December 2010, Vol 2, No 6 by Novellus Healthcare Communications, LLC

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DECEMBER 2010

WWW.OBGYN-INFERTILITY-NURSE.COM

VOL 2, NO 6

e AWHONN HIGHLIGHTS

CLINIC PROFILE

The Fertility Institute of New Orleans Preventing Maternal Deaths Strength in Numbers

What Nurses Can Do

Interview with Mary M. MacGregor, RNC IVF Nurse Coordinator, Fertility Institute of New Orleans, LA

By Caroline Helwick

alf the reported maternal deaths in the United States could have been prevented by early diagnosis and treatment, according to the Centers for Disease Control and Prevention. This and other important information regarding maternal mortality was conveyed at the Association of Women’s Health, Obstetric and Neonatal Nurses 2010 meeting by Suzanne McMurtry Baird, MSN, RN, of Vanderbilt University School of Nursing, Nashville, TN. “Maternal deaths are rare,” she noted. “But when they happen they are devastating, not only to families but to the obstetrical staff.”

Whereas a recent or current pregnancy need not be listed on a death certificate, maternal (pregnancy-related) deaths are thought to be underestimated. They are reported via the “honor system,” no penalties are levied for misreporting or failing to report them, no standard reporting system exists, and a confidential review of all maternal deaths (which would help to identify causes and inform preventive efforts) is not required, according to Ms Baird. US Mortality Rate Too High The overall US maternal mortality rate in 2006 was 13.3 per 100,000 live Continued on page 12

he staff at the Fertility Institute of New Orleans (FINO) prides itself on having achieved more than 10,000 pregnancies for patients, providing evidence for their motto, “We help bring dreams to life.” With offices in Metairie, Mandeville, and Baton Rouge, FINO positions itself to meet the fertility needs of patients

throughout Louisiana. We spoke with Mary MacGregor, RNC, to find out more about the clinic.

Could you describe the staff at FINO? Oftentimes, the reputation of a fertility clinic emanates from the reputation of a particular individual at the Continued on page 6

ASRM HIGHLIGHTS

Moderate Stress May Be Good Before IVF Cycles But Coping Skills during Cycles Are Crucial By Wayne Kuznar

ndergoing in vitro fertilization (IVF) can be stressful for many women, but results from 2 studies presented at the 2010 meeting of the American Society for Reproductive Medicine suggest that some stress can actually be advantageous for IVF outcomes.

“Some distress prior to cycle initiation is beneficial, as long as patients have the skill to decrease their level of stress [during their cycle],” said Alice D. Domar, PhD, Director of the Mind/ Body Center for Women’s Health at the Mind/Body Medical Institute and Beth Continued on page 10

The Official Publication of

SPOTLIGHT

They Called Him Noah IVF Lessons from Katrina

Sissy Sartor, MD Reproductive Endocrinologist, Fertility Institute of New Orleans, LA

©Copyright Bigstock.com/Tashka

Left to right, seated: Steven Taylor, MD; Richard P. Dickey, MD, PhD; standing: Peter Lu, MD; Sissy Sartor, MD.

hey called him Noah, and he became a symbol of hope for our community—a community defined by the Fertility Institute of New Orleans’ (FINO’s) staff, patients, city, and region. His journey began long before Katrina roared onto the shores of Louisiana on August 29, 2005, with sustained winds of 140 mph, long before the subsequent breaks in the levees and canals, and long before the dark water came perilously close to washing away our lives. His journey began as 1 of 5 embryos frozen in the

New Orleans waterfront.

FINO in vitro fertilization (IVF) facility on December 6, 2003. That IVF cycle took place in our east New Orleans IVF laboratory, which was inundated with 8 feet of floodwater in the aftermath of Katrina. Two days before the predicted landfall of Katrina, the Dewar tanks that contained Noah and 1747 other Continued on page 7

Inside Infertility Updates Why Age Matters, Page 8 Ethical Issues in ART, Page 11 Women’s Health Don’t Ignore Risks for Late-Preterm Newborns, Page 16 New Early Labor Detector, Page 17

Complimentary CE Credit Genetic Counseling: Family History Risk Assessment, Page 18

The Cancer Patient Sexuality Problems in Breast Cancer Survivors, Page 22 Meeting Coverage ASRM, AWHONN, ESMO, NAMS, SUNA

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CONTENTS

december 2010 • Vol 2 • No 6

PUBLISHING STAFF

Publisher 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 Nurse-NP/PA is the official publication of the American Academy of OB/GYN Nurses. The OB/GYN Nurse-NP/PA provides practical, authoritative, cutting-edge information on the physiologic, medical, and psychological aspects of women’s health, focusing on the role of the OB/GYN practitioner, including nurses, NPs, and PAs, in patient care. Our journal offers a forum for nurses, nurse practitioners, physician assistants, administrators, researchers, and all others involved in OB/GYN and women’s health to discuss the entire scope of current and emerging diagnostic and therapeutic options, as well as counseling and patient follow-up for women throughout their reproductive years and beyond. Written by nurses for nurses, The OB/GYN NurseNP/PA promotes peer-to-peer collaboration among all nursing professionals toward the advancement of integrated services for optimal delivery of patient care and offers continuing education for all nurses, NPs, and PAs involved in these interrelated fields of women’s health.

FROM THE EDITORS

4 Thank You for a Successful Year of Publication CLINICAL NEWS

5 Low Testosterone Linked to Premature Mortality in Men with CHD 7

Extreme Low/High Neonatal Vitamin D a Risk for Adult Schizophrenia ACOG Relaxes Guidelines for Vaginal Birth after Cesarean

6 Metabolic Markers May Predict Preeclampsia 11 FDA Issues Warning for Sexual Enhancement Supplement 27 New Combination OC with Lowest Estrogen Dose Novel Spermicide on Par with Nonoxynol-9 IOM Ups Vitamin D & Calcium Recommendations for Most Americans

INFERTILITY UPDATES

8 Why Age Matters: Medical, Psychological Aspects of Pregnancy in Older Age ASRM Highlights

9 Misoprostol Equal to Surgery in Resuming Fertility Treatment after Pregnancy Loss ASRM Highlights

10 Patients Not Absorbing Key Messages from Fertility Preservation Consultation ASRM Highlights

11 In ART, Ethical Issues Still Thorny AWHONN Highlights 17

WOMEN’S HEALTH

14 Prenatal Medical Food Maintains Hemoglobin Levels in Pregnancy ASRM Highlights

15 Stopping Hormone Therapy Increases Hip Fracture Risk in Postmenopausal Women NAMS Highlights Bone Density Scans Too Often Ordered Inappropriately NAMS Highlights B12 Status Can Make or Break Alzheimer’s Risk

16 Do Not Ignore the Risks for Late-Preterm Newborns AWHONN Highlights

Laparoscopic Hysterectomy Fast and Safe The OB/GYN Nurse, ISSN 2153-6562 (print); ISSN 2153-6546 (online), is published 6 times a year by Novellus Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831. Copyright ©2010 by Novellus Healthcare Communications, LLC. All rights reserved. The OB/GYN Nurse is a trademark of Novellus Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. The ideas and opinions expressed in The OB/GYN Nurse do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher. Publication of an advertisement or other product mentioned in The OB/GYN Nurse should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issue, $17.00. Orders will be billed at individual rates unless proof of status is confirmed. SUBSCRIPTIONS/CHANGE OF ADDRESS should be directed to CIRCULATION DIRECTOR, The OB/GYN Nurse, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831; Fax: 732-656-7938.

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17 Early Labor Detector May Offer Enhanced Outcomes H1N1 Flu in Pregnancy Poses a Serious Risk to Mother, Fetus

CONTINUING EDUCATION

18 Genetic Counseling: Family History Risk Assessment 20 Commentary: Understanding Reproductive Genetics THE CANCER PATIENT

21 Breastfeeding Safe in Breast Cancer Survivors ESMO News 22 Fertility Concerns of Cancer Survivors Require More Attention ESMO News Clinicians Ignore Sexuality Problems in Breast Cancer Survivors ASCO Breast Cancer News

NUTRITION

24 Helping Your Patients Eat Right to Stay Healthy AWHONN Highlights Supplements Claiming to Be Black Cohosh Often Are Not

MEN’S HEALTH

26 Should We Really Be Using PSA? SUNA Highlights ED Drug Use Linked to STDs in Men

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From the Editors

Thank You for a Successful Year of Publication

s we near the end of our first full year of publication, it is exciting to reflect on our successes during 2010. Since the inception of this publication in October 2009, we have created a forum for nurses and allied healthcare professionals to exchange ideas and share the best of what makes our specialties unique and rewarding. Along with presenting clinical topics pertinent to the OB/GYN, urology, and reproductive endocrinology fields, we have shared clinic profiles, answered emerging clinical practice questions, highlighted national workshops and conferences, and offered continuing education opportunities for our nursing readers. Our journal offers a forum for nurses, nurse practitioners, physician assistants, administrators, researchers, physicians, and the entire team of experts involved in OB/GYN, infertility, and urology to discuss clinical care issues unique to our practices and to share clinical care knowledge designed to enhance the care we provide to men and women throughout their reproductive years and beyond.

We have been delighted by the positive feedback we have received from our nursing, physician, and allied health colleagues. As an interactive publication written for nurses and other team members of the infertility and women’s health community, we thank you, our readers, for making our journal an overwhelming success. We look forward with excitement to the continued collaboration with you, our colleagues, as well as to the educational opportunities that 2011 is sure to bring to us all. We invite each one of you to send us your articles, comments, and suggestions for the coming year. Please contact us at editorial@novellushc.com.

Sue Jasulaitis, RN, MS, and Deborah Moynihan, WHNP-BC, MSN Co-Editors-in-Chief

Happy

New Year

Editorial Board CO-EDITOR-IN-CHIEF

Donielle Farrington, RNC

Kutluk Oktay, MD, FACOG

Sue Jasulaitis, RN, MS

Clinical Nursing Manager Brunswick Hills OB/GYN, NJ

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

CO-EDITOR-IN-CHIEF

Sandra Fernandez, RPh, PharmD

Debra Moynihan, WHNP-BC, MSN

Pharmacist Mandell’s Clinical Pharmacy, NJ

Cyndi Gale Roller, PhD, RN, CNP, CNM

Clinical Research Manager Fertility Centers of Illinois, Chicago

Women’s Health Nurse Practitioner Carolina OB/GYN, SC

Barbara Alice, RN, APN-C, MSN

Jennifer Iannaccone, RNC

Christopher S. Sipe, MD

Nursing Manager, IVF Coordinator South Jersey Fertility Center

Nursing Manager, IVF Coordinator IVF New Jersey

OB/GYN & Reproductive Endocrinology Fertility Centers of Illinois, Chicago

Monica R. Benson, BSN, RNC

Juergen Liebermann, PhD, HCLD

Harvey J. Stern, MD, PhD

Nurse Manager Third Party Reproduction, RMA New Jersey

IVF Laboratory Director River North Fertility Centers of Illinois Chicago

Director, Reproductive Genetics Genetics & IVF Institute Fairfax, VA

Melissa B. Brisman, Esq

Donna Makris, RN, BSN, IBCLC

Kriston Ward, RN, MS, NP-C

Owner Reproductive Possibilities, LLC Surrogate Fund Management, LLC

Parent Education Coordinator OB/GYN, St. Peter’s Medical Center, NJ

Strong Fertility Center University of Rochester Medical Center Rochester, NY

Kit Devine, MSN, ARNP

Mary M. Macgregor, RNC

Joan Zaccardi, MS, DrNP

Advanced Nurse Practitioner Fertility & Endocrine Associates, Kentucky

IVF Nurse Coordinator Fertility Institute of New Orleans, LA

Administrative Practice Manager Urogynecology Arts of New Jersey

Richard P. Dickey, MD, PhD

Jill Marchetti, RN

Director, Reproductive Medicine Fertility Institute of New Orleans, LA

Director, Egg Donor Program IVF New Jersey

Gina Paoletti-Falcone, RN, BSN

Norah S. Nutter, MSN, WHNP-BC, IBCLC

Clinical Services Manager Freedom Fertility Pharmacy Byfield, MA

Program Director, Women’s Health College of Nursing Kent State University, OH

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Women’s Health Nurse Practitioner Magnolia OB/GYN Myrtle Beach, SC

Carolyn E. Keating, BSN, RNC, NP Piedmont Reproductive and Endocrinology Group Greenville, SC

Patricia Rucinsky, RN, BSN Clinical Nurse Manager IRMS, St. Barnabas, NJ

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Clinical News Low Testosterone Linked to Premature Mortality in Men with CHD

ACOG Relaxes Guidelines for Vaginal Birth after Cesarean

For men with coronary heart disease (CHD), serum testosterone deficiency can be a harbinger of premature death, a recent longitudinal study of 930 men with CHD showed (Malkin CJ, et al. Heart. 2010;96:1821-1825). The study included men with confirmed CHD, who were recruited between 2000 and 2002 and followed up for a mean of approximately 7 years. The overall prevalence of biochemical testosterone deficiency using bioavailable testosterone level <2.6 nmol/L was 20.9%; using total testosterone <8.1 nmol/L, 16.9%; and using either measure, 24%. Mortality rates more than doubled for men with testosterone deficiencies compared with those with normal levels of the hormone. However, whether low testosterone is the cause for early death or a marker for mortality risk is still unknown. The researchers noted that studies are needed to assess the benefits of testosterone replacement therapy on survival in patients with CHD. Other factors associated with time to allcause and vascular death in this patient population included leftventricular dysfunction, aspirin therapy, and beta-blocker therapy.

The American College of Obstetricians and Gynecologists (ACOG) has issued less stringent recommendations for trial of labor after cesarean (TOLAC) and for vaginal birth after cesarean (VBAC), acknowledging that VBAC is linked with a reduction in maternal death and complications

in future pregnancies (ACOG. Obstet Gynecol. 2010;115:450-463). The new recommendations state that VBAC is a safe and appropriate choice for the majority of women, including some who have had 2 previous cesareans. The new guidelines state that women with 2 (compared with 1 in the older guidelines) previous low-transverse cesarean incisions, women carrying twins, and women

with an unknown type of uterine scar are viable candidates for VBAC. The revised guidelines also suggest that epidural analgesia may be used for TOLAC, and that misoprostol should not be used for third-trimester cervical ripening or for labor induction. Labor induction, however, is permissible when appropriate, using different means, in women undergoing TOLAC. Continued on page 27

Extreme Low/High Neonatal Vitamin D a Risk for Adult Schizophrenia In neonates, vitamin D status at the very high or very low end of the spectrum can mean an elevated risk for schizophrenia later in life, according to the results of an individually matched case-control study of 848 individuals in Denmark (McGrath JJ, et al. Arch Gen Psychiatry. 2010;67:889-894). The study population consisted of 424 persons with schizophrenia, matched for sex and date of birth with 424 controls. Using neonatal dried blood samples, the researchers measured the concentrations of 25hydroxyvitamin D3 (25[OH]D3) in both groups. Neonates in the lowest 3 of 5 quintiles had a 2-fold risk for schizophrenia compared with those in the fourth quintile, whose 25(OH)D3 levels were between 40.5 nmol/L and 50.9 nmol/L. More surprising to the researchers was the discovery that infants in the highest quintile also had an increased risk for schizophrenia. â&#x20AC;&#x153;In light of the substantial public health implications of this finding, there is an urgent need to further explore the effect of vitamin D status on brain development and later mental health,â&#x20AC;? the investigators wrote.

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Clinic Profile

The Fertility Institute of New Orleans... clinic, an expert whose prominence in research and/or clinical practice gives credibility to the program, and whose mere presence is in itself a “stamp of approval” of quality care. At FINO, however, we prefer to rely on a paradigm of fertility care based on the experience and input of our entire staff of clinicians. As the Gulf South’s first and largest

OB/GYN and infertility, serving on many committees that affect national policy and local practice. Dr Dickey has published many scientific articles on various topics and is the author, most recently, of the Manual of Intrauterine Insemination and Ovulation Induction, published by Cambridge University Press in 2010.

“At FINO, we prefer to rely on a paradigm of fertility care based on the experience and input of our entire staff of clinicians.” —Mary M. MacGregor, RNC

fertility center, FINO’s assisted reproductive technologies (ART) staff consists of 5 physicians, 3 in vitro fertilization (IVF) nurse coordinators, a fertility laboratory director, and 2 embryologists. All these staff members have been with FINO for at least 10 years. The research and clinical experience of our 5 physicians combine to total more than 90 years of activity in fertility treatment and ART. We bring together perspectives from a multitude of institutions that are renowned for fertility treatment and research— Baylor University, Georgetown University, the Mayo Clinic, Ohio State University, and Tulane University. Our physicians’ individual special interests include IVF, intracytoplasmic sperm injection (ICSI), polycystic ovarian syndrome, fertility surgery, genetic analysis, preimplantation genetic diagnosis (PGD), pregnancy loss, and fertility preservation, to name a few. Richard P. Dickey, MD, PhD, who founded FINO in 1976, has been a major contributor to the fields of

What are the characteristics of the nurses at your clinic? FINO’s nursing staff has a minimum of 10 years of fertility experience per nurse. All 3 IVF nurse coordinators are certified in reproductive endocrinology and infertility, each with a minimum of 18 years of fertility experience. In addition, each of our IVF nurses currently holds a position on a pharmaceutical advisory board. Each office has a primary IVF nurse/third-party reproduction coordinator. Other nurses are responsible for working with physicians, cycling patients, and dealing with phone calls. FINO supports the 11 nurses on staff on a rotating basis by providing access to educational seminars, conferences, and symposia.

What is the approach to patient care at FINO? Our approach to patient care is as personally responsive as it is highly professional. It begins with a thorough evaluation and a precise diagnosis of the cause of the individual’s or the

Some Unique Features of FINO Over the years, we have achieved a number of milestones: • Establishing the first sperm bank in the Gulf South, 1982 • Performing the first IVF procedure in the Gulf South, 1983 (first birth, 1984) • Performing the first GIFT procedure in the Gulf South, 1985 • Achieving the first successful IVF pregnancy in a patient with a unicornuate uterus, 1987 • Achieving the first zygote intrafallopian transfer birth in the Gulf South, 1989

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• Achieving the first partial zona dissection birth in the Gulf South, 1993 • Achieving the first subzonal insertion birth in the Gulf South, 1994 • Achieving the first IVF pregnancy in the United States in a woman aged older than 44 years • Establishing the first frozen embryo program in the Gulf South • Achieving the first birth from an egg donation in the Gulf South • Achieving the first ICSI pregnancy in the Gulf South GIFT indicates gamete intrafallopian transfer.

Continued from page 1

couple’s infertility. We offer infertility treatment for men and for women at our clinic. No patient presenting at FINO is considered a routine case. The patient’s primary physician at the clinic makes all management decisions. Instead of a few standard IVF medicine protocols used at many fertility centers, we have identified a variety of optimal treatment regimens based on specific patient criteria, including: • Age • History of response to previous fertility treatment • Medical diagnosis • Presence of endometriosis or hormonal disorder • Quality of sperm • Risk for future multiple gestations. FINO treatment continues to evolve in the never-ending struggle for improved pregnancy rates and lower complication rates (such as multiple gestations and ovarian hyperstimulation syndrome). This has allowed us to develop effective treatment strategies— including medical treatments for hormonal disorders; surgical correction of physical impediments to conceiving; and aggressive treatment, such as IVF, for more severe conditions Beanie Welch, BS, causing infertili- MS, embryologist at FINO. ty—for virtually any fertility condition that can be encountered in a fertility center.

What are some of the typical services you offer? FINO opened its doors to a new “state-of-the-ART” in-office IVF laboratory in January 2009. Since 1977, our advanced fertility treatments have resulted in more than 10,000 births. As a team of specialists, we have proved our ability to diagnose and treat infertility. We offer a full range of infertility treatments, including nonsurgical treatment, microsurgery, laser surgery, artificial insemination, and ART, including IVF, micromanipulation of sperm and oocytes, PGD, and fertility cryopreservation. The physicians of FINO have earned their reputation for leadership in fertility medicine. In addition to our medical services, we offer 24-hour support service for patients to allay fears, concerns, medication issues, and general questions. We also offer monthly fertility support group meetings after hours, usually with guest speakers, such as acupuncturists, psychologists, social workers, medical doctors, grief counselors, and adoption agencies. Our patients can feel confident about the standing of our facilities in the medical community. We are a charter member of the IVF Registry and the Society of Assisted Reproductive Technologies, and our laboratory is certified by the College of American Pathologists. We have presented posters at meetings of the American Society of Reproductive Medicine (ASRM) and will present new posters and abstracts at the 2011 ASRM meeting. ■

Metabolic Markers May Predict Preeclampsia By Wayne Kuznar

etabolic profiling may soon be used in early pregnancy to predict which women are at risk for preeclampsia in later pregnancy. An international research team has identified 14 simple metabolites comprised of amino acids, carbohydrates, carnitines, phospholipids, and steroids that combined appear to be an accurate marker for the development of preeclampsia (Kenny LC, et al. Hypertension. 2010;56:741-749). The goal is to incorporate these metabolic markers into a single bedside blood test that will be inexpensive and accessible to hospitals. The first of 2 independent studies included 7000 women with first-time pregnancies; of these, 60 healthy

women later developed preeclampsia. They were matched with a control group of 60 women with uneventful pregnancies. The 14 metabolites were significantly elevated in the women who developed preeclampsia but not in the control group. The second study included nulliparous women in their early 20s who were ethnically more diverse than the predominantly white group in the earlier study. Of these women, 39 subsequently developed preeclampsia. They were matched with 40 controls. The same 14 metabolites again were elevated and increased the odds of developing preeclampsia. Single metabolites were not useful in predicting preeclampsia. ■

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Infertility Updates

They Called Him Noah...

a devastating time. More than 1800 people died, and 33,500 people were rescued by boat or helicopter. Some 300,000 people lost their homes. Many of FINO’s staff were included in that number and were waiting in far-flung

places, from Utah to New York City. The uncertainty about the future of the city and our practice was paralyzing. Landlines failed, cell phone towers did not work, and communication was only possible through text messaging and e-mail. Would the city come back? Would there be patients for us? Our office and IVF laboratory in the east were destroyed, along with thousands of patient records. The tanks of embryos were sitting on the third floor of the abandoned, flooded hospital. How would we possibly rescue them? This would require help from police with land and water transport capability in a city that was under martial law. On September 9, almost 2 weeks

Illinois Conservation Policeman and Louisiana State Trooper moving embryos to safety.

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after Katrina, help arrived in the form of a state representative with whom I was able to speak over the phone about our plight. Two days later, on September 11, our embryologist and I, along with 8 Illinois Conservation

“Our office and IVF laboratory in the east were destroyed, along with thousands of patient records. The tanks of embryos were sitting on the third floor of the abandoned, flooded hospital. How would we possibly rescue them?” —Sissy Sartor, MD

Photo courtesy of Fertility Institute of New Orleans.

frozen embryos were topped off with liquid nitrogen and evacuated to the third floor of the hospital in which the IVF laboratory was housed. This emergency evacuation of frozen embryos had been invoked 4 times since 1987, but the last catastrophic flooding associated with hurricanes had not occurred for 40 years. On Friday, August 26, 2005, Katrina was a category 1 hurricane that was not expected to hit Louisiana. When we went home for the weekend, the feeling was that it would be business as usual within a few days. Our evacuation plans reflected this mindset. The other FINO IVF facility (in west New Orleans) was in the middle of an active cycle, and although most patients opted to cancel their cycles and evacuate, 3 sets of embryos were in the incubator on the eve of Katrina. Tanks of cryopreserved embryos were topped off and evacuated to the third floor, and an embryologist remained at the facility so that embryos could be frozen or transferred after the storm passed. Katrina made landfall Monday at 6 AM, 90 miles southeast of New Orleans. By Monday afternoon, the storm surge had forced multiple levee, canal, and floodwall breaks. By Tuesday evening, 80% of the city was under water. Although the hospital in west New Orleans had generator power and did not flood, the hospital authorities closed the facility and asked all personnel to leave. Access back into the city was severely limited over the next 3 weeks. Although the violence and chaos that occurred after Katrina was significantly overblown by the media, it was

Continued from page 1

Police, 12 National Guardsmen and Louisiana State Policemen, and a commanding officer from the Louisiana State Police, were caravanning toward east New Orleans to the now-deserted hospital. In this caravan were 3 towed, large, flat-bottomed rescue boats and an army convoy truck. We were able to put boats into the water about three quarters of a mile from the hospital. The parking lot was filled with halfsubmerged vehicles. We entered the hospital through the gaping front door. The National Guardsmen, clad in waterproof hip boots, pulled the embryologist through the halls of the hospital in a small aluminum boat. They took the stairs to the third floor and then gently carried the 4 tanks of embryos down to the boats. We took them to the IVF laboratory in west New Orleans, where liquid nitrogen was added to the tanks. Finally, Noah had reached safety. On May 8, 2006, 2 embryos were thawed from Noah’s cohort. One embryo survived and was transferred the next day. Noah was born 9 months later, to great celebration. News media from all over the world were present, anxious to cover a note of grace from Katrina. A total of 28 pregnancies have occurred from the rescued embryos, 19 of them delivered or ongoing. FINO has not only survived, but has thrived. We have opened a new state-of-the-art IVF facility in west New Orleans, and we have seen a significant increase in the number of IVF cycles each year. Richard P. Dickey, MD, PhD, Medical Director and founding partner of FINO—one to never let a teaching moment go by—published our Katrina experience and recommendations for emergency preparedness for fertility

Preparing for Emergencies All IVF clinics should be prepared for catastrophic emergencies by: • Planning for safety of staff and patients • Preparing for loss of landlines and cell phones • Preparing for loss of electricity • Arranging to preserve clinic, patient, and embryo records • Providing patients with emergency instructions beforehand, including emails and phone numbers for the American Society of Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technologies (SART) • Arranging to continue patient care at another site, in case you are out of the clinic for weeks or months • Notifying ASRM/SART of your status

centers in Fertility and Sterility (2006;86:732-734). Changes to FINO’s hurricane plan based on Katrina include: • All embryos must be out of the incubator by the day of a storm • Last day for embryo retrieval is 3 days before a storm • Patients are informed at the start of hurricane season how to reach FINO or find another IVF clinic. ■

DID YOU KNOW…? According to the Centers for Disease Control and Prevention: • In the United States, about 3% of babies are born with birth defects; that’s 1 in every 33 babies. • The causes for about 70% of the birth defects are unknown. • Defects of the spine and brain affect about 1 in 1000 newborns. • Most birth defects happen in the first 3 months of pregnancy, when the organs of the baby are forming. • Heart defects make up about one-third to one-fourth of all birth defects. Source: www.cdc.gov.

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Infertility Updates ASRM HIGHLIGHTS

Why Age Matters: Medical, Psychological Aspects of Pregnancy in Older Age By Wayne Kuznar

any women are delaying childbearing to their late 30s and beyond, and this trend is expected to continue as more women pursue higher education and professional careers. The consequences of this decision are profound: it affects their chances of conceiving, their psychological well-being, and the lives of their future children, said infertility experts at the 2010 American Society for Reproductive Medicine meeting.

Role of Psychological Support A common mistaken belief is that in vitro fertilization (IVF) can reverse the effects of age, said Patricia Mendell, LCSW, MSW, counselor in private practice, New York City. Therefore, women must be educated early about their true chances of conceiving naturally or through IVF as they age. Providing psychological support for an older woman’s quest for parenthood is essential and requires sensitivity, she said. Some clinicians will say “‘if you can’t use your own eggs, you can use somebody else’s,’ without understanding or being respectful of the loss that people may feel when they can’t have that,” Ms Mendell said. Many IVF programs require a psychological consultation if a woman chooses to use donated gametes, but others only suggest that. Often, “when it’s only suggested, people don’t want to spend the money, or they feel that they know all there is to know,” she said. “But when they do come to see me, at the end of our discussion they are incredibly grateful that they came.” Other issues to consider when discussing donated gametes are the rights of the parents versus those of the offspring. “Is there the belief that a child has the right to information, or is there the belief that the parent trumps the right of any child to have information,” she said. “When you talk about a baby as an abstract concept, it’s easy, but when you have a growing-up child before you, the idea that they have a mind of their own as independent people makes it much more difficult.” You want couples to think about these things in the planning stages, she said. The impact of older first-time parents on their children also must be balanced with the individual’s right to procreate at any age. Although studies show few differences in the quality of parenting when children are aged <15 years, the impact in their 20s can be profound if they are orphaned or forced

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into the role of caretakers for aging, infirm parents, Ms Mendell said. Ovarian Reserve: Quality as Important as Quantity Several methods are available to determine ovarian reserve in older infertile women, said Margaret Garrisi, MD, Reproductive Endocrinologist, Institute for Reproductive Medicine and Science at St. Barnabas, Livingston, NJ.

in women of reproductive age.” AMH levels >0.7 ng/mL are normal, levels between 0.3 ng/mL and 0.7 ng/mL suggest borderline ovarian reserve, and levels at menopause are undetectable. Levels can be obtained at any day of the menstrual cycle, and the levels are not affected by pregnancy or oral contraceptive use. AMH levels strongly correlate with the number of oocytes retrieved during

“There is a dual aspect of a woman’s biological clock….The double whammy is the quality [of the oocytes], mainly due to chromosomal problems of older eggs, and aneuploidy.”—Margaret Garrisi, MD “There is a dual aspect of a woman’s biological clock….The double whammy is the quality [of the oocytes], mainly due to chromosomal problems of older eggs, and aneuploidy,” Dr Garrisi said. “Many women don’t understand that they don’t control this process.” Depending on the woman’s age, 30% to 80% of embryos are aneuploid, a major reason for IVF failure and miscarriage. Measurement of (day 3) basal follicle-stimulating hormone (FSH) levels is the most widely used indicator of ovarian reserve, but it is a late marker. “With an elevated FSH level, fewer oocytes are collected, and those that are collected have a higher rate of chromosomal abnormalities,” she said. To reduce false-negative results, she recommends also measuring estradiol levels when FSH levels are elevated, because high estradiol levels suppress FSH levels, which may result in normal readings when FSH levels are actually high. Antral follicle count is another method to assess ovarian reserve. It involves counting the number of follicles that are 2 mm to 10 mm by transvaginal ultrasound in the early follicular phase. A normal count is >10 antral follicles. The number of antral follicles may predict the response to stimulation in IVF cycles. Measurement of anti-Müllerian hormone (AMH) levels is a promising earlier indicator of ovarian reserve compared with measuring FSH levels and is only slightly more expensive, Dr Garrisi said. “AMH may be the earliest indicator of decline in ovarian reproductive function,” she said. “It may have the greatest power to predict ovarian aging

IVF and the chance of cycle cancellation because of poor response. Prediction of oocyte quality using AMH measurement is uncertain, however. The use of AMH measurement may also reveal occult polycystic ovarian syndrome and may warn of ovarian hyperstimulation, thus affecting the choice of gonadotropin dosage, she said. Screening Older Patients Medical screening requirements are extensive in older women undergoing egg donation, said Richard J. Paulson, MD, Professor of Clinical Obstetrics and Gynecology, and Medical Director, University of Southern California Fertility, Los Angeles. “Once you start pushing the age limit, and especially once you exceed a ‘natural’ age at which women get pregnant, then it becomes incumbent upon

Takeaway quick PoinTs ➤ Women must be educated about their true chances of conceiving naturally or through IVF as they age. ➤ Psychological support and psychosocial preconceptual consultation for older women are essential. ➤ The rights of the offspring must also be considered where donated gametes are concerned. ➤ Measuring anti-Müllerian hormone levels appears to be the earliest indicator of ovarian reserve. Tests for basal folliclestimulating hormone levels and estradiol levels should be conducted together to avoid false-negatives.

us to make sure that individual is healthy enough to carry a pregnancy,” Dr Paulson said. Although certain cardiac conditions and underlying vascular disease preclude an attempt at pregnancy, “it really comes down to a risk assessment, so that the patient can make an informed choice,” he said. The workup should begin with an assessment of general health status, to include a Pap smear, mammogram, blood chemistry, infectious disease screen, and a colonoscopy. Normal cardiovascular reserve should be present, as assessed by a stress treadmill test. The uterine cavity should be normal, as determined by hysterosalpingogram and hydrosonography, and the response to exogenous hormones should also be normal. Finally, a psychosocial preconceptual consultation is advised to assess the patient’s ability to handle parenthood at an advanced reproductive age and her attitude toward nongenetic parenting. As far as making the final call on the medical safety of a pregnancy in older age, “we think it should be up to the high-risk obstetricians, because we think they are the best ones to offer advice as far as the probability of issues, plus on top of that, they’re the doctors who are eventually taking care of the patient,” Dr Paulson said.

“We have drawn the line [for IVF] at age 54.” —Richard J. Paulson, MD

Dr Paulson and colleagues have studied obstetric outcomes after age 50 in women who conceived after IVF (JAMA. 2002;288:2320-2323). Results showed low neonatal birth weights for women delivering after age 50, and high rates of gestational diabetes (20%) and preeclampsia (35%) in this age-group compared with a 10% preeclampsia rate in women in their 40s. The preeclampsia rate climbs to 60% at age 55 or older. Although this case series included only 77 women, it is the largest study available, he said, and serves as the most reliable guidance. “We have drawn the line [for IVF] at age 54, due to the marked increase in preeclampsia and…diabetes,” Dr Paulson said. He said that although he performs IVF for women aged >50 years, “I write out that this baby would be better off in the uterus of a gestational surrogate.” ■

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Infertility Updates ASRM HIGHLIGHTS

Misoprostol Equal to Surgery in Resuming Fertility Treatment after Pregnancy Loss By Wayne Kuznar

ertility is restored after surgical management of a pregnancy loss at the same speed as with medical management, although a significant number of women who are managed medically have retained products of conception (POC), said Hilde Cotton, RN, BSN, a nurse at Reproductive Medicine Associates of New York, New York City, at the 2010 American Society for Reproductive Medicine meeting. Nurses fill a crucial counseling role after a pregnancy loss, she said. Couples often cite the compassionate care of the medical staff as having the greatest effect on their course of mourning. “Providers manifest this compassion in considering all options and aiding patients in making a decision based on their individual expectations,” she said.

days with surgical management. There were, however, marked differences between the groups for POC retention and karyotype results. A karyotype was obtained in 68% of the patients managed surgically and 5% of

those managed medically. Of the women managed with misoprostol, 26% retained POC compared with only 2% of those managed with D&C. “The study did not confirm the perceived benefit of faster return to fertil-

ity treatment for the D&C population,” Ms Cotton said. The data show that misoprostol is a viable option for patients undergoing fertility treatment, although a D&C is more likely to provide karyotyping. ■

“There was no significant difference between misoprostol and D&C in the time to treatment resumption.” —Hilde Cotton, RN, BSN

Pregnancy loss can delay the resumption of fertility treatment, and patients often ask what is the fastest, least-invasive, and easiest method to manage a missed abortion to resume fertility treatment. Each method has advantages and disadvantages. Surgical management, known as dilation and curettage (D&C), offers the chance to obtain a karyotype of the POC and is quick, but it requires anesthesia and carries the risk of infection and uterine scarring. Medical management with misoprostol avoids anesthesia, can be given at home if needed, and is less expensive than surgical management, but it involves the risks associated with retained POC, as well as painful uterine cramping. Ms Cotton and colleagues evaluated the effects of misoprostol compared with surgical management in the context of a pregnancy loss. Their study included 63 women who had a pregnancy loss before 10 weeks of gestation. The 19 women who were treated with misoprostol (800 mg vaginally) were compared with the 44 women who underwent D&C. “There was no significant difference between misoprostol and D&C in the time to treatment resumption,” Ms Cotton said. The time from treatment to the next fertility treatment cycle was 54.5 days with misoprostol and 60.3

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Ovarian Cancer? OVA1TM – the 1st FDA cleared blood test to help evaluate an ovarian mass for malignancy prior to a planned surgery.* Why OVA1? When used in conjunction with pre-surgical evaluation: t OVA1 provides objective information based upon the likelihood an adnexal mass is malignant or benign. t OVA1 can help physicians refer women to the most appropriate surgeons— potentially helping to promote better treatment outcomes. t OVA1 is available nationally through Quest Diagnostics. *FDA clearance does not denote official approval. OVA1™ is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. OVA1™ is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Vermillion and OVA1 are trademarks of Vermillion, Inc.

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Infertility Updates ASRM HIGHLIGHTS

Moderate Stress May Be Good... Israel Deaconess Medical Center, Boston. In her study of first-time IVF patients, the more distress they showed at baseline, the more likely they were to get pregnant. The study was designed to assess the effect of a mind/body program on IVF outcomes. As part of the study, she also looked at psychological distress in 97 women aged ≥40 years who underwent at least 1 IVF cycle. Of the women, 46 were randomized to the mind/body program and 51 were randomized to the control group. The mind/body program consisted of 10 sessions of relaxation techniques, multiple stress management strategies, instruction on appropriate lifestyle, and psychosocial support. The women were followed for up to 2 IVF cycles. All the women completed a battery of psychological tests at baseline (before cycle initiation), including the Beck Depression Inventory, the State-Trait Anxiety Inventory, and the Perceived Stress Scale. Across the entire study population, higher baseline scores for perceived stress and anxiety were associated with a greater chance of pregnancy. Among women randomized to the mind/body group, those who conceived had a mean

baseline score of 10.1 on the Beck Depression Inventory versus a score of 5.7 in the women who did not conceive (a score of 10-18 indicates mild depression; 0-9 indicates minimal depression).

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learned during the mind/body sessions had an impact on IVF outcome (scores on the Perceived Stress Scale range from 0-40, with higher scores indicating greater stress).

“Some distress prior to cycle initiation is beneficial, as long as patients have the skill to decrease their level of stress [during their cycle].” —Alice D. Domar, PhD

After cycle 2, the mind/body program did achieve a better pregnancy rate (52%) compared with the control group (20%). This improvement correlated with an increase in adherence to the program. During cycle 1, few women attended the sessions, and a pregnancy outcome was no more likely compared with the controls; however, in cycle 2, 76% attended 6 to 10 of the sessions. All those in the mind/body program who had a baseline score >20 on the Perceived Stress Scale conceived compared with only 57% of the control group, suggesting that coping skills

Mind/body patients who became pregnant had “startling” reductions in scales that measure anxiety and negativity and increases in scales that measure positivity, whereas the opposite was true in those who did not conceive, Dr Domar said. Previous research on the effects of stress on IVF outcomes have produced conflicting results, with most studies showing a negative impact from stress but others showing no relationship between stress and outcome. “It is possible that the discrepancy in research between distress and IVF out-

come is caused by differences in the timing of the psychological assessment,” said Dr Domar. Some studies evaluated stress before the cycle and some tracked stress as women went through the cycle. The way that stress is measured may also affect the association between stress and IVF outcome, said Robert Hunter, MD, Chief Resident, Obstetrics/ Gynecology, Staten Island University Hospital, NY. In his study, 217 women undergoing their first IVF cycle were asked to rate their infertility-related stress. Pregnancy rates and live birth rates were higher in women reporting greater levels of stress. “Our study reflects that there are different types of stress, some that decrease function and some that may improve function. We tried to simplify the way we model stress, down to just a simple question asking patients when they first came to us to rank their stress from 1 to 10 [as it relates to infertility], rather than using one of the more extensive questionnaires out there,” Dr Hunter said. “Some stress may be good stress. The next step will be to measure blood markers for stress and try to find out if these parallel what the patient is telling us in the questionnaire.” ■

Patients Not Absorbing Key Messages from Fertility Preservation Consultation

See also “The Cancer Patient,” pages 21-23.

By Wayne Kuznar

atients’ knowledge of fertility preservation treatment options is poor after an initial consultation, based on a survey of 27 women, said Ursula Balthazar, MD, fellow in the Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, University of North Carolina, Chapel Hill, at the 2010 American Society for Reproductive Medicine meeting. Knowledge increases, however, if patients bring someone with them to the consultation. “Overall, their knowledge of the content of the consultation was poorer than we thought, knowing about half of the questions,” Dr Balthazar said. New patients who received a comprehensive fertility preservation consultation were recruited to participate in a survey 3 to 12 months after the initial consultation. The 22-question survey assessed patients’ knowledge after the consultation. They were sent home with educational materials explaining how

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chemotherapy affects fertility; were referred to websites, such as www.fertile hope.org and www.myfertilitypreser vation.com; and had e-mail access to 2 physicians.

“Overall, their knowledge of the content of the consultation was poorer than we thought, knowing about half of the questions.” —Ursula Balthazar, MD

Based on their survey responses, only 26% of the patients knew that a woman with ovarian failure after cancer treatment could still become pregnant, and 56% thought that chemotherapy increased the risk for birth defects in future newborns. As expected, college-educated persons had higher scores; in addition,

“people who discussed their treatment options with someone else, and people who had a person present with them at the consultation had higher scores,” Dr Balthazar said. Also, patients who used the website recommendations (specifically www. fertilehope.org) had higher knowledge scores than those who did not. “Based on this study, we would recommend to our patients that they bring someone to the consult with them and talk about the consult at the end of it, because that increases their overall understanding of the material we presented in this model for fertility preservation consults,” she said. “In addition to using the same survey to measure knowledge scores after recommending that patients bring someone to the consult, we’re also going to create an educational tool for patients to look at in the waiting room before their consult to see if they had higher knowledge scores at the end,” Dr Balthazar added.

The study argues for more support systems, including access to nurses, as a means of increasing understanding, “given that…there’s such a short time for patients to absorb the material and make a decision,” she said. In addition, Dr Balthazar found that patients who used more support systems had fewer decisional conflicts, based on a validated decisional conflict scale. The scores of 10 of the 27 women indicated elevated decisional conflict. The factors that predicted more conflict were older age, fewer social support systems, not considering religious beliefs, not considering family’s wishes, perceived inadequate time to make a decision, and not receiving fertility preservation treatment. “Awareness of these factors may help fertility preservation providers and the oncology team decrease decisional conflict and stress for women presenting for fertility preservation consultation,” Dr Balthazar said. ■

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Infertility Updates AWHONN HIGHLIGHTS

In ART, Ethical Issues Still Thorny Nurses Focus on Multiembryo Transfer By Caroline Helwick

any complex ethical issues that have emerged with assisted reproductive technology (ART) are yet to be resolved. At the 2010 meeting of the Association of Women’s Health, Obstetric and Neonatal Nurses, the question of multiple embryo transfer was discussed in a session billed “No More Octomom!”

The Other Side of Justice Key ethical considerations revolve around autonomy, justice, and regulation, said Anita Catlin, DNSc, FNP, FAAN, Professor of Nursing and an Ethics Consultant at Sonoma State University, Rohnert Park, CA, noting that a “swinging pendulum” often determines how these play out in real life. “We hope that women who are making decisions for advanced reproductive technology have thought through these issues carefully,” Dr Catlin said. A patient considering ART must receive an explanation of the risks, consequences, benefits, and available alternatives in a language she understands, and must give consent without coercion or persuasion, she said. Although this type of informed consent is usually communicated, Dr Catlin has often found that “what patients hear and interpret is their dream and desire for a miracle— the possibility of having a baby.” “I’m not sure informed consent serves us in the way we want,” she said. For example, physicians undoubtedly have good judgment regarding the proper number of embryos to implant, but they often “yield to patient autonomy” in ways that do not reflect good judgment, she suggested. “Patient autonomy is not always the best thing.” Justice is also often lacking, she said. Justice requires an equal distribution of life’s goods, which takes into account need, effort, contribution, merit, and free market exchange, but consider the case of Nadya Suleman, who delivered 8 babies in January 2009, she added. For this “Octomom” to deliver her 8 infants, a staff of 46 was required, costing some $200,000, and the intensive care stay was estimated to range from $800,000 to $3 million. The hospital donated facilities and services. “Is everyone due the same? Is this available to every US citizen?” she asked. “I’m not sure this represents justice.” US Regulation Lagging Behind A 2006 Cochrane review of all available data for multiple gestations showed significant risks for morbidity and mortality to mother and infants,

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suggesting that regulation is needed and should be based on the patient’s age and the quality of the embryos. In response to this Cochrane review, Canada, England, and Sweden instituted strict regulations to prevent the “Octomom” scenario. “Not so in the United States,” Dr Catlin said. “We made recommendations, not regulations.”

and the National Perinatal Association are currently working on this issue. The Grief of Embryo Reduction Multifetal selective reduction is a procedure that brings great sadness to most expectant mothers, yet support for these women is largely lacking, Dr Catlin said.

“Nadya Suleman, a woman under 35, received 6 embryos, while she should have received 2. This was probably against the physician’s good judgment….Obviously, much work needs to be done on ethics related to multifetal gestation.” —Anita Catlin, DNSc, FNP, FAAN

The American Society for Reproductive Medicine issued the following recommendations for embryo transfer in 2008: • A limit of 2 embryos implanted for women aged <35 years • A limit of 3 embryos implanted for women aged 35 to 37 years • A limit of 4 embryos implanted for women aged 38 to 40 years • A limit of 5 embryos for women aged ≥40 years. Despite these recommendations, “in the United States, only 0.5% to 3% of all transfers are singletons,” Dr Catlin lamented. “We are ignoring the Cochrane suggestions in 97% of cases. Nadya Suleman, a woman under 35, received 6 embryos, while she should have received 2. This was probably against the physician’s good judgment, but patient autonomy won out.” “Obviously, much work needs to be done on ethics related to multifetal gestation,” she said. The American Congress of Obstetricians and Gynecologists

Multiple Gestations A study presented at the 2008 meeting of the American Society for Reproductive Medicine showed that 50% of infants from multiple gestations had health problems. The study also suggested that transferring more than 1 embryo improves pregnancy rates only slightly but dramatically increases the rate of multiple births (Macaluso M, Jeng G, Chang J. A low-hanging fruit: the benefits of promoting single embryo transfer to eligible patients). Source: www.cdc.gov.

Although the effects of reduction have not been well studied, studies do show that: • Few families are well-educated on the procedure and its consequences • Patients describe the procedure as traumatic, disturbing, and chaotic, and report feelings of depression, turmoil, and guilt • Grieving for the lost fetuses is compounded by the constant reminder of the viable fetuses or infants • Even with positive outcomes, negative feelings can emerge. “Families usually feel they made the right decision, but they report insufficient respect for their loss,” she explained. Their emotional state is one of “disenfranchised grief,” she said, or grief that is not openly acknowledged or

publicly mourned. Normal bereavement has aspects of ritual, religion/spirituality, family and friends, time allotted for grieving, emphasis on remembrance, cards/ flowers/foods, and so forth. In contrast, fetal reduction decisions are made in isolation, are not discussed even with close friends, and are subject to judgment from others. No time is allotted for grieving, and remembrance is shrouded in secrecy, she pointed out. Dr Catlin said that she could find no listings for multifetal reduction support groups and no mention of the topic on support websites for pregnancy loss. Multifetal reduction is absent from the 2003 seminal book, Motherhood Lost: A Feminist Account of Pregnancy Loss in

For this “Octomom” to deliver her 8 infants, a staff of 46 was required, costing some $200,000, and the intensive care stay was estimated to range from $800,000 to $3 million. America (by Linda Layne). In addition, funding organizations avoid the topic, because it is linked with the controversy of abortion. “This is clearly an area we need to work on, if we are going to have multiple gestations and ask this of our patients,” she said. ■

FDA Issues Warning for Sexual Enhancement Supplement

he US Food and Drug Administration (FDA) sent out a warning regarding TimeOut Capsules, a sexual enhancement product that contains a chemical similar to sildenafil, the active ingredient in Viagra. This chemical has the potential to lower blood pressure to dangerous levels, as well as interact with prescription drugs, especially nitrates. Despite the FDA’s acknowledgment that no adverse events resulting from the use of TimeOut Capsules had been reported at the time of this consumer alert, the product being labeled as “100% natural” by the manufacturer poses particular cause for concern. Such claims on the part of many manufacturers, particularly in the case of

so-called natural products that have not been properly or fully studied nor approved by the FDA, can give consumers a false sense of security about the safety of a product, the FDA stated. At the time of the warning, the FDA stated that TimeOut Capsules were still being sold via the Internet. Anyone who has experienced adverse effects from TimeOut Capsules is urged to seek medical care and discard the remaining product. In addition, healthcare providers or persons who have experienced adverse events are encouraged to report them to MedWatch, the FDA safety information and adverse event reporting program (1-800-FDA-1088; www.fda.gov/ medwatch). ■

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Women’s Health

Preventing Maternal Deaths...

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births; it was 9.1 for white women and 34.8 for non-Hispanic black women. This is an increase from 9.9 deaths in 1999, and double the 1982 rate, according to the National Center for Health Statistics. These numbers fall far short of the Healthy People 2010 goal of <3.3 maternal deaths per 100,000 live births and place the United States behind at least 40 other nations. “It’s safer to deliver a baby in Bosnia and Kuwait than in the United States, and we thought we had safety initiatives in place,” Ms Baird commented. Mortality Is Not the Only Problem Deaths are just a part of the problem. In 2004 and 2005, more than 68,000 American women “nearly died” in childbirth. “In other words, these were near misses,” she said. Problems frequently encountered in the delivery suite put many women at risk, including hypertension, preeclampsia, gestational and preexisting diabetes, asthma, and postpartum hemorrhage; 5% of women have preexisting medical conditions. Severe morbidity related to childbirth occurs in 50 women for every 1 maternal death. These complications include: • Transfusions (the most common) • Eclampsia • Hysterectomy • Cardiac events/procedures • Respiratory failure

The Safe Motherhood Quilt project (www.rememberthemothers.net) was started by Ina May Gaskin, CPM, MA, to honor women who have died as a result of childbirth complications. It was on display at the meeting.

• • • • • •

Complications of anesthesia Septicemia Mechanical ventilation Cerebrovascular accidents Acute renal failure Need for invasive hemodynamic monitoring • Obstetric shock • Pulmonary embolism. Unnecessary Interventions The high rates of morbidity and mor-

Table Early Warning Signs If the patient displays any of the following signs, call 1-1111 and request the rapid response team without delay, then call the patient’s primary team physician Changes in patient

Signs to watch for

Staff is concerned about patient

Patient does not look/act right Gut instinct that patient is beginning a downward spiral, even if no physiologic triggers have occurred

Change in patient’s respiratory rate

Respiratory rate is <8 or >30 breaths/min

Change in oxygenation

Pulse oximeter decreases to <90%

Labored breathing

Breathing becomes labored

Change in heart rate

Heart rate is <40 bpm or >120 bpm

Change in blood pressure

Onset of agitation/delirium

Systolic blood pressure is <90 mm Hg or >200 mm Hg Patient develops uncontrollable bleeding from any site/port Patient becomes somnolent, difficult to arouse, confused, obtunded Patient becomes agitated, delirious

Seizure

Signs of a seizure

Other alterations in consciousness

Any other changes in mental/CNS status: sudden blown pupil, onset of slurred speech, onset of unilateral limb/facial weakness

Hemorrhage Decreased level of consciousness

bmp indicates beats per minute; CNS, central nervous system. Source: The Vanderbilt Protocol.

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tality are at least partly a result of unnecessary interventions. In vaginal deliveries, the maternal death rate is 0.2 deaths per 100,000 live births; for cesarean deliveries, it is 2.2 per 100,000, according to a review by Clark and colleagues (Am J Obstet Gynecol. 2008;199: e1-e5. Epub 2008 May 2), who concluded that thromboembolism prophylaxis would greatly reduce this risk. In addition to cesarean sections, elective inductions and the use of Foley catheters contribute to the risk of maternal death. Early Warning Signs Maternal hemodynamics affects the outcome of the fetus and newborn, Ms Baird emphasized. Physiologic changes in pregnancy include increased heart rate, intravascular volume, stroke volume, oxygen consumption, and cardiac output; compensated respiratory alkalosis; and a hypercoagulable state.

“It’s safer to deliver a baby in Bosnia and Kuwait than in the United States.” —Suzanne McMurtry Baird, MSN, RN

Nurses should watch for risk factors, which include obesity, cardiac disease, hypertension, substance use, pulmonary embolism, amniotic fluid embolism, and obstetric hemorrhage. “Pregnant women can decompensate faster, and with standard signs we can miss this,” she noted. “The patient can become critically ill if we wait for symptoms to appear. The key is early recognition.”

Takeaway quick PoinTs ➤ Watch for the following maternal risk factors: amniotic fluid embolism, cardiac disease, hypertension, obesity, obstetric hemorrhage, pulmonary embolism, and substance use. ➤ Institutions should have protocols for when to call for additional help for a patient, and procedures for recognizing and responding to early warning signs. ➤ Warning signs include changes in vital signs, hemorrhage, seizure, or abnormal alterations in behavior or consciousness. ➤ Maternal hemodynamics affects outcomes. ➤ Schedule a follow-up home visit 6 weeks postpartum. The Joint Commission’s Sentinel Event Alert (Preventing maternal death. 2010;44) stipulates that centers should have a process for recognition and response as soon as a

“You want to recognize the early signs of compromise and promptly communicate this. Look for trends, not isolated signs, such as a decrease in urine output or change in vital signs.” —Suzanne McMurtry Baird, MSN, RN

patient’s condition worsens. In addition, there should be written criteria describing early warning signs of change or deterioration and indicating when to seek further assistance (Table). The rapid response team should be called first, and then the patient’s physician. “You want to recognize the early signs of compromise and promptly communicate this,” she said. “Look for trends, not isolated signs, such as a decrease in urine output or change in vital signs. You are the experts in physiological changes in pregnancy, so your input to the team is important.” Once the mother is discharged, ideally by 6 weeks postpartum, she should receive a home visit by a nurse who can assess the environment and evaluate for depression, infection, bleeding, and deep-vein thrombosis. “Many other countries provide this,” Ms Baird noted. ■

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Because patients trust your knowledge...

Progesterone # Fact 5 Only one progesterone is FDA approved for progesterone replacement. Itâ&#x20AC;&#x2122;s a fact. When patients are undergoing donor egg cycles, only CRINONE offers the confidence of FDA approval for progesterone replacement.1 In fact, CRINONE has demonstrated comparable pregnancy rates to IM P in a prospective, randomized trial of women in a donor egg cycle.2 When she asks about progesterone, give her the facts.

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

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Womenâ&#x20AC;&#x2122;s Health ASRM HIGHLIGHTS

Prenatal Medical Food Maintains Hemoglobin Levels in Pregnancy By Wayne Kuznar

esults of a recent study show that women who take a prenatal medical food containing L-methylfolate, high-dose vitamin B12, and iron (Neevo, NeevoDHA) during pregnancy are able to maintain higher hemoglobin levels than pregnant women taking a standard prenatal vitamin with iron

â&#x20AC;&#x153;The folic acid in a prenatal vitamin has to be metabolized, and some people are not able to fully metabolize it.â&#x20AC;? â&#x20AC;&#x201D;Amy Hermes, RN, WHNP-BC supplementation, folic acid, and lowdose vitamin B12, reported Amy Hermes, RN, WHNP-BC, Gainesville

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december 2010 I Vol 2, No 6

OB/GYN, TX. She reported the findings at the American Society for Reproductive Medicine 2010 Meeting.

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The American Congress of Obstetricians and Gynecologists has no specific definition of anemia during pregnancy, but most practitioners define it as a hemoglobin level <11 g/dL. Up to one third of women have hemoglobin levels <11 g/dL sometime in pregnancy. The prenatal medical food contains iron as well as 1 mg of L-methylfolate (the biologically active form of folate) and 1 Âľg of methylcobalamin (the active metabolized form of vitamin B12). â&#x20AC;&#x153;The folic acid in a prenatal vitamin has to be metabolized, and some people are not able to fully metabolize it,â&#x20AC;? said Ms Hermes. In this retrospective analysis, Ms Hermes compared the charts of 58 pregnant women who received the prenatal medical food and 54 pregnant women (all aged 21-39 years) who took a standard prenatal vitamin. Baseline hemoglobin levels and other patient characteristics were similar between the 2 groups. Hemoglobin levels were recorded at initiation of prenatal care, at the end of the second trimester, and at delivery. At the end of the second trimester, mean hemoglobin level was 11.8 g/dL in the group of women taking the prenatal medical food compared with 11.3 g/dL with the standard prenatal vitamin. Mean hemoglobin levels stayed higher in the women taking the prenatal medical food at delivery. Mean hemoglobin levels dropped 11% from initiation of prenatal care to delivery in women taking a standard prenatal vitamin and 4% in those taking the prenatal medical food. Anemia developed about half as often by 6 months in the prenatal food group compared with the prenatal vitamin group (39.7% vs 74.1%). Anemia has been linked to possible adverse pregnancy outcomes, such as miscarriage, preeclampsia, early delivery, and low birth weight, Ms Hermes said. â&#x20AC;&#x153;Hemoglobin levels greater than 11 g/dL are optimal and lessen the need for blood transfusion after delivery and other postpartum complications. Itâ&#x20AC;&#x2122;s possible that if we can reduce the risk of anemia and maintain patientsâ&#x20AC;&#x2122; hemoglobin levels, we may not have as many of those complications,â&#x20AC;? she said. â&#x20AC;&#x153;Standard practice in the past for women who become anemic had been to recheck their blood levels in the second trimester and give them an iron supplement. Our problem with that is that not all women are compliant, because of the gastrointestinal side effects, and it doesnâ&#x20AC;&#x2122;t work very well if youâ&#x20AC;&#x2122;re not able to take it. You could still add an iron supplement if they became anemic on the prenatal medical food, but we didnâ&#x20AC;&#x2122;t find the need to do so,â&#x20AC;? Ms Hermes said. â&#x2013;

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Women’s Health NAMS HIGHLIGHTS

Stopping Hormone Therapy Increases Hip Fracture Risk in Postmenopausal Women By Wayne Kuznar

ostmenopausal women who stop hormone therapy (HT) are more likely to fracture their hips than those who continue HT, said Roksana Karim, PhD, MBBS, Assistant Professor of Research, Departments of Pediatrics and Preventive Medicine, University of Southern California, Los Angeles. “Rising hip fracture risk in elderly postmenopausal women may be partially attributed to the continued decline in hormone therapy use. Hormone therapy–related benefits on hip fracture do not carry over after cessation,” she said at the 2010 meeting of the North American Menopause Society. “Women at risk of hip fracture should consider carefully before making a decision to stop hormone therapy.” Prescriptions for HT dropped by almost 50% shortly after publication of the results from the Women’s Health Initiative in 2002. To assess the effect of abrupt HT discontinuation on hip fracture risk, Dr

Karim conducted a longitudinal observational study of 80,955 postmenopausal women aged ≥60 years (mean age, 69 years), who were enrolled in any of the 11 Southern California Kaiser Permanente Medical Centers and had filled at least 1 prescription for HT.

“Women at risk of hip fracture should consider carefully before making a decision to stop hormone therapy.” —Roksana Karim, PhD, MBBS

Between July 2002 and December 2008, the hip fracture rate increased from 3.9% to 5.7%—totaling 1419 hip fractures, while the prescription rate for HT dropped from 85% to 18%, Dr Karim said.

After adjusting for age and race, women who did not receive HT in the previous years had a 55% greater risk for hip fracture compared with those who continued using HT. Assessment of hip fracture risk based on the number of years not receiving HT since 2002 showed a significantly increased risk of hip fracture with ≥2 years of not receiving HT. Bone mineral density (BMD) was inversely related to the number of years not using HT. In the group of women who never stopped HT, average BMD on dual-energy x-ray absorptiometry scan was –1.24, whereas the average BMD was –1.88 among the women who had stopped for 5 or more years. “These results have economic and public health implications,” Dr Karim said. “The estimated annual cost of osteoporotic fracture in the US is $18 billion, and hip fracture results in greater cost and disability than all other fractures combined.”

Takeaway quick PoinTs ➤ Prescriptions for HT dropped by almost 50% after the Women’s Health Initiative, which may partly explain the increase in hip fractures in older women. ➤ Elderly women who stop using HT are more likely to have hip fracture than those who continue using hormones. The risk increases with ≥2 years of not using HT. ➤ In addition, the risk of mortality in this age-group increases by 6-fold within 3 months of hip fracture. ➤ The annual cost of osteoporotic fractures is about $18 billion; hip fractures are associated with greater costs and disability than all other fractures combined. The risk of mortality also increases 6-fold within 3 months of hip fracture, she noted, a risk that increases further with time. ■

Bone Density Scans Too Often Ordered Inappropriately Treatment of Women at Risk for Fracture Is Suboptimal

linicians often fail to follow screening guidelines for osteoporosis, which can lead to inappropriate treatment, investigators from the Reading Hospital and Medical Center, PA, reported at the 2010 meeting of the North American Menopause Society (NAMS). They examined 615 women aged >49 years who were referred for dualenergy x-ray absorptiometry (DXA) screening. Of the women who were sent for DXA, 41.3% did not meet the criteria for such screening, according to 2006 NAMS guidelines. “Overutilization of DXA testing is of concern, as some patients not meeting criteria will occasionally yield abnormal test results,” said the investigators, led by Melissa Dubois, MD, Resident in Obstetrics and Gynecology at the Reading Hospital. These results may contribute to inappropriate treatment and unnecessary cost, worry, visits, and testing. All women were referred for screening and therefore judged to be at risk for osteoporosis, but 25.5% of them were not taking calcium, 31.1% were not taking vitamin D, and almost 60% were not exercising as recommended (0.5-2 hours weekly). “Many women at the highest risk of fracture are not receiving proper treat-

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ment,” the researchers stated. Even among the women who previously had a fracture, 13.3% were not taking calcium and/or vitamin D, 76.9% were not exercising as recommended, and 33% were not taking osteoporosis medications (ie, bisphosphonate, raloxifene, or calcitonin).

“The ones at the highest risk were least likely to come back for scans.” —Lynn Pattimakiel, MD

Other women who met the criteria for treatment based on their T-score (between –2 and –2.5) and risk factors were also not being treated appropriately; 20.5% were not taking calcium, 23.1% were not taking vitamin D, 55.6% were not exercising the recommended amount, and 27.1% were not receiving therapy. Of the women who did not meet the criteria for treatment, 17.8% were prescribed a bisphosphonate, raloxifene, or calcitonin. According to the authors, this practice raises concerns about longterm therapy with antiresorptive agents given the lack of long-term safety data with these agents.

Another study presented at the meeting by researchers from the Cleveland Clinic showed that adherence to bone mineral density (BMD) follow-up scans was poor in postmenopausal women, especially in those who were at an increased risk for fracture. “The ones at the highest risk were least likely to come back for scans,” said lead researcher Lynn Pattimakiel, MD, a second-year fellow. This study included 1956 patients who received a total of 2222 DXA

scans; results showed that those with osteoporosis were 28% less likely to have follow-up scans than those with “normal” T-scores (–1.0 or higher). The oldest patients (≥80 years) were half as likely to have follow-up scans as younger women (aged 50-54 years). “Some of these women may already have been using drug treatment for low BMD or osteoporosis, but they still need to be followed,” Dr Pattimakiel said. The reasons for not returning for DXA scans were not assessed.—WK ■

B12 Status Can Make or Break Alzheimer’s Risk Whether individuals have a sufficient intake of vitamin B12 can mean the difference between developing Alzheimer’s disease (AD) and avoiding the malady, recent research has shown (Hooshmand B, et al. Neurology. 2010;75:1408-1414). Investigators studied the effects of serum levels of homocysteine (tHcy) and holotranscobalamin (holoTC)— the active fraction of vitamin B12— on the development of AD in older Finnish persons (aged 65-79 years) without dementia. Of the 271 men and women in this

study, 17 developed AD during the 7year study. Persons who developed AD had, among other factors, increased tHcy levels and reduced holoTC levels compared with their counterparts who did not develop AD. For each 1-pmol/L increase in baseline holoTC levels, AD risk was reduced by 2%; for each 1-μmol/L increase in tHcy levels, the risk for AD increased by 16%. The researchers noted that these results show that the role of B12 in AD development warrants further investigation. ■

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Women’s Health AWHONN HIGHLIGHTS

Do Not Ignore the Risks for Late-Preterm Newborns By Caroline Helwick

ate-preterm infants are at risk for a host of problems and are often discharged from the hospital too soon, said Barbara Medoff-Cooper, PhD, CRNP, FAAN, RN, the Ruth M. Colket Professor in Pediatric Nursing and Director, Center for Biobehavioral Research, University of Pennsylvania School of Nursing, Philadelphia. The key concerns are thermoregulation, respiratory distress, jaundice/hyperbilirubinemia, and feeding issues. “We should keep these infants longer. As a nurse practitioner, this was one of my battles with neonatologists and insurance companies, but I wound up losing the battle, because there were no policies in place to support me,” Dr Medoff-Cooper told nurses at the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) 2010 meeting. AWHONN was the first organization to initiate a conversation about this issue to improve the quality of care for these infants. In 2005, AWHONN launched a multiyear initiative to raise awareness of these risks and develop evidence-based guidelines. Increased Morbidity and Mortality Rates More than 9% of all births in the United States, or 377,000 infants, are born between 34 and 36 weeks, the late-preterm period. The mortality rate at this period is tripled—to 9.3 deaths per 100,000 births—compared with 2.5 deaths per 100,000 births for full-term

Takeaway quick PoinTs ➤ More than 9% of all infants in the United States are born between 34 and 36 weeks. ➤ The mortality rate for these infants is tripled compared with full-term infants. ➤ Despite their appearance, these newborns are physiologically immature, resulting in thermoregulation problems, respiratory distress, jaundice/hyperbilirubinemia, and gastrointestinal/ feeding problems. ➤ Consider the perinatal history and risk factors, as well as the type of delivery, closely monitor body temperature and watch for hypothermia and hypoglycemia, evaluate the infant’s ability to breastfeed and quality of the feedings, and assess for weight loss and dehydration.

december 2010 I Vol 2, No 6

infants. Neonatal respiratory morbidity is 4.4 times greater, neonatal infections are 5.2 times greater, and mean hospital stay is 142 hours longer for late-preterm infants than for term infants, she said.

resuscitation). Nurses should try to minimize cold stress, which increases oxygen consumption. The risk for abnormal thermoregulation is greatest during the first few hours

“The problem is that size, appearance, and initial stability at delivery often result in normal newborn care. They often look like healthy full-term kids, and this fools you.” —Barbara Medoff-Cooper, PhD, CRNP, FAAN, RN

“The problem is that size, appearance, and initial stability at delivery often result in normal newborn care,” Dr Medoff-Cooper said. “They often look like healthy full-term kids, and this fools you.” These newborns may be physiologically immature in terms of control of lung volume, laryngeal reflexes, upper airway, and coordination of suckswallow-breathe functions. Their clinical risks are primarily related to organ immaturity and include cardiopulmonary problems, such as respiratory distress syndrome; gastrointestinal problems and feeding issues; inadequate brain development; and jaundice and hyperbilirubinemia. In addition, late-preterm infants are at increased risk for hypoglycemia, temperature instability, signs resulting in a sepsis workup, conditions requiring intravenous lines, and apnea and bradycardia. They are likely to require intensive care, especially those born at 35 weeks (54%) and 34 weeks (88%). Proper Clinical Assessment Is Critical Clinical assessment is critical to identifying these infants and preventing problems. The first step is to do an accurate gestational age assessment using standardized tools, because “these babies may be more immature than they appear,” Dr Medoff-Cooper emphasized. This provides more accurate data for the newborn risk assessment. The younger the gestational age, the higher the risk for respiratory distress. In evaluating for respiratory distress syndrome, nurses should consider the perinatal history and risk factors, type of delivery, and factors related to the immediate transition to extrauterine life (ie, Apgar score, need for oxygen or

of birth because of heat loss. Nurses should closely monitor body temperature and watch for hypothermia and hypoglycemia. Supplemental heat sources are often necessary to minimize heat loss and properly insulate these infants, she said. “Throughout the hospital stay, you should monitor the newborn’s ability to maintain body temperature in the open crib,” she said. Thermoregulation should be normal before hospital discharge. Jaundice and hyperbilirubinemia are concerns, because of the risk for brain injury. Risk factors include gestational age <36 weeks, asphyxia, acidosis, sepsis, poor feeding, hemolytic disease, lethargy, and temperature instability. Breastfeeding infants are particularly at risk, and hyperbilirubinemia in these infants can be prolonged.

“Do a feeding assessment and measure bilirubin levels in any infant with jaundice,” Dr Medoff-Cooper advised, adding that a nomogram of hour-specific serum total bilirubin concentration is helpful. “Do not rely on visual assessment and interpret all bilirubin levels in terms of infant’s age in hours. A bilirubin over 18 mg/dL should require a rapid response.” Feeding Issues Common breastfeeding problems are magnified in late-preterm infants, including decreased ability to latch on, difficulty in getting to an alert state, increased risk of hyperbilirubinemia, increased weight loss in the first days/weeks after birth, and maternal difficulty in establishing a milk supply. “Late-preterm infants should not be expected to feed like a full-term infant on the first days of life,” she said. “They have decreased stamina, which results in less effective suckling and breast stimulation, and their suckswallow-breathe cycle may not be fully developed. Delay discharge if feeding is suboptimal.” Dr Medoff-Cooper recommended getting the baby to the breast within the first hour of birth if possible, and maintaining continuous skin-to-skin contact (avoiding separation from the mother). Nurses should evaluate the infant’s ability to breastfeed on demand, monitor the quality of the feedings, and assess for weight loss and dehydration. “Also, it’s important to educate the mother about behavioral state and early feeding cues,” she said. ■

Laparoscopic Hysterectomy Fast and Safe By Rosemary Frei, MSc

aparoscopic hysterectomy can and should replace open hysterectomy for benign gynecologic conditions, according to 2 gynecologic surgeons. “There’s no reason that most hysterectomies for benign pathologies should be done as open procedures,” Rick L. Heaton, MD, President of the Heart of Georgia Women’s Center, Warner Robins, told the OB/GYN & Infertility Nurse-NP/PA. “Nurses should encourage patients to seek treatment by advanced laparoscopic surgeons for their gynecological surgery needs, because open surgery is hardly ever needed for

benign gynecological surgery.” As proof, Dr Heaton and M. Sami Walid, MD, research fellow at the Medical Center of Central Georgia, Macon, proffer a study of Dr Heaton’s extensive record with laparoscopic hysterectomies (Heaton RL, et al. An intention-to-treat study of total laparoscopic hysterectomy. Int J Gynaecol Obstet. 2010;111:57-61). Of 639 hysterectomies Dr Heaton performed between March 2003 and December 2009, all but 5 were laparoscopic. Dr Walid noted in his analysis of Dr Heaton’s procedures that the average operative time for typical total laparoContinued on page 17

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Women’s Health

Early Labor Detector May Offer Enhanced Outcomes By Rosemary Frei, MSc

team of young physicians and inventors in Baltimore, MD, is taking baby steps toward perfecting a device designed to detect early labor. The inventors of the silicone ring equipped with sensors to pick up contraction-associated electrical signals in the uterus are all recent graduates of the Center for Bioengineering Innovation and Design master’s program at Johns Hopkins University. They created the concept for the detector during the year-long program. Several members of that team have now formed CervoCheck, LLC, and moved it into a startup incubator at Johns Hopkins’ Eastern campus. Animal testing of the device is currently under way as the first step toward human use. The only early labor detector that is commercially available—the tocodynamometer—can occasionally pick up contractions in early gestation but usually only in thin women, explained

The CervoCheck team.

“We’d like to prevent those awful outcomes at 24 to 26 weeks, when the fetuses are just at the cusp of survival.” —Abimbola Aina-Mumuney, MD

Abimbola Aina-Mumuney, MD, Assistant Professor, Division of Maternal– Fetal Medicine, Department of Gyne-

cology & Obstetrics, Johns Hopkins School of Medicine, and CervoCheck’s medical officer. The obesity crisis cries out for a detector capable of working in heavier women, Dr Aina-Mumuney said. Dr Aina-Mumuney nudged the students in the direction of creating an internal device that would detect preterm labor very early in pregnancy or in obese women. “We have made some modifications to our initial design, making it more flexible so that the obstetrician can insert it [into the pregnant woman’s vagina] more easily,” Karin Hwang, MSc, the device’s co-inventor and a principal of CervoCheck, told the OB/GYN & Infertility Nurse-NP/PA. “I’m excited about this device, because the main thing is to try and

prevent a lot of wastage of pregnancy in the middle trimester—in cases when we don’t otherwise know they are contracting and so don’t try to stop labor and delivery,” Dr Aina-Mumuney said. “We’d like to prevent those awful outcomes at 24 to 26 weeks, when the

The silicone ring early labor detector.

fetuses are just at the cusp of survival. And this will also allow us to intervene and prolong pregnancies, at whatever stage early labor is detected.” ■

H1N1 Flu in Pregnancy Poses a Serious Risk to Mother, Fetus By Jessica A. Smith

he H1N1 influenza virus puts pregnant women and their fetuses at risk for a number of obstetric complications, including fetal distress, premature delivery, emergency cesarean delivery, and fetal death, according to a recent observational study of 18 pregnant women (aged 18-40) who had the H1N1 flu, in 2 academic medical centers (Arch Intern Med. 2010;170:868-873). Participants were identified as having H1N1 through direct antigen testing (DAT) of nasopharyngeal swabs, as well as real-time reverse transcriptase polymerase chain reaction (rRT-PCR) analysis or viral culture. The researchers compared information regarding patient demographics, symptoms, hospital course, laboratory and radiographic results, pregnancy outcome, and placental pathologic information with published reports on the H1N1 virus and reports of flu pandemics in 1918 and 1957. Of the 18 women, 2 were healthcare workers (11%), 15 were black (83%), 2 were Hispanic (11%), and 1 was nonHispanic white (6%). None reported recent travel. The most prevalent comorbidities were asthma, sickle-cell anemia, and diabetes. All the women were treated with oseltamivir phosphate beginning on the day they were admitted to the hospital. Mean hospital stay was 4 days, and 3

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women were admitted to the intensive care unit (ICU). Half of the patients presented with gastrointestinal or abdominal issues, and 72% (n = 13) met sepsis criteria.

The H1N1 flu vaccine is readily available today and is recommended for the majority of pregnant women. With initial or repeated DAT, 14 of the patients tested positive for H1N1 and 4 were identified as positive through viral culture or rRT-PCR. During the hospitalization period, 7 women delivered, with 6 delivering prematurely (gestational age <37 weeks). Of those who delivered prematurely, 5 involved fetal distress and 4 were emergency cesarean deliveries. No congenital birth defects were identified among the neonates. There were 2 cases of spontaneous abortion and fetal death; both occurred at a gestational age <23 weeks; in addition, 1 woman was admitted to the ICU for a first-trimester miscarriage. No maternal mortality occurred. “H1N1 poses a serious threat to pregnant patients,” the researchers wrote. “In addition to respiratory complaints,

many pregnant patients with H1N1 presented with gastrointestinal complaints. Direct antigen testing is not sufficiently sensitive to diagnose influenza in pregnant patients presenting with an ILI [influenza-like illness]. If a high

index of suspicion exists, patients should be empirically treated with antiviral agents,” they wrote. The H1N1 flu vaccine is readily available today and is recommended for the majority of pregnant women. ■

Laparoscopic Hysterectomy... Continued from page 16 scopic hysterectomies declined from 98 minutes at the beginning of the study to 59 minutes at the end. The average time for the last 57 laparoscopically-assisted vaginal hysterectomies (LAVHs) was 93 minutes. The average blood loss, drop in hemoglobin and hematocrit, operative time, and length of hospital stay also were significantly lower with total laparoscopic hysterectomies compared with LAVHs. Of 14 total laparoscopic hysterectomy cases with intraoperative organ injuries, 13 were repaired intraoperatively, including 3 that were not related to the total laparoscopic hysterectomy technique. Postoperatively, 47 vaginal cuff infections occurred. The investigators calculated that the average hospital cost was $12,514 for total abdominal hysterectomies and $13,468 for total laparoscopic hysterectomies.

“Knowing that hysterectomy rates are highest in women aged 40 to 44 years, at the peak of their productive lives, we emphasize the economic advantage of laparoscopic hysterectomy from shorter convalescence periods and earlier return to work,” they wrote.

“There’s no reason that most hysterectomies for benign pathologies should be done as open procedures.” —Rick Heaton, MD

However, Drs Walid and Heaton found that only 55% of hysterectomy procedures performed by OB/GYN residents across the United States are laparoscopic, and that the average vaginal-to-abdominal hysterectomy quotient is 0.50. ■

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CONTINUING EDUCATION

WWW.OBGYN-INFERTILITY-NURSE.COM

PROGRAM CNE003 • RELEASE DATE: DECEMBER 20, 2010 • EXPIRATION DATE: DECEMBER 20, 2011 ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Genetic Counseling: Family History Risk Assessment Sarah Keilman, MS, CGC; Eric Czuprenski, BS; Rosanne Keep, MS, CGC Ms Keilman is a Certified Genetic Counselor and Mr Czuprenski is a Molecular Biologist, Genesis Genetics Institute, Detroit, MI; Ms Keep is a Certified Genetic Counselor, Abington Reproductive Medicine, PA

sTaTeMenT oF neeD The family history is the most important tool for diagnosis and risk assessment in medical genetics. Taking a detailed family history for people planning to have a child is a useful tool for identifying individuals who may carry a risk for a genetic disorder, and it can improve the medical care of these patients. The detailed family history allows clinicians and other healthcare professionals to identify patients who may benefit from predictive genetic testing. Many women and men do not find out that they are at high risk for having a child who may be affected with a genetic disease until the woman is already pregnant or after delivery. Finding a potential genetic disease in the family history during pregnancy can add a significant level of anxiety to the pregnancy that could have been avoided with preconception genetic counseling. Such an assessment is often not conducted in the primary care setting. TaRGeT auDience Nurses whose primary interest is women’s health and infertility. LeaRninG oBJecTiVes After completing this activity, the reader should be able to: • Describe patient-associated risk factors that may contribute to the potential of a genetic disease • Discuss the key genetic factors that increase the risk for a genetic disease in the context of family planning • Review the patterns of inheritance in human genetics that can affect specific diseases, such as cystic fibrosis, hemophilia, and neural tube defect • Describe the role of family history in the risk for Huntington disease and breast or ovarian cancer conTinuinG nuRsinG eDucaTion accReDiTaTion anD conTacT HouRs sTaTeMenT Science Care is approved by the California Board of Registered Nursing, Provider number 15559, for 1.0 contact hour. MeTHoD oF PaRTiciPaTion 1. Read the article in its entirety 2. Go to www.obgyn-infertility-nurse. com 3. Select “Continuing Education” 4. Click on this article’s title from the list shown

december 2010 I Vol 2, No 6

ecent advances in the understanding of the human genome have led to increased knowledge and awareness of genetics and inherited diseases. These developments have enhanced the interest in using family history as a model for targeting individuals who are at greater risk for familial (ie, genetic) diseases. The Significance of the Genetic Link Taking a detailed family history is a useful tool for identifying individuals who may need further consultation, and it can improve the medical care of these patients.1 Such detailed family history also allows clinicians and other healthcare professionals to identify patients who may benefit from predictive genetic testing. Rich and colleagues indicate that the family history is the most important tool for diagnosis and risk assessment in medical genetics, and that a family history promises to serve as a critical element in primary care medicine.2 When an individual is planning to start a family, there are benefits to knowing her/his family history before conception. Many women and men do not find out that they are at high risk for having a child who may be affected with a genetic disease until the woman is already pregnant or after delivery. Finding a potential genetic disease in the family history during pregnancy can

5. Select “Click here to complete the posttest and obtain a CE certificate online” 6. Complete and submit the CE posttest and CE activity evaluation 7. Print your Certificate of Credit This activity is provided free of charge to participants. FacuLTy DiscLosuRes As a provider accredited by the California Board of Registered Nursing, Science Care must ensure balance, independence, objectivity, and scientific rigor in all its activities. All course directors, faculty, planners, and any other individual in a position to control the content of this educational activity are required to disclose to the audience any relevant financial relationships with any commercial interest. Science Care must determine if the faculty’s relationships may influence the educational content with regard to exposition or conclusion and resolve any conflicts of interest prior to the commencement of the

Table 1 Patterns of Inheritance in Human Genetics Inheritance pattern

Definition

Disease example

Autosomal dominant 1 affected gene copy is all that is needed to cause disease

Retinoblastoma

Autosomal recessive

2 affected gene copies are necessary to Cystic fibrosis cause disease 1 affected gene copy results in a carrier of the condition

X-linked dominant

A dominant genetic mutation is carried on the X chromosome

Rett syndrome

X-linked recessive

1 affected gene copy on the X chromosome will affect males, but females will be carriers

Hemophilia

Multifactorial

Caused by environmental factors as well as mutations in multiple genes

Neural tube defects

add a significant level of anxiety to the pregnancy that could have been avoided with preconception genetic counseling. A detailed review of the family history before pregnancy enables us to educate patients about potential risks and additional reproductive options that may be available. Key Factors A number of important factors must be considered when taking a detailed family history in the context of family planning. These include: 1. A patient’s pregnancy history: Multiple miscarriages can indicate a chromosomal abnormality, whereas certain preeducational activity. Disclosures are as follows: • Eric Czuprenski, BS, has nothing to disclose. • Rosanne Keep, MS, CGC, has nothing to disclose. • Sarah Keilman, MS, CGC, has nothing to disclose. • Harvey J. Stern, MD, PhD, has nothing to disclose. • Dalia Buffery, MA, ABD, has nothing to disclose. • The staff members of Science Care have nothing to disclose. DiscLaiMeR The opinions and recommendations expressed by faculty, authors, and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of Science Care or Novellus Healthcare Communications, LLC. COPYRIGHT STATEMENT Copyright © 2010 Science Care. All rights reserved.

natal ultrasound findings can indicate other inherited conditions3 2. The degree of relatedness: If a patient has a sister affected with an inherited disease, there is a higher risk to the patient than if the affected individual was a first cousin3 3. Full or half sibling status: Half siblings share only 25% of their DNA, whereas full siblings share 50% of their DNA3 4. Modes of inheritance: Table 1 outlines the common inheritance patterns and provides examples for these 5. Consanguinity: If a woman and her partner are first cousins, there is an increase in risk for adverse outcomes in pregnancy compared with a couple that eDiToRiaL BoaRD eric czuprenski, Bs Molecular Biologist Genesis Genetics Institute 5555 Conner, Suite 1100 Detroit, MI 48213 Rosanne keep, Ms, cGc Certified Genetic Counselor Abington Reproductive Medicine 1245 Highland Avenue, Suite 404 Abington, PA 19001 sarah keilman, Ms, cGc Certified Genetic Counselor Genesis Genetics Institute 5555 Conner, Suite 1100 Detroit, MI 48213 Debra Moynihan, wHnP-Bc, Msn Nurse Practitioner, Women’s Health Clinical Director, Carolina OB/GYN 242 Willow Bay Drive, Murrells Inlet, SC 29576 Harvey J. stern, MD, PhD Director, Reproductive Genetics Genetics & IVF Institute 3015 Williams Drive Fairfax, VA 22031

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is not blood related; the widely accepted risk in the general population of malformations in a pregnancy is between 3% and 4%; the risk to second cousins and beyond is statistically similar to the risk of an unrelated couple (Table 2).4,5 Examples of Challenging Diagnoses In addition to accurately interpreting family history and risk for inherited conditions, genetic counselors also discuss the benefits and limitations of relevant genetic testing options and help patients to understand and adapt to the implications of inherited diseases. Genetic counselors specialize in many areas of medicine, including oncology, pediatrics, and obstetrics.

Case 1A A 29-year-old woman is contemplating starting a family. Taking a detailed family history is essential in her risk assessment. When asked about her par-

Figure 1 No Significant Family History Mother

Father

Died young Partner Patient 29 years old

Unaffected male Unaffected female Deceased individual

ents’ health, she states that her father is in good health, but that her mother died very young in a car accident. By gathering data only from the patient’s first-degree relatives, the patient would appear to have no significant health risks (Figure 1). As we go further into the family history, however, more information is discovered that suggests potential genetic risks, as can be seen in Case 1B below. Case 1B A 29-year-old woman is contemplating starting a family. Taking a detailed family history is essential in her risk assessment. When asked about her parents’ health, she states that her father is in good health, but her mother died very young in a car accident. When asked about her mother’s parents, she states that her mother’s father is affected with Huntington disease, as are 2 of her maternal uncles. Her mother might have had the Huntington disease mutation, but because she died young, she did not live long enough to display symptoms.3 Figure 2 demonstrates the role of family history in Huntington disease. It is clear from Case 1B that by obtaining a thorough family history, health risks to the patient become apparent. If information on each grandparent was not requested, this woman might never have realized that she was at risk for Huntington disease. It would be important to refer this woman to a genetic counselor, so that she could be properly counseled on her potential risk for Huntington disease and the options for testing. As she gets older, her risk for developing symptoms increases, and a proper diagnosis could be instrumental to her treatment.

Figure 2 Family History of Huntington Disease

Table 2 Risk of Malformations in Couples of Varying Degrees of Relatedness Degree of relation

First cousins

Not related

Risk, %

Up to 6.8

3-4

Source: Bennett RL, Motulsky AG, Bittles A, et al. Genetic counseling and screening of consanguineous couples and their offspring: recommendations of the National Society of Genetic Counselors. J Genet Couns. 2002;11:97-119.

This patient also has a number of reproductive options. She may choose to have her children soon. She may choose to be tested for the condition before having a family, or she may even choose to use preimplantation genetic diagnosis to reduce the risk of transferring this disease to her children.

in interpreting family and medical histories to assess the risk for disease. Case 2 A 32-year-old woman presents to her gynecologist for her annual checkup. She reports that since her last appointment, her mother has been diagnosed with breast cancer at age 52 years. Because of the possibility of inherited breast cancer, her gynecologist asks about any other cancer diagnoses in other family members. The patient reports that her maternal aunt had ovarian cancer at age 52 years, and her maternal grandmother had breast cancer at age 70 years. Given this family history, the patient’s physician refers her to a genetic counselor to discuss the possibility that this history is indicative of hereditary breast and ovarian cancer syndrome, as shown in Figure 3. Before their scheduled appointment, the genetic counselor was able to obtain medical records from the patient’s mother, maternal aunt, and maternal grandmother. A detailed review of this information makes it apparent that the maternal aunt did not have ovarian cancer. Instead, she had cervical cancer. In addition, because this patient has not had a blood relative diagnosed with breast cancer before the age of 50 and has no family history of ovarian

If information on each grandparent was not requested, this woman might never have realized that she was at risk for Huntington disease. If a detailed family history had not been taken, the patient might not have realized that she was at risk for a progressive disease. With more information obtained about a family, more of an accurate assessment can be made for a patient’s risk of inherited conditions. Such a detailed family history is often not obtained in primary care and obstetric settings. Any healthcare provider can obtain a patient’s family history; however, accurately interpreting that history can be challenging. When a family history is significant for an inherited or suspected condition, it is appropriate to refer the patient to a genetic counselor, who has specialized training

Continued on page 20

Figure 3 Family History of Breast and Ovarian Cancer Maternal grandfather

Father

Maternal grandfather

Maternal grandmother

Diagnosed at age 55

Died of cancer at age 85

Uncle

Mother

Maternal grandmother

Diagnosed at age 70

Father

Uncle

Maternal aunt

Mother

? Died young

Diagnosed at age 53

Diagnosed at age 60

Partner

Diagnosed at age 52

Partner Patient 29 years old

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Patient Unaffected male Unaffected female Affected individual Deceased individual

32 years old

Unaffected male Unaffected female Affected with breast cancer Affected with ovarian cancer

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COMMENTARY

Understanding Reproductive Genetics Harvey J. Stern, MD, PhD Director, Reproductive Genetics Genetics & IVF Institute, Fairfax, VA

eproductive genetics has become an intrinsic part of helping couples who are undergoing assisted reproductive technologies (ART). As in general obstetrics, couples attempting to achieve pregnancy through in vitro fertilization (IVF) or other ART procedures need to be made aware of their potential genetic risks. An individual’s genetic liability is composed of disease-related genetic traits accumulated from their ethnic background and unique family history. Population statistics estimate that the average healthy person carries 5 to 8 gene alterations associated with recessive genetic disorders.1 Even when the carrier is healthy, family planning and reproduction can be risky. If the reproductive partner happens to carry a gene alteration for one of the genetic conditions, the pregnancy would be at risk for a child with that disease.

Prenatal genetic counseling is a process by which couples are advised of potential genetic liabilities; the probability of a fetus developing a disease; and ways the disease may be prevented, avoided, or ameliorated in the offspring. The 2 procedures used to obtain a more accurate assessment of genetic liability are a detailed assessment of the family history and appropriate prenatal genetic testing. During a genetic counseling session, patients are asked questions about their personal and medical history, as well as questions about the medical history of siblings, parents, cousins, and grandparents, to obtain complete information on 3 generations. After assessment of this core family group, obtaining information on additional family members may provide a deeper understanding of familial patterns. Anything suggesting potential genetic disorders or other noted risks is then

Genetic Counseling... Continued from page 19 cancer, she is not considered to be at increased risk for hereditary breast or ovarian cancer. Frank and colleagues found that a woman with this family history has a 1.5% risk of having a genetic mutation involving the BRCA1 or BRCA2 gene.6 If more information for this patient reveals cancer diagnoses in the family, a reevaluation would be appropriate. Advances in the Understanding of Heritable Diseases The advancements made in our understanding of the human genome have led to greater understanding in the progression of heritable diseases. The creation of a family pedigree has become the model for visualizing and interpreting familial diseases (Figures 1-3). A detailed family history can help healthcare professionals to determine when genetic testing is appropriate for the individual patient.3 Documenting a family history also provides a starting point for medical intervention for an entire family.7 It allows for referral to appropriate specialists, where the patients can obtain information that can help them make informed choices about their health and the health of their future children.

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Conclusion Factors to consider when taking a family history in the context of human reproduction include previous pregnancies, degree of relatedness between the woman and her partner, genetic relationship to affected family members, mode of inheritance, and consanguinity. If a patient is at high risk for a hereditary disease, she or he should be referred to a genetic counselor. If healthcare professionals place a greater emphasis on this component of patient consultation, we will be able to provide more comprehensive care for patients and their families. ■

discussed in detail. Couples are educated about their risks for recurrence of a disorder and early warning signs, and are counseled about the emotional, social, and familial implications of the identified risks. With a basic under-

Population statistics estimate that the average healthy person carries 5 to 8 gene alterations associated with recessive genetic disorders. standing of the various options, couples can then have control over how or if they pursue further information. Many times, couples elect specific genetic testing to gather more information. The American College of Obstetricians and Gynecologists has issued standard recommendations for ethnic and general population genetic screening in couples of reproductive age.2 Testing is available for more than 2000 genetic disorders, including common diseases, such as sickle-cell anemia, cystic fibrosis, and spinal muscular atrophy, or more complex conditions, such as mental retardation or congenital heart disease.

The family history (ie, pedigree) is the mainstay of reproductive genetic risk assessment. The cases discussed in the main article demonstrate that failure to take an accurate 3-generation pedigree can lead to missing important information regarding the couple’s true risk for genetic disease in their offspring. Many IVF centers and even some OB/GYN practices now employ genetic counselors who are experts in obtaining and interpreting genetic risk information. Tools to help collect family history are widely available; the Centers for Disease Control and Prevention has compiled a list that includes resources from the US Surgeon General, the Genetic Alliance, and the American Medical Association.3 If genetic risk factors are identified, or if the patient has concerns regarding potential risks for the offspring, referral to a geneticist or genetic counselor is appropriate. ■ References 1. Milunsky A, Milunsky JM. Genetic counseling: preconception, prenatal and perinatal. In: Milunsky A, Milunsky JM, eds. Genetic Disorders and the Fetus: Diagnosis, Prevention and Treatment. Wiley-Blackwell: Oxford, UK; 2010. 2. Committee on Ethics, American College of Obstetricians and Gynecologists; Committee on Genetics, American College of Obstetricians and Gynecologists. ACOG Committee Opinion no. 410: ethical issues in genetic testing. Obstet Gynecol. 2008;111:1495-1502. 3. Centers for Disease Control and Prevention. Family history collection tools. 2009. www.cdc.gov/genomics/fam history/resources/tools.html. Accessed October 25, 2010.

References

1. Acton RT, Go RC, Roseman JM. Genetics and cardiovascular disease. Ethn Dis. 2004;14:S2-8-S2-16. 2. Rich EC, Burke W, Heaton CJ, et al. Reconsidering the family history in primary care. J Gen Intern Med. 2004;19:273-280. 3. Scheuner MT, Wang SJ, Raffel LJ, et al. Family history: a comprehensive genetic risk assessment method for the chronic conditions of adulthood. Am J Med Genet. 1997;71:315-324. 4. Zlotogora J, Shalev SA. The consequences of consanguinity on the rates of malformations and major medical conditions at birth and in early childhood in inbred populations. Am J Med Genet A. 2010;152A: 2023-2028. 5. Bennett RL, Motulsky AG, Bittles A, et al. Genetic counseling and screening of consanguineous couples and their offspring: recommendations of the National Society of Genetic Counselors. J Genet Couns. 2002; 11:97-119. 6. Frank TS, Deffenbaugh AM, Reid JE, et al. Clinical characteristics of individuals with germline mutations in BRCA1 and BRCA2: analysis of 10,000 individuals. J Clin Oncol. 2002;20:1480-1490. 7. Hunt SC, Gwinn M, Adams TD. Family history assessment: strategies for prevention of cardiovascular disease. Am J Prev Med. 2003;24:136-141.

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The Cancer Patient ESMO CONFERENCE NEWS

Breastfeeding Safe in Breast Cancer Survivors By Alice Goodman

reast cancer survivors should be counseled that it is safe for them to breastfeed their babies, according to the results of a small study presented at the 2010 European Society of Medical Oncology (ESMO) Congress. This study is the second by the same group to show that breastfeeding is safe in breast cancer survivors, explained lead author Hatem Azim, MD, Department of Medical Oncology, Jules Bordet Institute, Brussels, Belgium. “Thus far, there is no negative evidence and fears are unfounded. Breast cancer survivors should not be denied the opportunity to breastfeed their babies,” he stated. Breastfeeding has benefits for both mother and baby. For the baby, breastfeeding reduces the risk of infections, diseases, and allergies, and leads to improved cognitive and neuropsychological development. For the mother, breastfeeding promotes bonding with the baby, facilitates postpartum weight loss, helps control postpartum bleeding, stimulates uterine contractions back to the pelvis, and normalizes blood glucose in women who develop gestational diabetes. This 4-year study included 20 women; median age was 32 years at cancer diagnosis and 36 years at delivery. A total of 10 women opted to breastfeed and 9 opted not to breastfeed, because their physicians counseled against it. “This finding emphasizes the need for proper counseling of these women,” Dr Azim said. “Although I acknowledge that available evidence to support breastfeeding is not strong, there is no evidence for a detrimental effect.” Among the women who breastfed, 4 stopped within 1 month and 6 had long-term success. The ability to breastfeed over the long-term was associated with the type of breast surgery and postdelivery lactation counseling. Women who had breast-conserving surgery were more likely to breastfeed successfully compared with those who had a mastec-

tomy, which was probably related to body image, he suggested. Most of the women who breastfed used only the unaffected breast. Breastfeeding with the affected breast was challenging, because of hypoplasia and hypotrophia, along with reduced milk production from the hypotrophic breast. Also, latching onto the nipple of the affected breast was difficult.

“Thus far, there is no negative evidence and fears are unfounded. Breast cancer survivors should not be denied the opportunity to breastfeed their babies.” —Hatem Azim, MD “These women need motivation and encouragement to face their fears regarding their history of breast cancer

and the effect on milk production, fetal health, and of course, risk of recurrence,” Dr Azim said. ■

CONTINUING EDUCATION CREDITS Current activities at www.COEXM.com include:

Takeaway quick PoinTs ➤ This is a second, although small, study by the same group to show that breastfeeding in breast cancer survivors is safe. ➤ Almost 50% of the women opted not to breastfeed, based on their physician’s counseling. ➤ There is no evidence against breastfeeding for breast cancer survivors; although the evidence to support it is not strong, counseling women based on the evidence is important.

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The Cancer Patient ESMO CONFERENCE NEWS

Fertility Concerns of Cancer Survivors Require More Attention By Alice Goodman

mproved cancer treatment outcomes in young cancer survivors and a trend in the general population to delay having children have made fertility concerns a growing problem, said Bogda Koczwara, BM, Professor and Head, Department of Medical Oncology, Flinders Medical Centre, Adelaide, Australia, at the 2010 European Society of Medical Oncology (ESMO) Congress. “We were prompted to conduct our study because millions of people worldwide are living after treatment for cancer, many of them of reproductive age,” she said. “The most intriguing finding was that fertility concerns were also identified by women who have already completed their families, and fertility was an important issue even for those women who had no plans for additional children.” This suggests that fertility is important for some patients’ sense of identity and body image. “Doctors may not raise fertility issues for patients who state that they are finished having children, but this study points out that

maybe we should be discussing this with patients,” she said. The study was based on interviews with 25 cancer survivors—19 women and 6 men. A trainee psychologist conducted the interviews and audiotaped them; transcripts were reviewed to identify emergent themes.

“Doctors may not raise fertility issues for patients who state that they are finished having children, but this study points out that maybe we should be discussing this with patients.” —Bogda Koczwara, BM

The median age of survivors was 38 years (range, 24-50 years). The median time from completion of cancer treatment was 7 months (range, 2-62 months). Of the women, 14 were breast

cancer survivors, 3 had lymphoma, 1 had a germ cell tumor, and 1 had ovarian cancer. Among the men, 3 had testicular cancer, 2 had lymphoma, and 1 had Langerhans cell histiocytosis. Fertility emerged as a theme of universal importance to participants, regardless of their desire for children in the future. Among the participants, 5 were distressed about their perceived inability to have more children, 9 female participants who had decided not to have children before treatment were upset when they learned that fertility could be affected by treatment, and 2 women who had decided not to have children said that the loss of fertility had a negative impact on their feminine identity. At the time of the interview, 16 patients did not know their fertility status, yet 5 of these people believed that they were infertile. The following views represent concerns raised by participants regarding cancer treatment–related misinformation and decisions that could result in infertility: • 7 patients were in “survival mode”

when they agreed to treatment, and fertility seemed like a minor issue at the time • 5 patients realized that they would face potential infertility only after treatment was started • 10 patients were not sufficiently informed about the potential effect of treatment on fertility • 5 patients did not remember discussing fertility with their doctors before commencing treatment • 4 patients had no idea whether fertility resources existed and where they could access them. The interviews also focused on sexuality. Important cancer-related themes that emerged from the interviews included negative body image, negative impact on relationships, and reduced sex drive. Patients also expressed feeling that they received little information or support regarding the impact of cancer and its treatment on sexuality, underscoring the need for strategies to provide information and support to cancer patients regarding both fertility and sexuality. ■

ASCO BREAST CANCER SYMPOSIUM NEWS

Clinicians Ignore Sexuality Problems in Breast Cancer Survivors

“50% to 90% of breast cancer survivors report [sexual] concerns….We hear things like, ‘I’m thankful to be alive but I am dead down there!’ and ‘Breast cancer contributed to the deterioration of my marriage.’”

By Caroline Helwick

he majority of breast cancer survivors report some alteration, often profound, in sexual drive or pleasure. Not enough is known about the optimal treatment approach to restore sexual health to these women. In fact, sexual health concerns are often ignored in the primary care and oncology settings. To help our readers address these important issues with their patients who have survived breast cancer, the OB/GYN & Infertility NurseNP/PA talked with Michael L. Krychman, MD, Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine, and Medical Director of Sexual Medicine, Hoag Memorial Presbyterian Hospital, Newport Beach, CA.

How big is the problem of sexual dysfunction in breast cancer survivors? Dr Krychman: If you are not seeing sexual health issues in your oncology practice, you are not asking the right

questions, because 50% to 90% of breast cancer survivors report concerns even many years after diagnosis. We hear things like, “I’m thankful to be alive but I am dead down there!” and “Breast cancer contributed to the deterioration of my marriage.” Simple interventions can help.

How do you define female sexual dysfunction? Dr Krychman: Female sexual dysfunction is a persistent or recurrent problem; it causes “marked distress” or “interpersonal difficulty,” and is not accounted for by another axis I disorder or exclusively a result of the direct physiological effects of a substance (eg, medication) or general medical condition. Complaints often overlap, including sexual desire disorders, sexual arousal disorders, dyspareunia, orgasmic disorder, and vaginismus. Usually you have to tease out the main issue. For example, patients may report lack of desire, but you discover they have

—Michael L. Krychman, MD

severe vaginal atrophy associated with aromatase inhibitors, so naturally they are not interested in sex.

What are the main medical sexual issues in breast cancer survivors? Dr Krychman: Many problems are the result of lowered estrogen levels that can produce urogenital and vulvovaginal changes, such as vaginal dryness and irritation, increased malodorous discharge, and vulvar discomfort. Vaginal atrophy can lead to dyspareunia and distress, even during a pelvic examination. Decreased vaginal length,

lubrication, and secretions can cause problems with intercourse. Loss of vaginal mucosal tone can also lead to genitourinary complaints. Hot flashes can interfere with sexual health. Negative body perceptions as a result of surgery affect many women. Altogether, this is a huge quality-of-life issue, and it is not just about sex.

Once you have broached the topic, what should be the next step? Dr Krychman: First, you help the patient focus on “the new norm” and forget about “goal-oriented sex” (ie, Continued next page

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The Cancer Patient Clinicians Ignore Sexuality Problems... penetration, with orgasm and sexual release as the goal). In the field of sexual health, we instruct couples to focus on pleasure rather than performance. As for products, we try to stay away from estrogen as much as possible. Vaginal atrophy can sometimes be effectively treated with vaginal moisturizers (eg, Replens or vaginally applied vitamin E) and dilators. Mindfulness-based sex therapy has been shown to significantly improve response and reduce sexual distress, and acupuncture is emerging as a means of treating hot flashes. I have also found that testosterone helps some patients. Bupropion may help women with coexisting mood disorder and sexual dysfunction. For sexual dysfunction associated with antidepressants, long-acting sildenafil can be effective. Some women like Zestra essential arousal oils, which is a blend of botanical oils and extracts topically applied to the genital area to enhance sensitivity. I usually suggest that patients try these nonhormonal approaches first.

In your opinion, what are the best lubricants and moisturizers? Dr Krychman: I prefer the more natural products, such as parabens and propylene glycol, because they have fewer additives. For lubricants, I recommend Good Clean Love and HydraSmooth, which can be ordered online. For moisturizers, Feminease and Moist Again are good choices. Replens is backed by clinical trial data, but patients need to understand that it should be used twice weekly and can take up to 2 months to work. Colors,

Takeaway quick PoinTs ➤ When breast cancer survivors report a lack of desire, there is usually an underlying medical reason to be teased out. ➤ Many problems are the result of lowered estrogen levels that can produce urogenital and vulvovaginal changes, such as vaginal dryness, irritation, and vulvar discomfort. ➤ Nonhormonal products and techniques, including vaginal moisturizers, dilators, and other natural products are effective first-line options. ➤ If nonhormonal options do not work, minimally absorbed local vaginal estrogen products can be useful. But be aware that all forms of estrogen are absorbed to some extent.

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Continued from page 22

warming gels, flavors, bactericides, and spermicides should be avoided.

Can breast cancer survivors safely use the low-estrogen products? Dr Krychman: We like to avoid estrogen as much as possible. If an “aggressive conservative” nonhormonal approach is not enough, patients can try the minimally absorbed local vaginal estrogen products, such as the estradiol vaginal ring (Estring), conjugated equine estrogen cream (Premarin, Estrace), and the ultralow-dose 10-µg tablet (Vagifem), which used to be 25 µg of 17-beta estradiol but is now available only in the lower dose. But be aware that all forms of estrogen are absorbed to some extent. Even local vaginal treatments may increase serum

Are there newer treatments that may be more helpful and less potentially harmful?

phy and exerts relatively potent beneficial effects on sexual function, but it does not appear to increase serum sex steroid levels (Labrie F, et al. Menopause. 2009;16:897-906;907-922;923-931). Also, the novel 5-HT(1A) agonist/5HT(2A) antagonist flibanserin is currently under US Food and Drug Administration review for the treatment of hypoactive sexual desire disorder, based on promising clinical trial data (Clayton AH, et al. Womens Health (Lond Engl). 2010;6:639-653). ■

Dr Krychman: Yes; I am really excited about new data on the daily use of intravaginal DHEA (dehydroepiandrosterone) ovules (Prasterone), which is in phase 3 trials. It provides androgenic/estrogenic stimulation over several vaginal layers and thus improves atro-

Dr Krychman is the author of 100 Questions and Answers About Life after Breast Cancer: Sensuality, Sexuality, Intimacy, and 100 Questions and Answers for Women Living with Cancer: A Practical Guide for Survival.

estradiol levels, and the effects may not be limited to the vagina. In a recent study of women who used Vagifem or Premarin cream for 7 days, serum estradiol increased 5-fold within 24 hours of application (Labrie F, et al. Menopause. 2009;16:30-36). Some patients may need a combination of products, 1 external and 1 intravaginal, for relief.

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Nutrition AWHONN HIGHLIGHTS

Helping Your Patients Eat Right to Stay Healthy Nutrition Expert Busts Common Myths By Caroline Helwick

colon cancer. In other studies, high vitamin D levels were protective against colon cancer.

What is the latest consensus about dietary fat?

“The current consensus is that percent of fat intake is not related to breast cancer, although animal fat—but not vegetable fat—is.”

lthough it is a stretch to say that you are what you eat, food choices do impact major health outcomes. At the Association of Women’s Health, Obstetric and Neonatal Nurses 2010 meeting, Carlos A. Camargo, MD, DrPH, an expert from the Harvard School of Public Health, Boston, provided answers regarding the latest findings on diet and health, many of them based on the Nurses’ Health Study (NHS) I and II.

Dr Camargo: Nothing is fundamentally bad about fat. In fact, polyunsaturated fat is good for you. Heart disease rates can be dramatically reduced by nutritional means but not by replacing saturated fat with carbohydrates, which was once the recommendation. We should abandon recommendations about percent of energy from fat and avoid pejorative references to “fatty foods.” Instead, we should focus on replacing saturated and trans fats with vegetable oil, including sources of omega-3 fatty acids (eg, fish, some vegetables).

—Carlos A. Camargo, MD, DrPH

In general, contrary to what is often heard, a diet high in fruits and vegetables is not protective against cancer, although we should eat frequent servings (especially green and dark orange vegetables) because of their nutritional value.

How is alcohol intake good or bad? Dr Camargo: Moderate intake of alcohol (ie, 2 drinks per day) reduces heart disease risk, especially when folate intake is high. Folate also helps mitigate the increase in breast cancer risk associated with alcohol intake. With low daily intake of folate (<150 µg/dL), ≥2 drinks raises breast cancer risk by 40%, but with daily folate intake of 600 µg/dL, this risk disappears.

Modifiable Risk Factors for Optimal Health The following modifiable diet and lifestyle risk factors minimize the risk of heart disease, type 2 diabetes, and perhaps colon cancer. Regretfully, only 3% to 4% of the US population fit this profile: • Nonsmoker • Body mass index <25 kg/m2 • Brisk daily exercise for ≥30 minutes • Good diet: low trans fat, high polyunsaturated:saturated fat ratio, low glycemic load, high cereal fiber, high fish intake, high total folate intake • Limited red meat: ≤2 weekly servings • Moderate alcohol intake, preferably with folic acid supplementation for women

What is the best diet for weight loss? Dr Camargo: The universal concept of “eat fat and be fat” is probably not true. A low-fat diet is not more helpful for weight loss. A traditional low-carbohydrate diet may produce quicker

How does diet influence the development of cancer? Dr Camargo: The current consensus is that percent of fat intake is not related to breast cancer, although animal fat—but not vegetable fat—is. In the NHS II, women consuming the most animal fat had a 60% increased risk of breast cancer compared with persons with diets high in plant oils. In the NHS I, high consumption of red meat (>5 servings per week) was associated with an almost 3-fold risk for

weight loss, but this advantage is lost over time, and this diet often leads to a higher intake of protein and animal fat, which can have adverse outcomes. A low-carbohydrate/high–animal fat diet is associated with a 40% increased risk for heart disease, whereas a low-carbohydrate/high–vegetable fat diet is associated with a 40% reduction in risk. The type of diet is not important. People simply need to reduce calories and stick with it.

Can diet help prevent fractures? Dr Camargo: There is no evidence that drinking milk as an adult will help prevent fractures; however, a daily intake of 800 IU of vitamin D from foods high in beta-carotene and sunlight exposure does appear protective. Calcium supplements are an effective substitute for dietary calcium.

How can diet affect the development of type 2 diabetes?

Food pyramid for health.

Dr Camargo: The NHS II showed that high consumption of sugar-sweetened beverages is associated with greater weight gain and increased risk for type 2 diabetes. Even 1 sugar-sweetened soft drink per day conveyed an 83% risk of type 2 diabetes.

Whole fiber, however, is protective. It effects insulin release (lowers the glycemic load) and therefore lowers the risk for type 2 diabetes and probably for heart disease. This applies to pregnant women, who are more likely to develop gestational diabetes when their diets are high in glycemic load and low cereal fiber. This combination produced a 2.15-fold increased risk in NHS II. We are finding that the majority of type 2 diabetes cases could be prevented through healthy lifestyles. In NHS I, 91% of new cases of type 2 diabetes were attributed to unhealthy behaviors, such as lack of exercise, poor diet, smoking, and increased alcohol intake, even after adjusting for high body mass index. ■

Supplements Claiming to Be Black Cohosh Often Are Not By Wayne Kuznar

ore than 25% of herbal supplements labeled as black cohosh contain none of the herb, according to research presented at the 2010 North American Menopause Society meeting. Using DNA barcoding, David A. Baker, MD, Professor, Department of Obstetrics, Gynecology, and Reproductive Medicine at the State University of New York, Stony Brook, and colleagues found that 27% of samples from products marketed as black cohosh (Actaea racemosa) “had absolutely no black cohosh in them at

december 2010 I Vol 2, No 6

all, but instead contained a plant from China that’s used as an ornamental plant in the garden,” he said. Black cohosh is taken by many women for the purpose of treating menopausal symptoms. It is a member of the Actaea species but is often confused with other plants of the genus Actaea, some of which can be toxic, resulting in muscle and vascular damage. “There are plants that are toxic to humans, and so my study suggests that substitution and misidentification may be indeed the prime reason there have been toxicities reported with black

cohosh. Black cohosh that’s identified as black cohosh appears to be safe,” Dr Baker said. Identifying plant materials can be difficult, because they are often ground to a fine powder or extracted, wiping out morphologic traits. Barcoding is the use of DNA sequences to identify specimens across all of life, similar to the use of UPC codes on commercial products. The researchers extracted DNA from 26 dietary supplements. The 7 products that contained no black cohosh contained an Asian species of

Actaea; A racemosa does not occur naturally outside of eastern North America. For this reason, an honest identification error is not likely in products that are adulterated with Asian species of Actaea, Dr Baker said. The study demonstrates that regulation of the herbal supplement industry is possible, he said. “It really states that…the industry and the regulators have a way of making sure that the consumer is safe and getting what they indeed want to take, and what really is on the label is in that plastic white bottle.” ■

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OBGYN_1210_OBGYN 12/14/10 10:51 AM Page 25

Join the Academy at

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

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

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

CLINIC PRO FILE

Fertility Preser Focus of Ferti vation the lity Institute

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

EMERGING QUESTIONS

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

Will HPV Scree the Pap Smea ning Replace r?

Experts Debate the

By Caroline Helwi ck

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

CLINIC SPO TLIGHT

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

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

Safety of VTE Pregnant Wo Prophylaxis in men Varies

Continued on page

By Wayne Kuzna r

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

The Offic Offical ialPubli Publicatio cationnofof

•

for issues such as coverage and reimbursement.

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

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

Inside

Continuing Educ Reproductive Depre ation ssions

Page 10

Nurse Perspective: Postpartum Depression

Page 12

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

Pros and Con s

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

Pharmacy Corn Infertility Medicationer Storage

Page 19

Legal Matters For Clinicians Deali ng with Gestational Carri ers

Page 20

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

Page 26

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

OBGYN_1210_OBGYN 12/14/10 10:51 AM Page 26

Men’s Health SUNA HIGHLIGHTS

Should We Really Be Using PSA? Nurses Debate the Pros and Cons By Neil Canavan

t the 2010 Society of Urologic Nurses and Associates meeting in Boston, 2 urology nurses debated the pros and cons of using prostate-specific antigen (PSA) screening in older men for early diagnosis of prostate cancer. The data relevant to this question come from 2 recently published large randomized trials.

The Case for PSA Screening The case for widespread screening— led by the desire to do something to reduce the high rates of prostate cancer incidence—was presented by Silvia S. Maxwell, MSN, ACNP-BC, CUNP, Certified Urology Nurse Practitioner, Detroit Receiving Hospital, MI, who advanced her argument by presenting the scope of the problem. “The National Cancer Institute estimates that 217,730 new cases will be diagnosed in 2010, eventually resulting in over 32,000 deaths,” Ms Maxwell said. As most healthcare providers know, the earlier a cancer is detected the better the treatment outcome, “and right now, the PSA test is our primary tool in the early detection of these prostate cancers,” she added.

directly responsible for the percentage of the decline is not clear, because of the concurrent advances in treatment options. Nevertheless, it was apparent that for that initiation period, prostate cancer was overdiagnosed. “This can be attributed to the fact that there is no universally accepted cut-off PSA threshold (generally held to be around 4 ng/mL),” Ms Maxwell said. Furthermore, an elevated PSA level may not be related to prostate cancer; increased levels may be indicative of infection or inflammation, urethral trauma, recent ejaculation, or a recent digital rectal examination (which should therefore be performed after PSA, not before). By contrast, PSA levels may be artificially depressed from antibiotics use, the use of finasteride or dutasteride (for benign prostatic hyperplasia), or when a patient’s body mass index (BMI) is high (ie, BMI ≥35 kg/m2). To have relevance, PSA testing must help in diagnosing tumors in their early stages, when the cancer tends to remain localized. The 5-year survival rate for localized cancer is close to 100%; for metastatic disease, it drops to 32% for

“The National Cancer Institute estimates that 217,730 new cases will be diagnosed in 2010, eventually resulting in over 32,000 deaths….The problem is that while PSA is specific for prostate, it is not specific for cancer.” —Silvia S. Maxwell, MSN, ACNP-BC, CUNP Therein lies the debate: 2 recent, large trials—the Prostate, Lung, Colorectal and Ovarian Cancer Screening (Andriole GL, et al. N Engl J Med. 2009; 360:1310-1319), and the European Randomized Study of Screening for Prostate Cancer (Schröder FH, et al, for the ERSPC investigators. N Engl J Med. 2009;360:1320-1328)—that had combined enrollment of more than 200,000 men, did not definitively show that PSA testing saves lives based on widespread screening. “The problem is that while PSA is specific for prostate, it is not specific for cancer,” Ms Maxwell said. First identified as a prostate marker in 1966, PSA was established as a tumor marker in 1979 and approved as a diagnostic test in 1994. After the introduction of the test, there was marked increase in prostate cancer detection and a 30% decline in prostate cancer– related deaths. However, whether the test was

december 2010 I Vol 2, No 6

white men and 29% for black men. “African Americans have the highest rates in the world,” Ms Maxwell said. Other risk factors include age ≥65 years, family history, and <12 years of formal education. Although prostate cancer is a serious concern, the question remains whether PSA testing provides information that justifies all the biopsies performed. “I do believe that over the years, many men have been overtreated,” Ms Maxwell said, suggesting that clinicians should explain the meaning of a PSA score to men. “A value of 2 or 2.5 indicates a very slow-growing tumor, of very little eventual risk.” This is particularly true of the elderly. The Evidence Is Inconclusive Susanne A. Quallich, MSN, ANPBC, NP-C, CUNP, Certified Urology Nurse Practitioner, Division of Sexual and Reproductive Medicine, Department of Urology, University of Michi-

gan Health System, Ann Arbor, was less circumspect in her arguments. “There is no consensus about how to assess a defined group, or a way to treat people who have elevated PSA.” Questions remain regarding who should be screened, how screening

the rate was 1 in 11 men; today, it is 1 in 6. This is largely an increase in detection of localized cancer, not metastasis. “We see men with elevated PSA but don’t really know what to do with that information. Even before biopsy, this information alone increases anxiety,” Ms

“It has been said that widespread screening for PSA has created a pseudoepidemic….We don’t have really good evidence for benefit, but we have a lot of evidence for harm.” —Susanne A. Quallich, MSN, ANP-BC, NP-C, CUNP should be offered, how often, and how to advise patients about the results, she said. The value of PSA testing as a population-based screening is unclear even to the experts, considering the disagreements of the following guidelines: • The American Urological Association: yes to screening, but only for those well-counseled • The World Health Organization: no to screening, until large randomized trials show benefit • The European Association of Urology: no to widespread screening, because of insufficient evidence of benefit. “It has been said that widespread screening for PSA has created a pseudoepidemic,” said Ms Quallich. “We don’t have really good evidence for benefit, but we have a lot of evidence for harm.” This has even led one Harvard epidemiologist to say that PSA screening “is a disaster of contemporary medicine” (Adami HO. Acta Oncol. 2010; 49:275-277). Since its introduction, PSA testing has nearly doubled the chance of diagnosing prostate cancer in men: in 1980,

Quallich observed. Studies have shown that knowing that one may have cancer has a negative impact on that person’s health, including depression, anxiety, and voiding and bowel problems. In addition, prostate cancer treatment, which may not have been necessary, is associated with erectile dysfunction, bowel dysfunction, and incontinence. This is especially troubling considering that 50% of men with an elevated PSA level never have symptoms. “Ultimately, you can make the argument with PSA screening that we’re violating the idea that we do no harm,” Ms Quallich added. And we have not begun to discuss the associated costs. Finally, she said, as soon as a PSA threshold for concern is established, new data provide nothing but confusion. “One of the most interesting findings to come out in the last 8 to 12 months is that obesity causes a PSA to be lower than it would actually be,” Ms Quallich said. We have all heard about the obesity epidemic, she said, and with widespread PSA screening, what are we to do with these numbers? ■

ED Drugs Linked to STDs in Men Men who use drugs for erectile dysfunction (ED) have higher rates of sexually transmitted diseases (STDs), particularly HIV infection, according to a retrospective cohort study of claims from a database containing records from 1,410,806 men aged >40 years from 44 large companies (Jena AB, et al. Ann Intern Med. 2010;153:1-7). Of this cohort, 33,968 men had filled ≥1 prescription for an ED drug, and 1,376,838 had no ED drug prescriptions filled. Compared with nonusers, men using ED drugs had a 2.8-fold increased risk for contracting

an STD in the year before using the drugs, and about a 2.6-fold increased risk in the year after starting ED drugs. HIV infection risk was more than 3fold greater in those using ED drugs before and after starting the drugs than in nonusers. The researchers noted, however, that ED drug users had increased STD rates not only after starting the drugs but also in the year before initiating ED drugs, suggesting a potential link between certain behaviors of men with STDs rather than as a result of the use of ED drugs. ■

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Clinical News ACOG Relaxes Guidelines... Continued from page 5

ACOG President Richard N. Waldman, MD, said that these changes reflect the concern over the continuing high rate of cesarean deliveries.

New Combination OC with Lowest Estrogen Dose The US Food and Drug Administration granted approval in late October to a new combination oral contraceptive (OC), Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets). Expected to be commercially launched by its manufacturer early next year, this new combination OC offers the lowest dose of estrogen (10 Âľg) of any OC marketed in the United States. Like other combination OCs, Lo Loestrin Fe has a warning box concerning the risk for serious cardiovascular events in smokers. Among other adverse events reported in clinical trials were vomiting (7%), headache (7%), bleeding irregularities (5%), dysmenorrhea (4%), and weight changes (4%).

Novel Spermicide on Par with Nonoxynol-9 Nonoxynol-9â&#x20AC;&#x201D;the active ingredient contained in all spermicides on the marketâ&#x20AC;&#x201D;now has competition from C31G, a new spermicide. A recent study showed that C31G, a mixture of 2 surfactants, is noninferior to nonoxynol-9 (Burke AE, et al. Obstet Gynecol. 2010;116:1265-1273). The researchers randomized healthy, sexually active women, aged 18 to 40 years, to C31G (n = 932) or nonoxynol9 (n = 633). Among patients from both groups, all who had sex at least once during the 6-month study period, the 6month pregnancy probability was 12.0%; the 12-month pregnancy probability rates were 13.8% and 19.8%, respectively, for the C31G and nonoxynol-9 groups. Neither of 2 serious adverse events reported and thought to be potentially related to the study product occurred in the C31G group. Of note, although C31G has shown in vitro activity against chlamydia, HIV, and herpes simplex virus type 2, published evidence has not confirmed these protective effects.

IOM Ups Vitamin D & Calcium Recommendations for Most Americans The Institute of Medicine (IOM) has issued new recommendations for greater vitamin D and calcium intake for most Americans. Until now, the daily recommended dietary allowance (RDA) level for vita-

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min D for most age-groups was 400 IU, but a debate about the need for daily supplementation was common among experts. The new recommendations emphasize the benefit of vitamin D for bone health, but do not acknowledge the many other potential benefits that have been investigated in many studies and have received much publicity in the past few years. The new IOM recommendations set the new RDA levels at a daily vitamin

D intake of 600 IU for everyone between age 1 year and 70 years, including all women and teen-aged girls (aged 14-50 years) who are pregnant or lactating. For older persons of either sex who are >71 years, however, the IOM now recommends increasing the daily vitamin D to 800 IU supplementation. The IOM also recommends increasing the levels of calcium intake, based on age-group and sex. For children aged 1 to 3 years, the new recommen-

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december 2010 I Vol 2, No 6

OBGYN_1210_OBGYN 12/14/10 10:51 AM Page 28

Because she counts on you to know...

Only works with one daily dose It’s a fact. CRINONE is the only once-daily vaginal progesterone gel approved for ART through 12 weeks of pregnancy.1 The vaginal insert required three daily applications to achieve similar efficacy rates.2* When she asks about progesterone, give her the facts.

The only *Results based on a multicenter, randomized, open-label (assessor-blinded), non-inferiority study in 1,211 women aged 18 to 42 undergoing IVF to compare pregnancy rates using Endometrin® 100 mg BID, Endometrin® 100 mg TID, or CRINONE once daily.

CRINONE 8% (progesterone gel) is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency. Important Safety Information The most common side effects of CRINONE (progesterone gel) 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8% is contraindicated in patients with active, or a history of, thrombophlebitis or thromboembolic disorders, patients who have known sensitivity to CRINONE 8%, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. Should any of the earliest manifestations of thrombotic disorders occur, the drug should be discontinued immediately. No evidence is available to show that progesterone and progestins are effective in preventing miscarriage in women with a history of recurrent spontaneous pregnancy losses. The pretreatment physical exam should include special reference to breast and pelvic organs as well as a Papanicolaou smear. Nonfunctional causes of breakthrough bleeding should be considered, and for undiagnosed vaginal bleeding, diagnostic measures should be undertaken. Special care should be taken with patients who have conditions that may be influenced by fluid retention, those who have a history of psychic depression, and those with diabetes. Please see brief summary of full prescribing information on the adjacent page. Toll-free support line: 1-888-PRO-GEL8 (1-888-776-4358) References: 1. CRINONE® prescribing information. Morristown, NJ: Watson Pharmaceuticals, Inc. June 2010. 2. Doody KJ, Schnell VL, Foulk RA, et al. Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation. Fertil Steril. 2009;91:1012-1017. © 2010, Watson Laboratories, Inc.

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