RT. Orgasm domain scores on the widely validated International Index of Erectile Function questionnaire decreased markedly throughout follow-up. “We recommend that the high likelihood of inability to ejaculate should be discussed with men prior to RT,” Dr Stember advised.—JS ■

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a comorbid anxiety disorder, however, did not benefit appreciably from the omega-3 supplements.

“To our knowledge, this is the largest ever conducted [study] testing the efficacy of omega-3 supplements for treating MDE,” Dr Lespérance and colleagues wrote.

“Based on our results, it would make sense for people with a major depressive episode and without comorbid anxiety disorders to take omega3 supplements.”

—François Lespérance, MD Dr Lespérance said that they conducted the study for 2 reasons. First, because many people who experience an MDE do not respond sufficiently to antidepressant treatment or do not tolerate these medications. Second, evidence is accumulating that a relative deficiency of omega-3 fatty acids contributes to depression.

They conducted a double-blind, placebo-controlled, parallel-group trial between October 2005 and January 2009 to help determine whether omega3 fatty acids are effective for MDE. Patients were recruited through adver-

tisements, referrals from physicians, and the investigators’ own caseloads.

Criteria for inclusion in the study were age ≥18 years, meeting the diagnostic criteria for an MDE, and having had clinically significant depressive symptoms for at least 4 weeks.

Participants were randomized into 2 groups—(1) a daily omega-3 supplement (n = 214) and (2) matched sunflower oil placebo (n = 218). The 2 groups were well-balanced, with a similar average age (46.6 and 45.4 years, respectively); most participants were female, unmarried, and had an average of about 15 years of education. Comorbid anxiety disorder prevalence was also similar in both groups.

Although there were no statistically significant differences in depression symptoms improvement between the 2 groups after the trial, patients without comorbid anxiety disorders benefited from omega-3 supplementation—they showed significantly larger improvements on the 2 depression scales (IDS and the MADRS).

Both groups had several serious adverse events. In the omega-3 supplementation group, 7 events occurred: • 1 recurrence of pre-existing neuropathic pain • 1 episode of acute thrombophlebitis • 1 myocardial infarction • 1 case of significant worsening depression

• 1 overdose of acetaminophen • 2 cases of hypomania, including 1 patient receiving adjunctive antidepressant treatment.

In the control group, 4 events occurred: • 1 case of rectal bleeding • 1 increase in palpitations in an individual with pre-existing auricular tachycardia • 2 episodes related to alcohol withdrawal in 1 person. ■

Omega-3 Fatty Acids The use of omega-3 supplementation has been gaining popularity as a good way to protect against heart disease.

Dietary sources of omega-3 fatty acids include fish oil and some vegetable oils (canola, soybean, flaxseed, olive) and walnuts. Fish oil contains DHA and EPA, and the vegetable oils contain alpha-linolenic acid (ALA).

Increasing evidence suggests that these substances—DHA, EPA, and ALA—reduce the risk for heart disease, including heart attacks and stroke, in patients with cardiovascular risk factors.

This study suggests that omega-3 supplements may have additional benefits for other populations.

Vitamin D Linked to Pelvic Floor Disorders in Women

By Jessica A. Smith

I

n line with the barrage of evidence for the importance of vitamin D, there is one more reason for women to make sure they are getting enough of this vitamin: higher levels of the vitamin are associated with a decreased risk for pelvic floor disorders, including urinary and fecal incontinence and pelvic prolapse. The risk increases with age in women.

“Our findings suggest that treatment of vitamin D insufficiency and deficiency in both premenopausal and postmenopausal women could improve pelvic muscle strength, with a possible reduction in the prevalence of pelvic floor disorders including urinary incontinence,” wrote the researchers of this recent study (Badalia SS, et al. Vitamin D and pelvic floor disorders in women.

Obstet Gynecol. 2010;115:795-803).

One in 4 women in the United States has pelvic floor problems, and the fre-

quency of these conditions increases with age. In this new study, the investigators used data from the 2005-2006 National Health and Nutrition Examination Survey to examine possible association between vitamin D levels and pelvic floor disorders in women.

Treating vitamin D insufficiency and deficiency with vitamin D supplementation can improve urinary incontinence, especially in postmenopausal women.

Data were used for 1881 nonpregnant women aged ≥20 years whose records included information about vitamin D levels and pelvic floor disorders. Vitamin D level below the nor-

mal range was defined as 25-hydroxyvitamin (OH) D <30 ng/mL. Approximately 82% of the women had low levels of vitamin D (25[OH]D <30 ng/mL). Mean vitamin D levels were significantly lower in women who reported 1 or more pelvic floor disorders, a group comprising 23% of the total study population. Levels of vitamin D were also significantly lower in women with urinary incontinence.

In older women, a decrease in risk for urinary incontinence was also observed when vitamin D levels were within the normal levels—25(OH)D ≥30 ng/mL. Overall, researchers found that increased vitamin D levels were associated with a significantly lower risk for 1 or more pelvic floor disorders.

In addition, the risk for urinary incontinence was significantly diminished in women aged ≥50 years with 25(OH)D levels ≥30 ng/mL. ■

August 2010 I Vol 2, No 4

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