Februay 2011, Vol 3, No 1

FEBRUARY 2011

WWW.THEOBGYNNURSE.COM

VOL 3, NO 1

CLINIC PROFILE

AWHONN HIGHLIGHTS

The Valley Hospital Fertility Center

Recognizing the Signs of Heart Disease in Women, Part 1

Superior Success Rate, Diverse Patient Population

Misconceptions Are Rampant

Interview with Margaret M. Robinson, RN Director, The Valley Hospital Fertility Center, Paramus, NJ

By Caroline Helwick

H

eart disease is not just a disease of older women; in fact, even pregnancy can place younger women at risk for heart-related conditions. This 3-part series will help guide nurses in the recognition and management of the number 1 killer of American women—heart disease.

This information was presented at the 2010 Association of Women’s Health, Obstetric and Neonatal Nurses meeting

by Carolyn Strimike, RN, MSN, CCRN, APN-C, of the Women’s Heart Center at St. Joseph’s Regional Medical Center, Paterson, NJ. Ms Strimike is an acute

care nurse practitioner and cofounder of Heartstrong, LLC (www.heart-strong. com). With her colleague Margie Latrella, she has coauthored 3 books, including Take Charge: A Woman’s Guide to a Healthier Heart (2008).

So, You Think You Know the Risk Factors?

“There has been an alarming increase in mortality from heart disease among women, possibly because they are more ‘complex’ than men,” Ms Strimike said.

Women have hormones that play critical roles in heart health. Declining Continued on page 4

Left to right: Ali Nasseri, MD, PhD; Sheeva Talebian, MD; Adrienne Marciniak, RN, BSN; Cathy McCabe, RN; Carol Zollinger, RN; Margaret Post, RN; Margaret M. Robinson, RN, Director; Dehan Chen, MD.

SPOTLIGHT

A

Novel Set of Beads Simplifies Pregnancy Planning

s the staff of the Valley Hospital Fertility Center in Paramus, NJ celebrates the milestones of a 10-year anniversary and helping to create 1000 babies, Margaret M. Robinson, RN, Director of Fertility and Embryology Services, took time to talk with the OB/GYN Nurse-NP/PA about the center and its services.

Could you tell us about the history of the clinic?

The Valley Hospital Fertility Center was originally put together in 2001 as a satellite affiliate of New York University (NYU) Fertility Center in New York City. Between 2001 and 2006 we did all the monitoring and saw patients in New Jersey, but our patients would then have Continued on page 11

NAMS HIGHLIGHTS

Errors Are Common with Osteoporosis Treatment Regimens

By Wayne Kuznar

A

bout half of postmenopausal women are unable to follow their osteoporosis treatment regimens, according to findings presented at the 2010 meeting of the North American Menopause Society.

Early identification of factors that can interfere with correctly following

the therapeutic regimen is imperative, and if women are found to be in a highrisk group for nonadherence, changes or adaptations should be introduced at the earliest possible time, advised Adriana O. Pedro, MD, PhD, Professor, Department of Obstetrics and Gynecology, Faculty of Medical Sciences, Continued on page 5

The Publicationof of The Official Offical Publication

We thank Watson Pharmaceuticals, Inc., for their gold level support. ©2011 Novellus Healthcare Communications, LLC

By Rosemary Frei, MSc

P

reventing or planning pregnancy has become easier, thanks to a cleverly designed set of beads that has also recently been released as an “app” on the iPhone for just $2.99.

CycleBeads (Photo) is a string of 32 beads that a woman can use to count the number of days since her period started and to let her know when she is likely or very unlikely to conceive.

A “virtual” version called iCycleBeads was launched in December. With the touch of a button, it shows women where they are in their menstrual cycle

and whether pregnancy is likely. A woman can also set the program to send alerts when she is inside or outside of her fertile window.

When used correctly, the beads are 95% effective. “Given the large number Continued on page 5

IN TH IS ISSUE COMPLIMENTARY CE

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PHARMACY CORNER

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Legal issues in surrogacy Fertility preservation options expanding WOMEN’S HEALTH . . . . . . . . . . . . . . .

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Cancer therapies and sexual dysfunction

Prenatal genetic testing Commentary: The reasons for prenatal testing INFERTILITY UPDATES

THE CANCER PATIENT

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Using OTC cough and cold agents in pregnancy MEN’S HEALTH

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Understanding BPH

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Home births and newborn deaths Ultrasound in pregnancy

NUTRITION

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Magnesium for prevention of sudden cardiac death in women

Committed to Fertility Pharmacy Excellence 8ZZi\[`k\[ Zfek`el`e^ \[lZXk`fe gif^iXdj G\\i$kf$g\\i Zc`e`ZXc glYc`ZXk`fej Fe\$fe$fe\ elij\ Xe[ gXk`\ek ZfejlckXk`fej EXk`feXc Zfm\iX^\ n`k_ Z\ekiXc Xe[ i\kX`c ]lcÓ ccd\ek For medication delivery call:

Frisco, Texas: 800-424-9002 Fax: 800-874-9179 fertility.walgreens.com/clinicians

©2011 Walgreen Co. All rights reserved. SP13361-0111

From the Editor WWW.THEOBGYNNURSE.COM 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

Continuing Our Professional Growth

F

inally, one of the worst winters is behind us. Now that the coats are stored away and the shovels have been put to rest, it is time for spring fever. I know that all of you are ready for sunshine, warm weather, and all the blooms and growth ahead. Spring is not only a season for nature to bloom, but also a time of year when nurses start to sow the seeds for professional growth throughout the year.

There are so many opportunities to consider.

For those of you on a tight budget, you may need to limit your continuing education (CE) to free opportunities offered by journals, such as the OB/GYN Nurse-NP/PA, and available online as well as in print. During this time of economic challenges, I am sure that many nurses will be considering the avenue of online CE options. If your finances allow, the upcoming Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) convention in Denver, CO, held June

Editorial Board

Senior Production Manager Lynn Hamilton Quality Control Director Barbara Marino 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 and Infertility Nurses. The OB/GYN Nurse-NP/PA provides practical, authoritative, cutting-edge information on the physiologic, medical, and psychological aspects of women’s health, focusing on the role of the OB/GYN practitioner, including nurses, NPs, and PAs, in patient care. Our journal offers a forum for nurses, nurse practitioners, physician assistants, administrators, researchers, and all others involved in OB/GYN and women’s health to discuss the entire scope of current and emerging diagnostic and therapeutic options, as well as counseling and patient follow-up for women throughout their reproductive years and beyond.

Written by nurses for nurses, the OB/GYN NurseNP/PA promotes peer-to-peer collaboration among all nursing professionals toward the advancement of integrated services for optimal delivery of patient care and offers continuing education for all nurses, NPs, and PAs involved in these interrelated fields of women’s health.

The OB/GYN Nurse, ISSN 2153-6562 (print); ISSN 2153-6546 (online), is published 6 times a year by Novellus Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831.

Copyright ©2011 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, OB/GYN Nurse, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831; Fax: 732-656-7938.

24-29, will likely be a great opportunity. Advance registration before April 15 offers a $100 savings. As expected, the topics are varied and meet the needs of all OB/GYN nurses.

If you are unable to attend the AWHONN convention, remember that there are many regional and local opportunities to explore. In every state, there is a Women and Children’s Health chapter of the State Nurses Association, which offers 1 or 2 conferences annually. Some states have a Maternal–Child Health Consortium, which reaches out to the nurses in their area. Another area to explore is the March of Dimes.

As you can see, the possibilities are endless. So, as we eagerly move into spring, take some time to think about your professional growth, and how it relates to giving your patients the best care possible.

Debra Moynihan, WHNP-BC, MSN

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

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

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

Jennifer Iannaccone, RNC Nursing Manager, IVF Coordinator IVF New Jersey

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

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

Sue Jasulaitis, RN, MS Clinical Research Manager Fertility Centers of Illinois, Chicago

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

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

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

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

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

Cheryl Kilbourne, RN Clinical Director Women and Children Services Waccmaw Hospital, SC

Christopher S. Sipe, MD OB/GYN & Reproductive Endocrinology Fertility Centers of Illinois, Chicago

Richard P. Dickey, MD, PhD Director, Reproductive Medicine Fertility Institute of New Orleans, LA

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

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

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

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

Kriston Ward, RN, MS, NP-C Strong Fertility Center University of Rochester Medical Center Rochester, NY

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

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

Joan Zaccardi, MS, DrNP Administrative Practice Manager Urogynecology Arts of New Jersey

EDITOR-IN-CHIEF

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

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

February 2011 I VOLUME 3, NUMBER 1

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AWHONN Highlights

Recognizing the Signs of Heart Disease... estrogen makes menopause the greatest risk factor for heart disease.

Other risk factors—including heredity, overweight/obesity, physical inactivity, smoking, hypertension, abnormal lipids, and diabetes/metabolic syndrome—are well established, but less recognized risks include: • Emotional stress • Gum disease • Inflammation • Sleep apnea • Depression • Resting heart rate >76 beats per minute.

In addition, the following risk factors are specific to women: • A female first-degree relative with heart disease conveys a stronger risk than a male relative • Smoking is linked to heart attacks/ strokes at a younger age in women than in men • Pregnancy-induced high blood pressure (BP) that later becomes normal increases the risk • High systolic BP • Abnormal lipids: low high-density lipoprotein cholesterol and triglyceride levels, as well as diabetes, are more robust risk factors in women • Hypo/hyperthyroidism is particularly relevant in women.

Risk factors “cluster” by race to some degree. The presence of ≥2 risk factors has been found in 60% of black women and only 30% of white women; ≥3 risk factors are found in 30% and 10% of these populations, respectively. Nearly 30% of white women, but <10% of black women, have no risk factors for heart disease.

“There has been an alarming increase in mortality from heart disease among women, possibly because they are more ‘complex’ than men.”

—Carolyn Strimike, RN, MSN, CCRN, APN-C

Much of this difference stems from a higher presence of elevated BP in blacks.

“African American women develop hypertension earlier in life, often in their 20s,” Ms Strimike said. “We need to be very aggressive in treating this.”

Heart Attack: Men versus Women “The TV movie symptoms of a heart attack—severe, crushing chest pain, nausea, shortness of breath—are de-

4

rived from clinical observations in men,” she noted. Women may demonstrate these symptoms, but they may also have: • Odd chest sensations • Shoulder-blade pain • Hot flushes/cold sweats • Dizziness • Unusual fatigue/weakness.

In-Hospital Mortality from Heart Table Attack: Men vs Women Age, yr

Women, %

Men, %

50-54

6

3

55-59

10

6

60-64

11

8

Once myocardial infarction (MI) occurs, outcomes are generally worse for women than for men (Table), through around age 70, when the rates become comparable. When women undergo cardiac bypass surgery, they have increased length of hospital stay, increased postoperative complications, and higher operative mortality compared with men.

It is a tragedy—and often a fatal one —when the signs and symptoms of an MI are not recognized, but these are not the only signs ignored by clinicians, Ms Strimike noted. Women are often diagnosed with anxiety rather than heart disease, when in fact they are having signs of MI, she said. Women who report chest pain, shortness of breath, and palpitations, along with high levels of life stress, tend to be diagnosed with anxiety rather than heart disease. In many studies, a diagnosis of heart disease was made in 15% of women with such signs compared with 56% of men.

The sex differences disappeared when no life stress was reported.

Arteries Are Different in Women and Men Finally, heart disease may be missed in women because abnormalities of the coronary arteries—the hallmark sign— may be lacking, she said. In the major coronary intervention studies, “normal” coronary arteries were documented in 20% to 30% of women with heart disease compared with just 7% to 14% of the men.

“In women who reported symptoms consistent with heart disease, 50% did not have their disease detected on cardiac catheterization, or had only minimal narrowing of blood vessels,” she said, “but 17% of them went on to have severe coronary artery disease at 5 years.

In women, we have to pay attention to mild narrowing of the arteries.”

In contrast, women are more likely to have “small-vessel disease,” which

February 2011 I VOLUME 3, NUMBER 1

includes spasm, edema, and small blood clots. Rather than a focal area of obstruction and obvious narrowing, in women a layer of plaque may line the entire vessel.

“Women have a more diffuse type of disease, and this may be related to hormones,” she said. “Blockage in the female coronary artery often will not show up on a stress test or heart catheterization. This is why we need additional

Declining estrogen makes menopause the greatest risk factor for heart disease. Women are often diagnosed with anxiety rather than heart disease, when in fact they are having signs of MI. tools, such as intravascular ultrasound, which can reveal arterial disease, to diagnose heart disease in women.”

Watch for the Symptoms Nurses can help to identify women at risk by the presence of symptoms and family history, as well as when a physical examination reveals elevated BP,

Continued from page 1

Additional Testing • C-reactive protein: a blood test that measures the level of inflammation in the body, which is a marker of increased risk • Echocardiogram: ultrasound that measures the size of the heart chambers, the heart’s pumping capacity, and the functioning of the heart valves • Electrocardiogram: measures the electrical activity of the heart • Intima-media thickness: ultrasound of the neck arteries; thickening indicates increased risk • Coronary artery calcium scoring: computed tomography scan measuring calcium level in the arteries; the higher the score, the greater the risk for a heart attack • Nuclear stress test: determines if all areas of the heart are well perfused abnormal lipids, excess weight or body fat (waist/hip/neck measurement, waistto-hip ratio, body mass index, and body fat analysis are recommended), and diabetes or metabolic syndrome. If this screening indicates an intermediate risk of heart disease, a woman should be encouraged to undergo additional cardiac testing. ■

SSRI Reduces Severity of Menopausal Hot Flashes

M

enopausal women may find some relief from hot flashes with escitalopram, a selective serotonin reuptake inhibitor (SSRI) that reduced the severity of hot flashes in healthy women (Freeman EW, et al.

Efficacy of escitalopram for hot flashes in healthy menopausal women. JAMA. 2011;305:267-274).

With the growing concern for potential risks associated with estrogen/ progesterone therapy for menopausal symptoms, researchers are looking at nonhormonal alternatives. Studies involving serotonin and norepinephrine reuptake inhibitors and SSRIs have yielded varied results; 2 pilot studies on escitalopram showed reductions in hot flashes with minimal toxicity, but both had small populations and unblinded treatment.

This current double-blind study compared the efficacy of escitalopram and placebo for hot flashes in 205 women (95 black, 102 white, and 8 other) who were randomized to 10 to 20 mg daily of escitalopram or matching placebo for 8

weeks. Women receiving escitalopram were started on 10 mg/day, which was increased to 20 mg/day if they did not report a reduction in the frequency of hot flashes after 4 weeks. Primary (frequency and severity of hot flashes) and secondary (hot flash bother) outcomes were evaluated by daily diaries completed by the women.

Baseline mean frequency of hot flashes was 9.78/day, which at week 8 was significantly reduced with escitalopram (47%; 5.26/day) compared with placebo (6.43 per day). Hot flashes frequency decreased by ≥50% in 55% of those receiving escitalopram versus 36% of the placebo group.

The mean decrease in hot flashes severity score was 24% in the escitalopram group and 14% in the placebo group.

A 3-week postintervention followup after cessation of escitalopram and placebo showed increased hot flashes in the escitalopram group but not in the placebo group, an observation that the researchers took as further proof of the drug’s effectiveness. ■

Spotlight

Novel Set of Beads Simplifies Pregnancy Planning... of women who fail to get pregnant because they are mistaken about when they are likely to conceive, it is important that members of the healthcare community let women know about the importance of tracking their fertility and the availability of an easy-to-use, lowcost, scientifically based tool to help them do so,” said Victoria Jennings, PhD, one of the creators of CycleBeads and Director of the Institute for Reproductive Health at Georgetown University, Washington, DC. Jane Mashburn, CNM, MN, FACNM, Program Director and Specialty Coordinator, Nurse-Midwifery/Family NurseMidwifery programs, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, who was not involved in the development or marketing of CycleBeads/iCycleBeads, told the OB/GYN Nurse-NP/PA that she is impressed by the beads.

“I think they will be beneficial for those desiring pregnancy, as well as those who use the beads to identify their times of infertility.”

—Jane Mashburn, CNM, MN, FACNM

“I think they will be beneficial for those desiring pregnancy, as well as those who use the beads to identify their

times of infertility,” Ms Mashburn said.

“And having the phone app readily available will be very useful for people, especially if they travel.”

CycleBeads were introduced worldwide in 2002, after extensive testing by Georgetown University researchers.

They are now being used by more than 2 million women in more than 50 countries, including the United States.

A number of family planning organizations supported by Title X of the Public Health Service Act have purchased CycleBeads at a low bulk price for their clients and “often give them away for free or for a very low fee,” Dr Jennings said.

The beads have a black ring that is used to track the days of a woman’s

cycle. To begin using CycleBeads, the woman waits for the first day of her period and then places the black ring over the red bead. Then once a day she moves the black marker clockwise to the next bead. This can be done with the beads themselves, or “virtually” using iCycleBeads. She then moves the ring to the red bead when her next period starts and repeats the process.

When the black ring is on any of the colored beads, the woman has a very low chance of becoming pregnant. Pregnancy is very likely when the ring is on any of the white beads—days 8 through 19 of the menstrual cycle (when the egg is available for fertilization).

The dark brown bead is used to let women know if their menses are <26 days. CycleBeads/iCycleBeads are de-

signed for the approximately 80% of women who have cycles ranging between 26 and 32 days.

The beads are also available in retail settings (www.cyclebeads.com) and— thanks to Cycle Technologies, which manufactures and distributes Cycle Beads under license from Georgetown University—can be purchased in an electronic format, at http://itunes. apple.com/us/app/icyclebeads/id401996 963?mt=8.

“Nurses can direct women to information on the Internet about the beads,” Dr Jennings said. “They can also give them some of the basic information about how they work—for instance, if she has regular cycles in the 26- to 32-day range, they will identify a window of time during which she is likely to be fertile.” ■

Errors Are Common with Osteoporosis Treatment...

State University of Campinas, Brazil.

She and colleagues performed a cross-sectional study of 227 postmenopausal Brazilian women with a diagnosis of osteopenia or osteoporosis who were being treated with antiresorptive drugs.

Approximately half (46%) of the women were being treated with daily alendronate, 26.5% with weekly risedronate (35 mg), 20.9% with weekly alendronate (70 mg), 4.3% with raloxifene, and 1.7% with 5 mg of risedronate.

Overall, less than 80% of women were able to follow treatment instructions.

Fewer women who took raloxifene or risedronate were able to follow treatment than those who took alendronate.

Almost all the patients using a bisphosphonate took their medications correctly on a daily or weekly basis, in the morning on an empty stomach,

whereas only 70% of those taking raloxifene did so correctly. However, less than 50% of the women taking daily or weekly bisphosphonate and 30% of

“If you have older women who can’t read and don’t take many medications, they should be seen more often to check if they are really taking their medication.”

—Adriana O. Pedro, MD, PhD

those taking raloxifene knew the correct dose, she said.

Women aged >70 years were 5 times more likely to make errors in their reg-

imen than those aged ≤70 years, and illiterate women were 10 times more likely to make errors than those who were literate. Those who were taking their regimen for only a short time were also significantly more likely to make errors.

In contrast, women who took additional medications were better able to follow their treatment regimen than those who took only 1 medication.

“Obtaining information about how, when, and if the patient is taking medication correctly can contribute to the implementation of effective individualized measures, which aim to better therapeutic adherence…thus diminishing morbidity and mortality resulting from ineffective treatment,” Dr Pedro said.

“If you have older women who can’t read and don’t take many medications, they should be seen more often to check if they are really taking their medica-

Continued from page 1

Continued from page 1

TAKEAWAY QUICK POINTS ➤ Make sure your older patients can follow the instruction for osteoporosis medications. ➤ Ask older women who have been prescribed these medications if they are taking their medications regularly. ➤ For your female patients aged >70 years, explain why taking these medications is important for their health, and make sure they know how often they should be taking them.

tion,” she said. “Younger women who are literate and are taking many medications can have a longer interval between medical visits.” ■

February 2011 I VOLUME 3, NUMBER 1

5

Infertility Updates

Surrogacy and the Complexities of Establishing Legal Parentage Melissa B. Brisman, Esq, and Lauren Murray, Esq Ms Brisman is the owner of Melissa B. Brisman, Esq, LLC, Reproductive Possibilities, LLC, and Surrogate Fund Management, LLC. Ms Murray is an associate at Melissa B. Brisman, Esq, LLC.

G

estational surrogacy is a wonderful option for individuals and couples who are unable to conceive and bear a child without the assistance of a third party. The rewards of such arrangements are tremendous, but gestational surrogacy is also inherently complicated—medically, emotionally, and legally. The ability of the intended parents to establish their legal parentage over the child is what some would consider the most important legal concern accompanying a gestational surrogacy arrangement.

Judicial Birth Order For most intended parents, the preferred method for establishing their legal parentage is a judicial order of parentage obtained from the court before the birth of the anticipated child. These orders have various names but are most often referred to as “birth orders.” A typical birth order names the intended parents as legal parents and terminates the gestational carrier’s rights.

With a birth order in place, the intended parents are the legal parents of the child from the moment of birth.

Some courts will issue birth orders before birth, whereas others will only issue orders after birth.

The availability of pre- and postbirth orders vary from state to state, and sometimes from county to county within a state. The availability of birth orders can also depend on the particular intended parent’s circumstances. For example, some courts will only grant a birth order when there is a biological connection between the intended parent and the anticipated child. Although this article does not provide a comprehensive review of all 50 states, the selection of states highlighted here are intended to demonstrate the variations that exist across the United States.

Surrogacy Law Varies by State Most US states do not have specific statutory law governing gestational surrogacy or establishing a procedure for obtaining birth orders. Instead, in most states, the procedure for obtaining a birth order has been created over time by reproductive attorneys working directly with the courts to obtain the birth order that their clients require.

States without specific statutory law.

In the Commonwealth of Pennsylvania, for example, no specific statutory law

6

Melissa B. Brisman

Lauren Murray

exists governing surrogacy or establishing intended parents’ legal parentage.

Nevertheless, in many counties across the state, a reproductive attorney can file a petition during the pregnancy in the county where a gestational carrier lives or intends to deliver, and obtain a birth order before birth.

Whether an attorney can obtain a birth order for intended parents in sit-

contrast to these states, a few states do have specific statutory law in place governing gestational surrogacy arrangements and the process for establishing intended parents’ legal parentage in connection with these arrangements.

These states include Florida, Texas, Utah, Virginia, and Illinois.

The advantage to these states is that intended parents know that if they satis-

Pennsylvania is one of the best examples of a state in which birth orders are available based on practice and precedent rather than on specific statutory law. Other states similar to Pennsylvania include Massachusetts, Maryland, Georgia, and Minnesota.

uations where one or both of them is not biologically connected to the child will depend on the county of filing.

Likewise, some counties in Pennsylvania will only grant the birth order on the birth of the child. Some county courts in Pennsylvania have yet to issue a birth order, either because petitions for birth orders have been denied in that county or because an attorney has yet to seek a birth order in that particular location.

Pennsylvania is one of the best examples of a state in which birth orders are available based on practice and precedent rather than on specific statutory law. Other states similar to Pennsylvania include Massachusetts, Maryland, Georgia, and Minnesota.

States with specific statutory law. In

February 2011 l VOLUME 3, NUMBER 1

fy the requirements of the surrogacy law in the state and follow the procedures specifically set out for them to establish their legal parentage, the availability of the birth order is largely assured.

The disadvantage to these states, however, is that the statutory process to establish legal parentage may set out specific requirements that some intended parents cannot meet. For example, in Texas the intended parents must be married, and either the intended parents or the gestational carrier must be a Texas resident. If they cannot meet these requirements, they lose the benefit of the statute. This does not mean that they absolutely cannot establish their legal parentage in Texas, but the process can be complicated and comes with significantly

less of a “guarantee.”

In Florida, the statute does not appear to contain a residency requirement, but at least 1 intended parent must be biologically related to the child to be delivered by the gestational carrier, and the intended parents must be married.

Utah law also requires the intended parents to be married. Utah is unique in that intended parents must begin the legal process to declare their legal parentage very early in their gestational carrier arrangement. In fact, they are required to validate a gestational carrier agreement between themselves and their gestational carrier before their first attempt at embryo transfer.

In Illinois, no court filing or court appearance is required to establish legal parentage. Instead, Illinois statutory law created an administrative mechanism to establish legal parentage. Although intended parents must still satisfy certain statutory requirements, including demonstrating that at least 1 intended parent is biologically related to the child to be born, legal parentage is established through submission of standard paperwork.

Virginia statutory law is a bit of a hybrid, providing either a judicial or administrative mechanism to establish intended parents’ legal parentage. The administrative mechanism, which is preferred by most intended parents, takes place after birth.

When Birth Order Is Not Available Unfortunately, there are also states where birth orders are simply not available. This has been the case, for example, in Alabama. Where birth orders are not available, adoption remains the primary option to establish the intended parents’ legal relationship to a child born via gestational surrogacy.

Although the birth order process is normally the last legal step in the surrogacy process, intended parents must be conscious of this issue early in the surrogacy process—preferably, when they are searching for or considering matching with a gestational carrier. An experienced reproductive attorney should be able to investigate and predict the options for establishing legal parentage so that intended parents can make a fully informed decision about moving forward with their potential gestational carrier. ■

Infertility Updates ASRM HIGHLIGHTS

Fertility Preservation Options Vary by Cancer Type

By Wayne Kuznar

W

ith continued improvement in assisted reproductive technology, the landscape for fertility preservation in the female cancer patient has changed for the better, said Nicole Noyes, MD, Professor and Codirector of the Oocyte Cryopreservation Program at New York University Fertility Center, at the 2010 meeting of the American Society for Reproductive Medicine (ASRM).

More women are pursuing fertility preservation than ever before, and the 2006 guidelines from the American Society of Clinical Oncology (ASCO) recommend that patients who are interested in fertility preservation options be referred to fertility preservation expertise.

Considerations in the choice of fertility preservation include the patient’s age, type of cancer and planned treatment, available time before starting cancer treatment, overall health of the patient and, if a single woman, her willingness to use donor gametes. More than 1 option may be possible for a given patient, said Dr Noyes.

Cryopreservation May Offer an Advantage Embryo banking is still considered the standard of care, and has a live birth rate of approximately 33%. By comparison, oocyte cryopreservation, which is still considered experimental by ASRM, has a live birth rate of 39.3%, and appears to have no increase in birth anomalies compared with natural conception.

Approximately 50% of in vitro fertilization centers in the United States offer oocyte cryopreservation, she said.

Oocyte cryopreservation has the advantage of reproductive autonomy, because it does not require the use of donor sperm.

A recent randomized controlled comparison that included 600 donor egg recipients showed no difference in implantation rates and clinical pregnancy rates between vitrified and fresh oocytes (Cobo A, et al. Hum Reprod.

2010;25:2239-2246).

And in a series of 90 patients with cancer who underwent ovarian hyperstimulation and oocyte cryopreservation, Dr Noyes and colleagues found that adequate ovarian stimulation could be achieved (Noyes N, et al. J Assist Reprod Genet. 2010;27:495-499). There were no differences between cryopreservation cycles performed in patients with cancer and in women without cancer.

“We can complete stimulation very quickly—within 2 weeks,” she said. “We tend to dose up with gonadotropins.”

Newer Options Require More Data Some of the newer technologies for fertility preservation have limited data on effectiveness, said Clarissa Gracia, MD, Director of Fertility Preservation at Penn Fertility, University of Pennsylvania.

“Ovarian tissue pieces are more resilient in younger women; this is not a treatment for women who are 40 or older.”

—Nicole Noyes, MD

In vitro maturation of immature oocytes is considered experimental. In a study of women with normal ovaries, in vitro maturation with follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hCG) priming was associated with higher clinical pregnancy rates than without priming or with FSH or hCG priming alone (Fadini R, et al. Reprod Biomed Online.

2009;19:343-351).

There have been few successes with ovarian tissue banking, which is also considered experimental, said Dr Gracia.

Ovarian tissue banking requires surgical removal of ovarian tissue. Ovarian stimulation is not necessary, no partner is required, and delays in treatment are minimal. A review of published data using orthotopic transplants of cryopreserved ovarian tissue reveals 10 live births in 8 patients with cancer.

Other challenges to fertility preservation in the patient with cancer are fitting fertility preservation into the cancer treatment schedule and uncertainties about ovarian stimulation, such as the safety of stimulating close to administration of gonadotoxic chemotherapy or with a tumor present.

Dr Noyes provided an overview of fertility preservation options for patients with specific cancer diagnoses.

Patients with Breast Cancer In patients with breast cancer, if surgery is performed first (before adjuvant chemotherapy), there is usually time for fertility preservation between the surgery and the start of chemotherapy, Dr Noyes said. If chemotherapy is administered first, ovarian stimulation is per-

formed with a full tumor load.

Continuation and return of menstrual bleeding depends on the chemotherapy regimen, the age of the patient, and the use of tamoxifen in women treated for breast cancer.

Monthly bleeding returned within 1 month after standard courses of chemotherapy more often with a regimen of cyclophosphamide, methotrexate, and fluorouracil than with doxorubicin and cyclophosphamide.

Dr Noyes urged caution in interpreting these results, saying that “menses does not mean motherhood.” Tamoxifen use was associated with a decrease in bleeding after completion of chemotherapy.

Patients with Hematologic Malignancies Patients with hematologic malignancies require rapid treatment (sometimes before fertility preservation), and they usually have a full tumor load at the time of fertility preservation treatment.

“They may have relapse after first fertility-sparing cancer treatment and require a more gonadotoxic protocol with chemotherapy or bone marrow transplantation,” Dr Noyes said.

with Hodgkin’s or non-Hodgkin’s lymphoma, all of whom were in their 20s at the time. “Ovarian tissue pieces are more resilient in younger women; this is not a treatment for women who are 40 or older,” Dr Noyes noted.

Reimplanting cryopreserved ovarian tissue from women with certain hematologic cancers runs the risk of reseeding the cancer and therefore may not be safe, said Dr Noyes. (In 2006, ASCO recommended ovarian tissue screening to detect malignant cells to minimize the risk of cancer cell transfer with the ovary.)

Gynecologic Malignancies Gynecologic cancers have their own unique considerations for fertility preservation, because they often require removal of organs associated with reproduction.

Removal of the uterus in the management of gynecologic cancers warrants a thorough discussion, because implantation at the uterine level is not affected by a woman’s age.

In the case of endometrial cancer, “if it can’t be treated with hormones, the uterus will have to come out, in which

In patients with breast cancer, if surgery is performed first, there is usually time for fertility preservation between the surgery and the start of chemotherapy,

Ovarian stimulation may be challenging in women with hematologic cancers because ovarian follicles (particularly antral and larger) may be destroyed during chemotherapy. Ovarian stimulation is not possible during chemotherapy and can be challenging shortly after chemotherapy. Also, it is not clear how long to wait after cancer therapy to see the response to ovarian stimulation. Furthermore, the safety of in vitro fertilization immediately after cancer therapy is unclear with respect to embryo development and implantation, as well as the risks of aneuploidy and malformation.

Ovarian tissue cryopreservation before chemotherapy may be an option for fertility preservation in women with hematologic cancers.

Among the 10 births resulting from autologous transplantation of follicles or strips of cryopreserved ovarian cortical tissue, 5 have been by women

case we can either make eggs or embryos that can go into a gestational carrier,” Dr Noyes pointed out. “The use of gestational carriers is much more common now than it was a few years ago.” She said that there are approximately 800 known cases of gestational carriers in the United States.

Patients with ovarian cancer often have decreased ovarian reserve.

Various modalities can assess ovarian reserve, the most common being assessment of FSH and estradiol. In addition, noninvasive sonographic evaluation can help in the assessment of ovarian function. ■

SEE ALSO The Cancer Patient section on page 17.

February 2011 l VOLUME 3, NUMBER 1

7

Women’s Health

OB/GYN Experts Denounce Study’s Conclusion That Home Births Triple Newborn Deaths

By Rosemary Frei, MSc

A

group of academics is asking the editors of the American Journal of Obstetrics and Gynecology (AJOG) to retract a recent meta-analysis study that suggested that less medical intervention during planned home birth is associated with a tripling of neonatal mortality rate.1 The study at the center of the controversy is this meta-analysis of several studies on maternal and newborn outcomes in planned home births and planned hospital births.1 Saraswathi Vedam, RM, MSN, CNM, SciD(hc), Director, Division of Midwifery, at the University of British Columbia, Vancouver, is one of the authors of a 9-page letter detailing the weaknesses of this meta-analysis.

“It is disturbing, because it has the potential to be quite misleading and give the public the impression that home births give their babies 3 times the risk of dying. As a mother, I know that no one is more concerned about their health and their babies’ health than mothers,” Dr Vedam told the OB/GYN Nurse-NP/PA. “In our letter, we provide a detailed statistical analysis of how it’s impossible to come up with the numbers that the authors do in their tables.”

An editorial in the Lancet titled “Home birth—proceed with caution,” which took the AJOG article at face value,2 added to the uproar in the OB/GYN community.

Dr Vedam and coauthors also sent their letter to the Lancet in response to this editorial. The Lancet issued a second editorial, noting that the letter writers— who include lead authors of 4 studies comprising more than 93% of patients included in the meta-analysis—believe the meta-analysis is “deeply flawed”3 and with “mistakes in definitions, numerical errors, selective and mistaken inclusion and exclusion of studies, conflation of association and causation, and other statistical problems.”3 The AJOG editors have sent the meta-analysis out for a second round of peer review.

Joseph Wax, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Maine Medical Center, Portland, led the meta-analysis.

Dr Wax and colleagues examined 12 studies with combined 342,056 home births and 207,551 hospital deliveries.1 Their calculations suggest that among 7 studies on home births versus hospital births, home birth mortality nearly dou-

8

bled when analyzing all neonatal deaths, and nearly tripled when analyzing only nonanomalous deaths in 6 studies.1 Among the groups concerned about the flaws in the meta-analysis is the American College of Obstetricians and

“It is disturbing, because it has the potential to be quite misleading and give the public the impression that home births give their babies 3 times the risk of dying.”

—Saraswathi Vedam, RM, MSN, CNM, SciD(hc)

Gynecologists–sanctioned American College of Nurse-Midwives,4 which noted that only 3 studies in the metaanalysis clearly distinguish between planned and unplanned home births; of these, only 1 meets the gold standard for quality home birth research, and is large enough (>480,000 births)

to warrant solid conclusions about neonatal mortality.5 Yet this study did not show that neonates born in planned home births were more likely to die or suffer severe illness in the first week of life than those born in planned hospital births.5 Although this study provided the majority of the study population for the meta-analysis, the investigators excluded it (for unclear reasons) from the evidence used to calculate neonatal mortality rate.1 News releases from the National Association of Certified Professional Midwives in the United States6 and the National Childbirth Trust in the United Kingdom7 further show that the meta-analysis excluded the only prospective study of planned home births involving certified professional midwives in the United States.8 That study showed that home births are associated with lower rates of medical intervention than low-risk hospital births, and with similar rates of intrapartum/ neonatal mortality.8 The same conclusions were reached

by Canadian investigators involving registered midwives and approximately 23,000 births.9,10

This controversy will likely continue in the literature and in the hallways of healthcare facilities for months to come. ■ References 1. Wax JR, et al. Maternal and newborn outcomes in planned home births vs planned hospital births: a metaanalysis. Am J Obstet Gynecol. 2010;203:243.e1-243.e8.

2. Home birth—proceed with caution. Lancet. 2010; 376:303.

3. Horton R. Offline: urgency and concern about home births. Lancet. 2010;376:1812.

4. American College of Nurse-Midwives. The American College of Nurse-Midwives ACNM expresses concerns with recent AJOG publication on home birth. July 7, 2010. www.midwife.org/documents/ACNMstatement onAJOGhomebirthstudy_071310_2__2_.pdf. Accessed January 21, 2011.

5. de Jonge A, et al. Perinatal mortality and morbidity in a nationwide cohort of 529,688 low-risk planned home and hospital births. BJOG. 2009;116:1177-1184.

6. National Association of Certified Professional Midwives. Press release. July 6, 2010. www.nacpm.org/doc uments/070610-NACPM-Press-Release-Wax-etal.pdf.

Accessed January 21, 2011.

7. National Childbirth Trust. US study on home birth response. Press release. August 7, 2010. www.nct.org. uk/press-office/press-releases/view/222#. Accessed January 21, 2011.

8. Johnson KC, Daviss BA. Outcomes of planned home births with certified professional midwives. BMJ. 2005; 330:1416.

9. Hutton EK, et al. Outcomes associated with planned home and planned hospital births in low-risk women attended by midwives in Ontario, Canada, 2003-2006.

Birth. 2009;36:180-189.

10. Janssen PA, et al. Outcomes of planned home birth with registered midwife versus planned hospital birth with midwife or physician. CMAJ. 2009;181:377-383.

Genetic Testing in Newborns Can Leave Families in Limbo

By Jessica A. Smith

A

lthough mandated genetic testing of newborns may provide peace of mind for some, it has wreaked havoc on other families who receive positive results, according to a recent study (Timmermans S, et al J Health Soc Behav.

2010;51:408-423). When newborns screen positive for risk of a metabolic, endocrine, or hemoglobin condition but do not yet show signs of the disease, their families are left hoping for the best but bracing for the worst.

When genetic screening for up to 29 conditions in newborns expanded to become mandatory in 2005, it brought with it unforeseen consequences, according to the researchers, who for 3 years followed 75 families whose newborns had tested positive for disease risk factors. A total of 40 neonates fell under the “patients-in-

February 2011 I VOLUME 3, NUMBER 1

waiting” umbrella, namely, remaining asymptomatic.

Results also showed that the parents’ fear and uncertainty about their child’s health status can result in

Results also showed that the parents’ fear and uncertainty about their child’s health status can result in behaviors that may ultimately cause more harm than good. behaviors that may ultimately cause more harm than good, including enforcing restrictive diets, limiting

contact with other people, not allowing the child to sleep through the night, and other measures.

The parents also often alter their own lives because of this ambiguous health status of the offspring, such as avoiding job change because of health insurance or opting not to make a move because of proximity to existing healthcare providers.

Such behaviors are only exacerbated by inconclusive results from retesting. In these instances, the researchers state, parents often find it difficult to let go of their vigilance surrounding the child’s health status.

Internet searches can add to this confusion. The researchers emphasized the need for minimizing the uncertainty for families, suggesting that follow-up tests be conducted as soon as possible after initial screenings. ■

Clinical News MRI Best for Detecting Early Breast Cancer in High-Risk Women

Buprenorphine Preferred to Methadone for OpioidDependent Pregnant Women

Magnetic resonance imaging (MRI) has been found superior to mammography in detecting early breast cancer in women at high risk for the disease, according to the results of a Dutch study (Rijnsburger AJ, et al. J Clin Oncol.

2010;28:5265-5273).

A total of 2157 women at risk for breast cancer were included in the study, with 1069 at high risk and 498 at moderate risk. For this comparison, only the 75 tumors that were found during screening were included and followed up for 5 years. MRI showed greater sensitivity (70.7%) than mammography (41.3%) in all these breast cancer cases. For invasive breast cancer, the sensitivity rates were 77.4% for MRI and 35.5% for mammography.

The difference in sensitivity between the 2 screening modalities was significant (P = .016). In contrast, mammography sensitivity was found to be much greater (69.2%) than that of MRI (38.5%) for ductal carcinoma in situ cancers.

For managing opioid dependence in pregnant women, methadoneâ&#x20AC;&#x201D;and the neonatal abstinence syndrome (NAS) that comes with prenatal exposureâ&#x20AC;&#x201D; may have met its match with buprenorphine. A recent study comparing the 2 drugs showed better results in neonates born to mothers receiving buprenor-

phine than methadone (Jones HE, et al.

N Engl J Med. 2010;363:2320-2331).

The double-blind, double-dummy, flexible-dosing, randomized, controlled study examined 131 neonates, with 58 exposed to buprenorphine and 73 exposed to methadone. Neonates whose mothers received buprenorphine required significantly less morphine for opioid withdrawal than those in the methadone group, with a mean dose of

1.1 mg compared with 10.4 mg, respectively. The buprenorphine-exposed neonates also had significantly shorter hospital stays (10.0 days vs 17.5 days) and durations of treatment for NAS (4.1 days vs 9.9 days) compared with their methadone-exposed counterparts. â&#x20AC;&#x153;These results are consistent with the use of buprenorphine as an acceptable treatment for opioid dependence in pregnant women,â&#x20AC;? the researchers wrote.

Continued on page 10

Not all pre-natalâ&#x20AC;&#x2122;s are created equal!

Smoking in Pregnancy Linked to Childâ&#x20AC;&#x2122;s Potential Criminal Record Heavy smoking by women while they are pregnant significantly increases the offspringâ&#x20AC;&#x2122;s probability of having a criminal record in adulthood, a new study has shown (Paradis AD, et al. J Epidemiol Community Health. 2010 Nov 15.

Epub ahead of print).

The investigators examined data from 3766 members of the Providence, RI, cohort of the Collaborative Perinatal Project from whom data was available when they became adults.

Children of mothers who smoked at least 20 cigarettes daily during pregnancy were more likely to have an adult arrest record than were children of women who did not smoke at that period (odds ratio, 1.31). The Harvard team controlled for many confounding influences, including level of maternal education, family history of mental health problems, and controlling or hostile maternal parenting. This finding applied similarly to male and female offenders.

This study helps to clarify whether there is a link between maternal smoking and criminal behavior among their adult children. Earlier research had identified a connection, but it was not clear whether the relationship was causal or caused by confounding variables. The researchers reported that they â&#x20AC;&#x153;found a robust associationâ&#x20AC;? between heavy smoking and offspring criminal records after controlling for 17 variables.

Make the connection at www.neevoprenatal.com

Prenatal vitamins containing synthetic folic acid have limitations.

See if the benefits of NeevoDHAÂŽ are for you.

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February 2011 l VOLUME 3, NUMBER 1

9

Clinical News Chlamydia Infection and Ectopic Pregnancy Researchers in the United Kingdom have uncovered at least some of the molecular associations that explain the link between Chlamydia trachomatis and ectopic pregnancy.

The full mechanism by which C trachomatis infection leads to ectopic pregnancy—which, in the Western world, is the most common cause of maternal mortality in the first tri-

mester—remains murky. The investigators set up a series of experiments involving fallopian tube tissue removed during the course of hysterectomy (Shaw JL, et al. Am J Pathol.

2011;178:253-260).

The studies confirmed that fallopian tube tissue taken from women who had been infected with C trachomatis was more likely to produce the protein PROKR2. One of the effects of this protein is to increase the probability

that an embryo will implant in the tissue in which it occurs.

This effect is mediated by a member of a family of cell-surface pattern-recognition receptors and by a protein complex that controls the transcription of DNA.

Injectable/Oral Contraceptives Don’t Affect Glucose Levels Long-Term Fasting glucose and insulin levels

Nature’s Active Folate for Prenatal Care NÉEVODHA® capsule Rx Description is a medical food for use only under medical supervision for the dietary management of impaired metabolic processes in women under a doctor’s care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions Folates, when administered as a single agent in doses above 0.1mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

The product contains: Each Blue gelatin capsule contains: Dietary Ingredients: L-Methylfolate Calcium(as Metafolin®)* .............................................................................1.13mg** Calcium (tricalcium phosphate) ............................................................................................. 75mg Elemental Iron (ferrous fumarate) .......................................................................................... 27mg Vitamin C (ascorbic acid)....................................................................................................... 40mg Vitamin E (D-alpha-tocopherol) .................................................................................................30IU Vitamin B6 (pyridoxine as pyridoxine HCI) ............................................................................ 25mg Vitamin B9 (folic acid) ...................................................................................................... 400mcg Vitamin B12 (methylcobalamin) ................................................................................................. 1mg Docosahexaenoic Acid (DHA) ............................................................................................. 250mg*** *CAS# 151533-22-1 is the registry of the absolute stereochemistry of L-methylfolate calcium. **1.13mg L-Methylfolate (calculated as L-methyltetrahydrofolic acid) is the molar equivalent of 1.0mg folic acid. Metafolin® (L-Methylfolate) is a registered trademark of Merck KGaA, Darmstadt, Germany. ***Docosahexaenoic acid (DHA) from an algal source. *Metafolin (L-methylfoalte calcium) is a substantially diastereoisomerically pure source of L-methylfolate containing not more than 1% D-methylfolate which results in not more than 0.011 milligrams of D-methylfolate in NeevoDHA. Capsule Ingredients: DHA (docosahexaenoic acid from an algal source), gelatin, tricalcium phosphate, glycerine, beeswax, ferrous fumarate, ascorbic acid, lecithin, pyridoxine HCI, D alpha tocopherol, soybean oil, L-methylfoalte, titanium dioxide, methylcobalamin, folic acid, ethyl vanillin, FD&C blue #1, FD&C red #40, food grade white ink (ammonium hydroxide, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze in SD-45, simethicone, titanium dioxide). CONTAINS SOY Indication and Usage NeevoDHA® capsules are for the specific dietary management of impaired metabolic processes in those women with distinct nutritional requirements for any of the following conditions: hyperhomocysteinemia during pregnancy 4,5,6,7; high risk recurrent pregnancy loss 5,7; impaired folic acid absorption 2,3; impaired metabolism due to 677C-T mutations in the methylenetetrahydrofolate reductase gene 8,10,11; and dysfunctional folic acid metabolism 11,12. NeevoDHA® should only be used under medical supervision.

Rationale for Distinct Nutritional Requirements Medical foods are intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.

NeevoDHA® contains folate in the form of L-methylfolate which is the biologically active folate isomer.

L-methylfolate is the body’s preferred form of folate because it is directly usable by the human organism for certain metabolic processes. There are well documented studies 2, 3, 6,8,12 which have established folic acid’s ineffectiveness regarding inherited disorders of folate transport and metabolism. These disorders limit and impair the capacity to ingest, digest, absorb or metabolize folic acid. Folic acid, the synthetic form of folate, must be metabolized in a four step process by the body to become the biologically active L-methylfolate. Unmetabolized levels of folic acid were found in 78% of plasma samples from women given >400 mcg of folic acid per day 1. Unmetabolized folic acid has a high affinity to bind to the cellular folate transport mechanism. This has been shown to reduce the transfer of the active metabolite L-methylfolate across the blood brain barrier 2,3.

D-methylfolate or 6(R)-5-methyltetrahydrofolate [6(R)-5-MTHF] is the other diastereoisomer of folate.

Studies administering doses of 2.5 mg per day or higher resulted in plasma protein binding of D-methylfolate higher than L-methylfolate causing a significantly higher renal clearance of L-methylfolate when compared to D-methylfolate.4 Further, D-methylfolate is found to be stored in tissues in the body, mainly in the liver. D-methylfolate is not metabolized by the body and has been hypothesized to inhibit regulatory enzymes related to folate and homocysteine metabolism and reduces the bioavailability of L-methylfolate.5 Hyperhomocysteinemia is an independent risk factor of vascular and endothelial dysfunction in maternal patients. Although hyperhomocysteinemia is not due to folate deficiencies alone, it can be indicative of dietary deficiencies of essential nutrients, increased catabolism, clearance and excretion of essential nutrients, hormonal influence on folate metabolism or an intrinsic metabolic disorder. Increased homocysteine levels can also increase the risk of recurrent early pregnancy loss as well as increase maternal complications. Disturbed homocysteine metabolism has also been shown to have a greater effect in women with early pregnancy losses 4,5,6,7. In the cell, 6(S)-5-MTHF (L-methylfolate) is used in the methylation of homocysteine.

The prevalence of the 677C-T mutations in the methylenetetrahydrofolate reductase gene in pregnant women was shown to be 53% 8. Studies show that enzyme activity necessary to convert folic acid to its active form (L-methylfolate) can be reduced by as much a 72% in patients with the 677C-T mutation in the methylenetetrahydrofolate reductase gene 9. In certain studies, women with the 677C-T mutation in the methylenetetrahydrofolate reductase gene (MTHFR) had significantly higher risk for recurrent pregnancy loss, congenital abnormalities and other adverse pregnancy outcomes 10,11. Other MTHFR gene variants (A1298C and MTHFD) that affect folic acid bioavailability have been associated with folate metabolism and the incidence of congenital anomalies 11, 12.

Docosahexaenoic acid or DHA, a long-chain polyunsaturated omega-3 fatty acid (C22:6n-3). DHA is an indispensable component of all cell membranes and is incorporated in high concentrations in the membrane phospholipids of brain and retina15. The DHA in NeevoDHA® comes from a vegetarian source (algae), not from fish, grown in an FDA-inspected facility16.

Contraindications Known hypersensitivity to any of the components in this product is a contraindication.

Warnings Ingestion of more than 3 grams per day of omega-3 fatty acids has been shown to have potential antithrombotic effects, including bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Adverse Reactions While allergic sensitization has been reported following both oral and parenteral administration of folic acid, allergic sensitization has not been reported with the use of Metafolin®.

Drug Interactions Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. While the concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness, no such decreased effectiveness has been reported with the use of Metafolin®. Capecitabine (Xeloda®) toxicity may increase with the addition of leucovorin (5-formyltetrahydrofolate) (folate).

Patient Information NeevoDHA should only be used under medical supervision.

NeevoDHA® is certified kosher by Triangle K and Associates.

Dosage and Administration Usual adult dose is 1(one) gelatin capsule daily or as directed by your physician.

How Supplied Available as a blue, soft gelatin capsule with “Neevo DHA” imprinted on one side in white ink. Commercial product (0525-2030-30) is supplied in bottles of 30 capsules. Sample product (0525-2030-04) is supplied in bottles of 4 capsules.

Commercial Product (30 capsules) 0525-0621-30* Sample Product (4 capsules) 0525-0621-04* Professional samples-not for sale * Pamlab, LLC does not represent this product code to be a National Drug Code (NDC) number. Instead, Pamlab has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.

Storage Store at controlled room temperature 15oC to 30oC (59oF to 86oF) (See USP). Protect from light and moisture. Dispense commercial product in original container. Dispense sample product in original container.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Patents Some or all of the following patents may apply: U.S. Patent No. 6,207,651 U.S. Patent No. 6,254,904 U.S. Patent No. 6,297,224 U.S. Patent No. 6,528,496 and other pending patent applications.

U.S. Patent No. 5,563,126 U.S. Patent No. 5,795,873 U.S. Patent No. 5,997,915 U.S. Patent No. 6,011,040

References 1. Troen A, et al. Unmetabolized folic acid in plasma is associated with reduced natural killer cells cytotoxicity among postmenopausal women. J Nutr 2006; 136:189-194 2. Wu D, Pardridge W. Blood brain barrier transport of reduced folic acid. Pharmaceutical Research 1999; 16(3):415-19.

3. Reynolds E. Benefits and risks of folic acid to the nervous system. J Neurol Neurosurg Psychiatry 2002; 72:567-571.

4. Stroes E, van Faasen E, Circ Res 2000;86:1129-34.

5. Willems FF et al. BR J Pharmacol 2004;141(5):825-30.

6. Wen S, et al. Folic acid supplementation in early second trimester and the risk of preeclampsia. Am J Obstet Gynecol 2008; 198:45.e1-45.e7.

7. Nelen W, et al. Homocysteine and folate levels as risk factors for recurrent early pregnancy loss. Obste Gynecol 2000; 95:519-24.

8. Tamura T, Picciano M. Folate and human reproduction. Am J Clin Nutr 2006; 83:993-1016.

9. Vollset S, et al. Plasma total homocysteine, pregnancy complications, and adverse pregnancy outcomes: the Hordaland Homocysteine Study. Am J Clin Nutr 2000; 71:962-8.

10. Molloy A, et al. Thermolabile variant of 5,10-methylenetetrahydrofolate reductase associated with low red-cell folates: implications for folate intake recommendations Lancet 1997; 349: 1591–93 11. Ulrich CM, et al. Pharmacogenetics of methotrexate: toxicity among marrow transplantation patients varies with the methylenetetrahydrofolate reductase C677T polymorphism. Blood 2001; 98: 231–234.

12. Kirke P, et al. Impact of the MTHFR C677T polymorphism on the risk of neural tube defects: case control study. BMJ 2004; 328:1535-1536.

13. Botto L, et al. 5, 10-methylenetetrahydrofolate Reductase gene variants and congenital anomalies: a HuGE review. Am J Epidemiol 2000; 151:862-77.

14. Gos M, et al. Genetic basis of neural tube defects. J Appl Genet 2002; 43(4):511-524.

15. Krauss-Etschmann S, et al. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr 2007; 85:1392-400.

16. Referenced by Martek Biosciences Corporation, Columbia, Maryland USA Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany.

Treating Periodontal Disease Does Not Improve Pregnancy Outcomes Treating periodontal disease during pregnancy does not lower the rate of infants with low birth weight or other adverse pregnancy outcomes, according to the results of a recent analysis of studies (Polyzos NP, et al. BMJ. 2010; 341:c7017).

A team of researchers from the United States, the United Kingdom, and Greece examined the outcomes of pregnant women with periodontal disease enrolled in 11 randomized, controlled trials that compared scaling and root planing versus no treatment.

Of the 5 trials that were of high methodologic quality, treatment for periodontal disease had no significant effect on the overall rate of preterm births. In addition, treatment did not significantly decrease the rate of infants born with low weight, spontaneous stillbirths/abortions, or overall adverse pregnancy outcomes.

FDA Requests More Clinical Trials for Latest Weight-Loss Drug Candidate

Distributed By PAMLAB, L.L.C. Covington, LA 70433 Manufactured by Accucaps Industries Ltd., Windsor, Ontario N9C 3R5 Made in Canada PC-0053

remain within the normal range in women using injectable and oral contraceptives, new data show (Berenson AB, et al. Obstet Gynecol. 2011;117: 41-47). Despite the slightly higher levels of glucose and insulin observed in women using depot medroxyprogesterone acetate (DMPA), these increases did not exceed normal ranges.

The researchers measured fasting glucose and insulin levels in 703 white, black, and Hispanic women using DMPA, oral contraceptives, or nonhormonal birth control. Measurements were taken at baseline and every 6 months for a period of 3 years, and demographic and behavioral questionnaires were completed by patients every 6 months.

Although glucose and insulin levels remained within the normal ranges for all the women, DMPA users had steady, although slight, increases in serum glucose levels; however, these levels tapered off after 30 months. Serum insulin levels increased for the first 18 months of the study for DMPA users and then reached a plateau.

Obese and overweight women who used DMPA had more marked increases in glucose and insulin levels than their normal-weight counterparts, but their levels were also within the normal range.

Revised 02/22

The pursuit of pharmacologic treatments for weight loss has suffered several blows last October, when 2 diet drugs were rejected and another was pulled from the market by the US Food and Drug Administration (FDA). Last December, however, a positive recomContinued on page 27

10

February 2011 l VOLUME 3, NUMBER 1

Clinic Profile

The Valley Hospital Fertility Center... to go to the NYU Fertility Center for their egg retrieval and embryo transfer.

In 2006, our new state-of-the-art embryology lab and facility opened in Paramus, NJ, so now we are able to do our own retrievals, transfers, and all the other in vitro fertilization (IVF) procedures. We still utilize NYU physicians and embryologists, but the nurses and the rest of the staff are from the Valley Hospital.

When we have a new hire, a couple of weeks into orientation, if the nurses do not feel that it is a fit, they will say so.

They give their opinions and always give the benefit of the doubt, but they are a very strong-knit group.

Do you keep in touch with the families after delivery?

What is your current success rate?

We are doing approximately 300 IVF cycles a year. In addition to traditional IVF cycles, we offer gestational carrier options, donor egg, oocyte cryopreservation, and fertility preservation. On any given day, we have between 20 and 40 patients who go through monitoring.

The Society for Assisted Reproductive Technologies examines data from various US IVF clinics and lists it on their website (www.SART.org). In comparing these data, our medical director, Ali Nasseri, MD, PhD, found that across 4 categories of women undergoing IVF, our center had the highest overall rates for implantation and pregnancies resulting in a live birth in women under age 35 years.

Also, a website that provides a listing of all fertility centers by region and uses certain criteria to rank centers (ivfreports.org), rated our center number 1 in the Middle Atlantic region and number 9 in the country for the past year.

Who comprises your staff?

We have 3 physicians. In 2008, Dr Nasseri, our medical director, was featured on the cover of New Jersey Monthly magazine for being named one of the top doctors that year. Dehan Chen, MD, is our assistant medical director, and Sheeva Talebian, MD, FACOG, is our female physician. They are all also on the staff of NYU, but basically their home is at our center. They do not do treatment at NYU. We use NYU for treatment protocols and embryologic protocols, and this allows us to incorporate information from a very respected center. The same goes for the 3 full-time embryologists, who are all NYU-trained embryologists.

We have 6 nurses, 3 medical assistants, and 3 laboratory technicians in the andrology laboratory and in the endocrine laboratory. We have 3 fulltime financial counselors, and about 3 support staff to help with the daily routine of registration and scheduling.

Do the nurses and doctors work closely together?

Our nurses and physicians work together and have a team approach. For example, every week we have something called IVF review. The nurses prepare

Continued from page 1

At our center, the nurses are very up-to-speed on the cultural traditions of our patients.

—Margaret M. Robinson, RN

the charts for the patients who are going to be starting an IVF cycle within the next 1 to 2 weeks, and the nurses and the physicians all sit in the big room and view a big monitor so that we can pull up patients’ electronic medical records (EMRs) and review each patient who is going to start an IVF cycle.

We go through the patient’s history and look at what the protocol was. There is a lot of input as to how she is going to proceed and what medication she should be receiving. If the doctor feels that the patient needs to take a certain medication but her insurance precludes that, then the nurse will say, “She needs to be on X, Y, or Z.” There is a very strong communication process that goes on.

The nurses and the physicians in this office respect each other very much.

There is none of the conventional hierarchy, so to speak. We have true mutual respect for one another.

One of the things that makes us a bit different from other centers, perhaps, is that the nurses all have their own style, but they all work very well with every physician, so instead of working with the same physician all the time, the nurses rotate through, so they all can get an idea of how the physician practices, and the decision-making process.

Most of our nurses come from labor and delivery, postpartum backgrounds, although we do have some with a medical/surgical background.

The nurses are very proactive when we hire a new nurse. They are all part of the interview process. As director of the center, I interview the candidate, but then the other nurses ultimately interview them. They have to work with the new person, so they have a lot of input into the decision-making process.

We have what we call “Baby Jubilee” every year in May. Originally, it used to be every baby that was born with us, but now that we have been in practice 10 years and over 1000 babies, we invite patients and their families from the present to 4 years back who have had babies with us. We all gather in a big catering hall; families bring their babies, and I hire a photographer, who takes a free family portrait when they arrive.

They are all so cute—the parents are dressed up, and the babies are all dressed up. They have a beautiful buffet dinner and they see the nurses and physicians, and they show off their babies. It is a very nice event for all.

What are some of the unique characteristics of your patient population?

Most of our patients are from the Bergen County area, which has a middle– to upper–middle-income population, even a higher-income class population in some sections. That is where we initially started. We have extended our catchment area into upstate New York. Recently, we have started to go a little bit farther south, into Passaic and Morris counties.

We have a diverse population. We are proud to serve a large patient population of Orthodox Jews who come to us for inseminations. Culturally, for this patient population, reproduction is associated with many religious traditions. Our physicians work with rabbis in the area to assure them that cultural considerations are taken into account before an insemination procedure or an IVF cycle. In addition, at our center, the nurses are very up-to-speed on the cultural traditions of our patients.

We also serve Muslim and Indian patients, but we do not have a large Hispanic population. We have maybe 2 or 3 Spanish-speaking patients.

Our center itself is very warm. In our patient satisfaction surveys, patients are always telling us how comfortable it is, and that they feel very comfortable coming here.

Do you have same-sex couples?

We have quite a few same-sex couples, in all different kinds of configurations. We have single women using donor sperm; we have 2-women couples,

of whom one is going to carry and the other one is going to use her eggs, and they will get donor sperm; or we will get 2 male patients who need a carrier and a donor. We have quite a few different configurations, because in New Jersey, we do have civil unions. New Jersey is a mandated state. If people are domestic partners, usually they are on each other’s insurance. But we still have about 30% of the patients who are self-pay; even in a mandated state, not everyone is covered by insurance.

How do your EMRs benefit the patients?

We have a room we call the “war room,” where the nurses congregate.

Even though we have an EMR system that holds all the patient information, we have a big board that gives us the ability to track where our patients are in their cycle, how many patients are due to start on a certain day, the retrievals, the transfers, the pregnancy outcomes, and the type of cycle that they are, so that anybody can go in there at any time and see where a patient stands.

Not only do they look at the medical record but they can also look at this board and understand what is going on with the patient.

Regardless of who answers the phone, whether it is a billing, a nursing, or a scheduling question, the nurse who answers that call can pull up that patient’s EMR and give a full response.

One of my pet peeves is when a patient calls and someone from the office says, “I really don’t know what is going on.” It gives that patient a sense of insecurity and lack of confidence if they call and someone does not know what is going on with their cycle, because fertility patients believe that they are the only one in cycle.

We still have a basic paper chart, which includes a patient’s identification—a copy of their driver’s license, passport, or whatever photo identification we are using—and a copy of their insurance card. We have patient demographics in the paper chart and in the EMR. Right now, our laboratory results and patient consent forms are going into the paper chart. We are working to have an interface between the EMR and the laboratory company so that we could get rid of the paper laboratory results, and we hope to get the patient consent form into the EMR by the end of 2011.

We have superior success rates, stateof-the-art technology, and extremely personal and individualized care. I could extra copy not be more proud of our program and I have every expectation that it will continue to grow in the coming years. ■

February 2011 l VOLUME 3, NUMBER 1

11

Women’s Health

Sexual Function Improves Significantly After Laparoscopic Pelvic Prolapse Repair

By Caroline Helwick

L

aparoscopic sacrocolpopexy (mesh placement for the treatment of pelvic prolapse) had a significant positive impact on sexual function 1 year after surgery, according to a study presented at the 2010 Global Congress of Minimally Invasive Gynecology, Las Vegas.

“Most patients were avoiding sex because of vaginal bulge, but after the surgery this rate dropped to less than 4%,” said Charbel Salamon, MD, FACOG, Division of Urogynecology and Pelvic Reconstructive Surgery, Atlantic Health System, Morristown, NJ. Abdominal sacrocolpopexy is the gold standard operation for pelvic organ prolapse based on efficacy and long-term durability, but little has been known about sexual function after the procedure. Most studies have been done on patients who underwent surgery via the open abdominal route or have used nonvalidated outcome measures, he said.

Urinary Incontinence Sexual Questionnaire (PISQ-12). This includes 12 questions covering emotional, physical, and partner-related aspects of sexual function. Each question has ordinal responses from 0 to 4, based on a Likert scale.

Scores range from 0 to 48, with higher scores indicating better sexual function.

Responses to individual questions from the physical domain of the PISQ-12 were also analyzed. Patients and the research nurse were blinded as to the graft material throughout the study period.

“We observed a significant improvement in total PISQ-12 in both groups,” Dr Salamon reported. Responses for the 2 mesh types were similar; therefore, the groups were combined for the final analysis.

The mean score at baseline was

Table Sexual Function Before and After Laparoscopic Sacrocolpopexy Sexual function

Before surgery 1 year after surgery

Total PISQ score

33.3

37.4

Pain during intercourse

47.4

26.3

Urinary incontinence during intercourse

27.0

2.7

Fear of incontinence restricts intercourse

23.7

7.8

Avoidance of sex because of vaginal bulge

68.4

3.9

PISQ indicates Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire.

approximately 33 for both groups; both were significantly different from baseline scores. The responses for the 2 groups were combined, and the individual variables are shown in the Table.

The addition of a suburethral sling or a perineorrhaphy at the time of the pro-

cedure did not impact the 1-year sexual function, Dr Salamon said.

“These patients were quite sexually active before surgery and even with this, there was a significant improvement in scores after surgery,” Dr Salamon noted. ■

Infants Grasp Words, Meanings Same Way as Adults

E “Most patients were avoiding sex because of vaginal bulge, but after the surgery this rate dropped to less than 4%.”

—Charbel Salamon, MD, FACOG

Dr Salamon and colleagues compared sexual activity before and 1 year after laparoscopic sacrocolpopexy in 120 women who received one of 2 types of mesh materials used in the procedure.

The study was completed by 115 patients, of whom approximately 75% were postmenopausal and 85% still had a uterus; 25% of them had previous prolapse surgery. At 12 months, the vast majority of patients reported improvement in prolapse.

Assessment of Sexual Function To assess sexual function, the investigators used the Pelvic Organ Prolapse/

12

ven before they speak their first words, infants are not only able to understand many words, they also process them via the same neural mechanism used by adults, as suggested by brain imaging techniques (Travis KE, et al. Spatiotemporal neural dynamics of word understanding in 12- to 18-month-old infants. Cereb Cortex.

2011 Jan 5. Epub ahead of print).

Researchers used magnetoencephalography and other imaging techniques on 12 infants, aged 12 to 18 months, to determine whether they use the same brain functions as adults to process words and meanings (Photo).

For the first part of the study, infants listened to words, along with randomly interspersed sounds with no meaning, so that researchers could evaluate whether the infants were able to differentiate between the two. In the second part of the study, infants listened to a series of words that were each presented twice—once preceded by a picture of the object that corresponded to the word, and once by a picture of an object that did not match the word.

Results showed that the infants experienced a brain response in the left frontotemporal areas, where word meaning is processed in the adult brain, when exposed to mismatched words and images, suggesting that the infants possess a “mental database” of word meanings. ■

February 2011 l VOLUME 3, NUMBER 1

This image shows estimated brain activity from 4 infants, ages 12-15 months. They listened to familiar words and to sounds with similar acoustic properties of words but with no actual meaning. Bright colors indicate the brain areas that respond most strongly to words or noise. Words evoked widespread activity in left frontotemporal brain areas, with only some activity in right hemisphere regions. By comparison, noise sounds evoked weaker responses in these areas, suggesting that the infant brain is capable of distinguishing between speech and nonspeech sounds. Follow-on experiments in this study suggest that these regions may also be important for helping infants to understand the meaning of these words.

Copyright © Department of Neuroscience, UC San Diego School of Medicine. Used with permission.

Meetings

Upcoming Meetings FEBRUARY

ACOG 59th Annual Clinical Meeting

American College of Nurse-Midwives

International Society for the Study of Women’s Sexual Health

4/30-5/4 Washington, DC Contact: acm@acog.org www.acog.org/acm/

5/24-5/28 San Antonio, TX Contact: (240) 485-1800, info@acnm.org http://am.midwife.org

6/17-6/19 Washington, DC Contact: (847) 517-7225, info@smsna.org

MAY

JUNE

AWHONN Convention

American Urological Association

Midwest Reproductive Symposium

5/14-5/19 Washington, DC Contact: (800) 908-9414 www.aua2011.org

6/10-6/11 Chicago, IL Contact: (888) MBM-MTGS www.mwrs.org

6/25-6/29 Denver, CO Contact: (800) 673-8499, customerservice@awhonn.org www.awhonn.org

2/10-2/13 Scottsdale, AZ Contact: (847) 517-7225 www.isswsh.org

Survival Skills for the 21st Century Gynecologist 2/19-2/21 New York, NY Contact: (888) 207-9105 www.worldclasscme.com

Cancer Survivorship and Sexual Health Symposium

AWHONN California Section 2/24-2/26 Berkeley, CA Contact: (800) 673-8499, customerservice@awhonn.org www.awhonn.org

MARCH Society of Gynecologic Oncologists Annual Meeting on Women’s Cancer 3/6-3/9 Orlando, FL Contact: (866) 229-3691 www.sgo.org

SUNA Annual Symposium 3/10-3/12 New Orleans, LA Contact: (888) TAP-SUNA, suna@ajj.com www.suna.org

Society for Gynecologic Investigation 3/16-3/19 Miami Beach, FL Contact: (202) 863-2407, lgildersleeve@sgionline.org www.sgionline.org

World Symposium on Endometriosis 3/24-3/261 Atlanta, GA Contact: (404) 851-6795, info@endometriosisatlanta.com www.endometriosisatlanta.com

American College of Osteopathic Obstetricians & Gynecologists 3/27-3/31 Orlando, FL Contact: (817) 377-0421 www.acoog.com

APRIL Women’s Health 2011: The 19th Annual Congress 4/1-4/3 Washington, DC Contact: (914) 740-2100, nrivera@bioconferences.com www.bioconferences.com/wh

Ovarian Cancer?

OVA1TM – the 1st FDA cleared blood test to help evaluate an ovarian mass for malignancy prior to a planned surgery.*

International Female Urology and Urogynecology Symposium 4/7-4/9 Las Vegas, NV Contact: (502) 574-9023, kkirchner@hqtrs.com www.urogyn-cme.org

Pacific Coast Reproductive Society 4/13-4/17 Rancho Mirage, CA Contact: (541) 549-1607, info@pcrsonline.org www.pcrsonline.org

The North American Society for Pediatric and Adolescent Gynecology 4/14-4/16 Chicago, IL Contact: (202) 863‐1648 www.naspag.org

Contemporary Trends in Perinatal Medicine 4/16-4/17 Atlanta, GA Contact: (404) 851-6795, info.ctpm@northside.com www.ctpm-northside.com

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.

New England Fertility Society 4/29-4/30 Westbrook, CT Contact: (978) 640-9176, michellepicher@nefs.org www.nefs.org

ova-1.com February 2011 l VOLUME 3, NUMBER 1

13

Women’s Health AWHONN HIGHLIGHTS

Ultrasound during Pregnancy: At the Bedside and in the Office

By Caroline Helwick

N

urses wishing to expand their practice scope with regard to ultrasonography during pregnancy had the opportunity to receive some guidance from Marilyn Stringer, PhD, WHNP-BC, RDMS, FAAN, Professor, Women’s Health Nursing, University of Pennsylvania, and Clinical Educator, University of Pennsylvania Health System School of Nursing, Philadelphia, during her presentation at the 2010 meeting of the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN).

Dr Stringer, who is also Associate Editor of the Journal of Obstetric, Gynecologic, & Neonatal Nursing, said that nurses have good reason to expand their ultrasound assessment skills.

“Timely intrauterine fetal assessment may be life-saving and can lead to more appropriate management plans,” she said. “It’s often the nurse who is there when the patient presents with a problem. Being able to put a scanner on the belly will often give you an answer.”

The AWHONN practice guidelines recommend that nurses have 8 hours of didactic instruction and demonstrate clinical competence in this area.

“When you do, you need documentation of how you learned,” she said, “including what courses, sessions, and so forth that you attended. It’s no different from documenting your education, for example, in fetal monitoring.”

Nurses can determine if they can conduct bedside ultrasound by first

Case Study

“Most states do not forbid nurses from doing this, and AWHONN’s guidelines support nurses doing ultrasonography in their own practice settings.”

—Marilyn Stringer, PhD, WHNPBC, RDMS, FAAN

checking their state’s guidelines, which vary, and the guidelines of their professional organization. “Most states do not forbid nurses from doing this, and AWHONN’s guidelines support nurses doing ultrasonography in their own practice settings,” she noted.

Proper Use of Ultrasound Dr Stringer described the indications for ultrasound in the OB/GYN

A 20-year-old nulliparous patient has not had a menstrual period in more than 1 month. Her last menstrual period was 6 weeks ago, and she has a positive home pregnancy test. She presents complaining of pain, spotting, and cramping. The physical examination results are within normal limits, but it is not possible to know the gestational age without an ultrasound.

The 5 possible findings include: • Normal pregnancy (size = dates) • She is 5 weeks pregnant and this is “anniversary bleeding” • She is 8 weeks pregnant and has a low-lying placenta • She is 6 weeks pregnant and has a nonviable embryo or empty sac • She has an ectopic pregnancy rather than an intrauterine preg-

nancy, which would require immediate action.

Ultrasound reveals a gestational sac (sometimes seen as early as the fourth week) that is evenly rounded with a double-ring sign, measuring 2.5 mm; a nicely rounded yolk sac (usually appearing during the fifth week); a fetal pole (appearing just after the sixth week); and a fetal pole/crown rump measurement of 5 mm. Fetal heart tones (which can be heard after the fifth week with vaginal ultrasound) are present.

The nurse determines that the pregnancy is normal. The size and date correspond, the placenta is anterior, and the volume of amniotic fluid is normal.

The patient is able to be quickly reassured in the office and sent home.

setting. (The updated information is in bold type.)

Ultrasound in gynecologic and reproductive medicine is meant to provide targeted, rather than diagnostic, data. It is used to evaluate ovarian follicles, for intrauterine device placement, to contribute to postvoid assessments, and to evaluate endometrial thickness.

Obstetric first-trimester ultrasound is performed to define the number and measurement of the yolk sac, gestational sac, and embryo/fetus; to determine fetal cardiac activity; and to differenti-

ate intrauterine from extrauterine pregnancy. It also provides adjunctive visual guidance for a number of interventions in the first trimester.

In the second and third trimesters, ultrasound determines fetal number, location, and presentation; describes fetal cardiac activity; defines placental location; measures amniotic fluid volume; is part of the biophysical profile; estimates fetal age and weight; measures cervical length; and serves as an adjunctive visual guide to certain interventions. ■

Botox Relieves Chronic Pelvic Pain

I

njections of botulinum toxin type A (Botox) into the pelvic floor provided significant relief from chronic pelvic pain and pressure in an openlabel study reported by Australian investigators at the 2010 Global Congress of Minimally Invasive Gynecology.

“The effect was maintained up to 26 weeks, and repeat injections were also effective,” said Sherin K. Jarvis, MD, of the Royal Hospital for Women, Randwick, New South Wales.

Dr Jarvis reported the results of the study of 37 women, aged 21 to 52 years, with objective pelvic floor muscle hypertonicity and at least a 2-year history of pelvic pain. The women received bilateral injections of 100 IU of Botox into the levator ani muscles under conscious sedation.

14

Chronic pelvic pain is common, and often remains undiagnosed and ineffectively treated, she noted. Although physiotherapy should be the first-line treatment, there are women refractory to all conservative measures, and they are good candidates for Botox, she said.

“These patients had been through a lot,” she noted. “They had undergone all conservative measures, all medical interventions, and many surgeries. The mean number of surgeries, in fact, was 6.

This was a treatment of last resort.”

Dysmenorrhea, dyspareunia, dyschezia, and nonmenstrual pelvic pain were assessed using a visual analog scale (VAS). Pelvic floor pressure was measured by vaginal manometry at 0, 4, 12, 26, and 52 weeks after each injection.

A total of 26 women required only 1

February 2011 l VOLUME 3, NUMBER 1

injection; 20 of them had a marked improvement, with no need for additional interventions, whereas 6 had

“These patients had been through a lot....This was a treatment of last resort.”

—Sherin K. Jarvis, MD

minimal improvement. For 11 women, ≥2 injections were required for effect; the maximum number of injections was 6, Dr Jarvis reported.

The effect of Botox was long-lasting, with a median time to reinjection of 33.4 weeks among responders. Some respon-

ders had relief for up to 123 weeks.

Significant reductions occurred in dyspareunia VAS, from 52 to 32, and in nonmenstrual pelvic pain VAS, from 41 to 24. Pelvic floor pressure was significantly reduced, from 45 to 31 cmH2O, with maximal benefit observed 4 weeks after the index injection.

No significant differences in dysmenorrhea or dyschezia (which was rare) were observed, which Dr Jarvis said was not surprising, “since this is pain of uterine origin.” No major adverse events occurred.

Dr Jarvis noted that the cost of 1 treatment is about $500 (Australian), which is not reimbursed. “Patients pay out of pocket for this, and they are happy to spend this money to get pain relief,” she said.—CH ■

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.

Printed in USA

06968

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

Psychosocial View of Breech Presentation

By Caroline Helwick

B

reech presentation may be best understood via an Eastern psychosocial paradigm, based on a study that earned the Best Poster Award at the Association of Womenâ&#x20AC;&#x2122;s Health, Obstetric and Neonatal Nurses 2010 meeting.

Caroline Peterson, DC, PhD, MPH, of Oregon Health and Science University, Portland, told the OB/GYN

Nurse-NP/PA that her experience with many mothers confirms her findings.

This case-control study included 114 new mothers who completed a sociodemographic survey; 75 of them (52 cephalic and 23 breech) also had a 2hour in-depth interview.

Dr Peterson found that although mothers of breech infants loved their

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February 2011 l VOLUME 3, NUMBER 1

infants no less and had no more stress than did mothers with cephalic presentations, coping styles were different.

Mothers with breech pregnancies tended to be very analytical, busy, and fearful of pregnancy outcomes or parenting.

They had higher salaries, were better educated, and had higher social prestige. They also tended to lack the cop-

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â&#x20AC;&#x153;Tell the mother she can help change the breech presentation by creating an engaging relationship with her infant.â&#x20AC;? â&#x20AC;&#x201D;Caroline Peterson, DC, PhD, MPH

ing mechanisms of â&#x20AC;&#x153;flexibility and pragmatism,â&#x20AC;? she said. â&#x20AC;&#x153;These mothersâ&#x20AC;Śwere performanceoriented and already overextended.

Having a baby seemed like something they would take care of later. They were also more fearful about birth and parenting.â&#x20AC;? Mothers of cephalic infants had better coping skills and a greater sense of connection with their infants.

Western versus Eastern Models The incidence of breech presentation is similar cross-culturally (2%-4%), but Western and Eastern cultures have different explanatory models for it. The West attributes breech presentation to mechanical faults of the baby/mother, whereas Chinese and ayurvedic medicine view turning to cephalic presentation as a fetal developmental stage that requires the participation of the mother and baby.

In the Eastern model, the breech baby is not ready to become autonomous, perhaps because the mothers are â&#x20AC;&#x153;stressed outâ&#x20AC;? and â&#x20AC;&#x153;fearful,â&#x20AC;? she said. â&#x20AC;&#x153;We should consider the possibility that turning to cephalic presentation is an important developmental stage initiated by the baby,â&#x20AC;? Dr Peterson suggested. â&#x20AC;&#x153;Another interesting possibility is that breech presentation is behavioral evidence of intrauterine ambivalent attachment, since these mothers share personality traits and parenting techniques with mothers of ambivalently attached babies.â&#x20AC;?

In the West, breech presentation is managed by external cephalic version or cesarean section. In the East, the goal is to remove barriers to turning.

Chinese medicine uses the herb moxibustion, which is as likely to turn the baby as external cephalic version. The herb is heated and applied to the bladder meridian to induce smooth flow of blood and â&#x20AC;&#x153;chiâ&#x20AC;? (ie, life energy).

Obstetric nurses can also influence presentation. â&#x20AC;&#x153;Donâ&#x20AC;&#x2122;t assume this is a mechanical problem you can do nothing about,â&#x20AC;? she said. â&#x20AC;&#x153;Tell the mother to talk to her baby, include her baby in her life right now. Tell the mother she can help change the breech presentation by creating an engaging relationship with her infant from this point forward. I have worked with many such mothers and I can tell you, this works.â&#x20AC;? â&#x2013;

The Cancer Patient ESMO HIGHLIGHTS

Molecular Targeted Cancer Therapies Linked to Sexual Dysfunction Effect Greater in Women than in Men

By Alice Goodman

M

olecular targeted therapies (also known as biologic therapies)—considered a major advance in treating many types of cancer—have a negative impact on the quality and intensity of sexual function and satisfaction, according to a study presented at the 2010 European Society of Medical Oncology (ESMO) Congress.

Only few studies have explored this important area, according to lead author Yohann Loriot, MD, Institute Gustave Roissy, Villejuif, France. “The new molecular targeted therapies have been available for about 6 or 7 years, and researchers and physicians have observed some side effects not often seen with chemotherapy, such as skin rash and gastrointestinal toxicity. The impact of these treatments on sexuality of patients with cancer is poorly understood and is generally not assessed in clinical trials,” Dr Loriot said, adding that patients are often reluctant to talk to physicians about sexuality.

The study enrolled 51 patients—40 men and 11 women—with advanced cancer who were taking molecular targeted therapies (ie, sunitinib, sorafenib, temsirolimus, everolimus, bevacizumab,

erlotinib, or cetuximab) for >3 months, with no evidence of progressive disease.

The effect on sexuality was assessed using the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI) question-

“The impact of these treatments on sexuality of patients with cancer is poorly understood and is generally not assessed in clinical trials.”

—Yohann Loriot, MD

naires. The IIEF explores erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. The FSFI explores desire, arousal, lubrication, orgasm, satisfaction, and pain.

Patients’ age ranged from 40 to 75 years; treatment duration with biologic agents ranged from 2 to 54 months.

Although 51% of respondents considered the quality of their sex lives important, many said that they were uncomfortable discussing it with their

Top 3 Cancer Threats to Women Among the numerous threats from various types of cancers, 3 in particular affect women most, as well as comprise the top causes of cancer deaths in women, according to the most recent statistics released by the Centers for Disease Control and Prevention (United States Cancer Statistics: 2007 Incidence and Mortality Report). These statistics include data provided by the National Program of Cancer Registries and the National Cancer Institutes’ Surveillance, Epidemiology, and End Results Program on the incidence of cancer.

1. Breast cancer was found to be the most common cancer among American women of all races. In addition, it is the leading cause of cancer deaths for Hispanic women, and the second leading cause of cancer deaths for white, black, Asian/

Pacific Islander, and American Indian/ Alaska Native women.

2. Lung cancer is the second most common cancer among white, black, and American Indian/Alaska Native women, and the third most common among women of Asian/Pacific Islander and Hispanic origins. It ranks highest for causing cancer deaths in US women of all races except Hispanic, for whom lung cancer is the second leading cause of cancer death.

3. Colorectal cancer is the third most often occurring cancer among white, black, and American Indian/ Alaska Native women, and the second among Asian/Pacific Islander and Hispanic women. It also ranked third among the leading causes of cancer deaths among women of all races. ■

physicians. Based on their responses, women suffer a greater negative impact on sexuality than men when treated with such therapies.

The median score for men was 40 (which is 53% of the maximum score) compared with only 8.4 (24% of the maximum score) for women. The reduction in maximal scores in sexual domains assessed by IIEF was 40% to 60% for men; the reduction in sexual domains assessed by FSFI for women was 56% to 75%.

Dr Loriot suggested that oncologists assess sexuality in clinical trials and offer patients a sexual assessment during their treatment course. Ideally, outpatient clinics could address sexual prob-

lems, or patients could be referred to a specialist when necessary.

Raphael Catane, MD, Chair of the Department of Oncology, Sheba Medical Center, Tel Hashomer, Israel, commended the investigators for addressing this poorly understood area.

“The investigators meticulously reviewed the sexual function of their patients receiving biologic agents. The results show diminished sexual drive and pleasure, but the degree and the duration, and how this compares to effects of standard chemotherapy, is not known,” Dr Catane said. “The study can be a basis for further investigation of this very important aspect of cancer therapy.” ■

FDA Recommends Removal of Breast Cancer Indication for Avastin

By Jessica A. Smith

T

he US Food and Drug Administration (FDA) recommended late in 2010 to remove the breast cancer indication for bevacizumab (Avastin), because of a review of new data indicating that the drug has not been shown to be safe and effective for this patient population; specifically, the drug does not prolong overall survival and does not sufficiently slow the disease progression to warrant its associated adverse events, which include severe hypertension; bleeding and hemorrhage; perforations in the nose, stomach, and intestines; and heart attack or heart failure.

The FDA’s accelerated approval of bevacizumab was granted in February 2008, for use in combination with another cancer drug, paclitaxel. The current recommendation to remove the drug’s indication for metastatic breast cancer came after a near-unanimous (12:1) vote by an advisory committee comprised largely of oncologists who had reviewed 4 recent studies on bevacizumab in women with breast cancer. The manufacturer of the drug is in discussions with the FDA in the attempt to reverse this recommendation.

Although bevacizumab can still be used off label for the treatment of

metastatic breast cancer, the question of whether insurance companies will cover it as an off-label use raises concerns for patients, considering the high cost of the drug.

The FDA recommends that oncologists currently treating patients with bevacizumab use their judgment in weighing the decision of whether to continue its use or switch to other therapies. Another concern involves patients who may wish to continue using this drug in the absence of other therapeutic options.

The FDA’s recommendation has also met with resistance from some oncologists and oncology groups. In October 2010, the National Comprehensive Cancer Network confirmed the indication of bevacizumab for metastatic breast cancer in its updated breast cancer guidelines, despite the acknowledgment of the “lowlevel evidence” and the limited improvements in time to progression and response rates with the drug.

By contrast, the United Kingdom’s National Institute for Health and Clinical Excellence announced in December that it would not support the use of bevacizumab for metastatic breast cancer because of insufficient evidence. ■

February 2011 l VOLUME 3, NUMBER 1

17

Pharmacy Corner

Using OTC Cough and Cold Preparations during Pregnancy

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

N

ine months is a long time to go without catching a cold.

Although it would be great to sail through pregnancy without getting sick, even a sniffle during this time can cause great discomfort. Of particular concern is the safety of over-the-

counter (OTC) medication use in the care of a pregnant woman. Because of ethical concerns, many drugs have not been—and probably will not be—adequately researched for their effects during pregnancy; therefore, most safety data available have been provided by

postmarketing surveillance reports. In 1975, the US Food and Drug Administration developed categories for appropriate use of medications during pregnancy. These categories were presented in this journal in February 2010.1 In the United States, hundreds of

thousands of babies are born yearly with birth defects. It is estimated that at least 10% of birth defects are a result of maternal drug exposure.2 This issue is further complicated by medications’ safety and efficacy being dependent on the stage of fetal development. Therefore, some Continued on page 19

Table OTC Cough and Cold Products Therapeutic category

Pregnancy categorya

Dosage

Potential concerns in pregnancy

Preferred analgesic in pregnancy

Analgesics Acetaminophen

B

325-1000 mg Q 4-6 hours prn (max 4000 mg/day)

NSAIDs (multiple)

B (1st and 2nd trimesters) D (3rd trimester)

Ibuprofen 200-400 mg Q 4-6 hours prn Avoid in third trimester (max 1200 mg/day); naproxen 220 mg Use smallest effective dose Q 8-12 hours prn (max 660 mg/day); ketoprofen 12.5 mg Q 6-8 hours prn (max 75 mg/day)

Aspirin (Anacin, others)

D

NA

Not recommended unless under direct approval and supervision of physician

Pseudoephedrine (Sudafed)

C

30-60 mg Q 4-6 hours prn (max 240 mg/day)

Oral decongestant of choice in pregnancy but avoid in first trimester Possible link to gastroschisis

Oxymetazoline nasal

C

2-3 sprays per nostril Q 10-12 hours prn (max 2 doses/day)

Nasal decongestant of choice in pregnancy Avoid use >3 days

Guaifenesin (Robitussin)

C

200-400 mg Q 4 hours prn (max 2400 mg/day)

Avoid in first trimester Possible link to inguinal hernia Questionable efficacy

Dextromethorphan (Robitussin CoughGels)

C

10-20 mg Q 4 hours prn (max 120 mg/day)

Unknown role of N-methyl-D-aspartate receptor antagonism on fetal brain growth Questionable efficacy

Salicylates

Antitussives/Expectorants

Antihistamines (Avoid in third trimester because of possible link to retrolental fibroplasias and convulsions) Brompheniramine (Dimetapp C combination product)

4 mg Q 4-6 hours prn (max 24 mg/day)

Possible link to malformations

Chlorpheniramine (Chlor-Trimeton)

B

4 mg Q 4-6 hours prn (max 24 mg/day)

Antihistamine of choice in pregnancy

Clemastine (Tavist)

B

1.34 mg Q 12 hours prn (max 2.68 mg/day)

Possible link to limb reduction defects

Diphenhydramine (Benadryl)

B

25-50 mg Q 4-6 hours prn (max 300 mg/day)

Possible stimulation of uterine contractions at higher doses; possible link to polydactyl

Triprolidine (available in certain Actifed products)

C

2.5 mg Q 4-6 hours prn (max 10 mg/day)

Possible malformations because of triprolidine or combination with pseudoephedrine

Menthol/camphor

Unknown

NA

Because of insufficient information, patient should contact physician before use

Echinacea

NA

NA

Avoid use in pregnancy

Zinc and vitamin C

Acceptable NA in appropriate doses

Miscellaneous

For cough/cold treatment, doses are higher than the recommended doses used for vitamin supplementation (eg, prenatal vitamins) Use with caution, if at all

NOTE: List not all-inclusive. aSee Reference 1.

NA indicates not applicable; NSAIDs, nonsteroidal anti-inflammatory drugs; OTC, over-the-counter; prn, as needed; Q, every.

Reprinted with permission from Wigle PR, McNeal SM. Pregnancy and OTC cough, cold, and analgesic preparations. US Pharmacist. 2006;3:33-47.

18

February 2011 l VOLUME 3, NUMBER 1

Pharmacy Corner

Using OTC Cough and Cold Preparations... drugs’ safety profiles may change during the course of a normal pregnancy.

Practitioners must weigh the benefits and risks for each patient when making a recommendation of OTC cough and cold preparations to pregnant women. Although the common cold is not a life-threatening condition, nonpharmacologic therapy should be the first recommendation made before OTC medications. Such therapy may include increasing fluid intake, rest, using humidifiers and vaporizers, nasal irrigation, saline nasal drops, and salt water gargles.

Although the availability of a drug as an OTC product demonstrates its safety for use by the general public, it does not reflect safety for use during pregnancy.

Pregnant women who are deemed appropriate candidates for self-treatment with OTC cough and cold formulations should be given general guidelines to help them choose the best product available for their symptoms.

The Table lists suitable product choices, their respective pregnancy categories and dosages, and potential concerns during pregnancy.3 In addition, patients should be advised to: • Always check all “active ingredients” in the product • Avoid combination products; products with the fewest number of ingredients should be chosen and administered at the lowest dose; this allows the patient to treat specific symptoms she is experiencing without exposing herself and the fetus to potentially unsafe ingredients she does not need • Avoid long-acting and alcohol-containing products • Not use aspirin or aspirin-containing products without the approval and monitoring of a physician, because these can cause bleeding in the mother and fetus • Use dosing on an as-needed basis and at the lowest dose possible • Try to avoid all medications during the first trimester, because the risk to the fetus is greatest during that period • Always check with her doctor or pharmacist before taking any OTC or herbal remedies, because some may

not be safe for the developing fetus or may interact with medications she is currently taking.

Although the availability of a drug as an OTC product demonstrates its safety for use by the general public, it does not reflect safety for use during pregnancy.

The methodologic challenges in study-

Continued from page 18

ing the safety and efficacy of OTC and prescription medications in pregnancy must be overcome so that risks can be identified, and this critical information can be provided to clinicians and pregnant women who are making treatment decisions during that clinically susceptible period. ■

References 1. Fernandez S. Medication use in pregnancy, what your patients need to know. OB/GYN & Infertility Nurse. 2010;2:7.

2. Wilson JG. Current status of teratology. In: Wilson JG, Fraser FC, eds. Handbook of Teratology.

New York, NY: Plenum Press; 1977:47-73.

3. Wigle PR, McNeal SM. Pregnancy and OTC cough, cold, and analgesic preparations. US Pharmacist. 2006; 3:33-47.

Midwest Reproductive Symposium & Nurse Practicum 2011 Nurse Practicum Day – June 9 • MRS – June 10-11 THE DRAKE HOTEL • CHICAGO, IL

JJoin oin y your our ccolleagues olleagues for a timely and lively discussion of issues releevant to reproductive medicine in a highly interactive e,, continuing education environment.

And, thanks to last year’s attendees for their feedback! This year’s Practicum Day includes tracked sessions for nurses new to the field and those more experienced and an afternoon ‘en groupe.’ Discounted MRS registration is included.

Some discussion and workshop topics: Age and Body W Weight: eight: A Guide for Establishing Practice Limits; Genetic Counseling and the Genetics of Infertility; OHSS: Current Trends and Treatment Options; IVF Medication Protocols; Health Maintenance for Women of Reproductive Age; Hands-on Ultrasound; Designing and Implementing Effective Studies; The Male Infertility Evaluation; Ethics and Legal Dilemmas; and more!

FACULLTY FACULTY: Y: Barr y Behr, PhD* • Angeline Beltsos, MD** • Lauri Black, MS, CGC • Judy Campisi, LPN* Susan Crockin, JD • Nidhi Desai, JD • Donald Galen, MD • Robert Gilchrist, PhD • Shalini Gunawardena, RN, BSN Karen Hammond, DNP, CRNP • Laurence Jacobs, MD • Maria Jackson, RN, MA • Keith Jarvi, MD • Sue Jasulaitis, RN, MS William Kearns, PhD* • David Keefe, MD • William Kutteh, MD • Carol Lesser, NP • Zsolt Peter Nagyy, MD, PhD Ann Scalia, RN, BSN, CNOR* • Richard Scott, MD • David Seifer, MD • Kaylen Silverberg, MD • Johan Smitz, MD, PhD Tamara TTobias, obias, ARNP *Chairperson **Executive Chairperson

LOWER REGISTRA REGISTRATION RA ATION TION FEES until March 11th: $410 includes the MRS ($250 for the Nurse Practicum Day only) FOR MORE TION about the program, accreditation, RE INFORMA ATION a and TO REGISTER: Go to www www.mwrs.org w.mwrs.org (or call 888-MBM-MTGS, ext.24).

February 2011 l VOLUME 3, NUMBER 1

19

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PROGRAM CNE003 • RELEASE DATE: FEBRUARY 20, 2011 • EXPIRATION DATE: FEBRUARY 20, 2012 ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Current Options for Prenatal Genetic Testing Sarah Keilman, MS, CGC; Lauren Isley, BS; Eric Czuprenski, BS Ms Keilman is a Certified Genetic Counselor and Mr Czuprenski is a Molecular Biologist, Genesis Genetics Institute; Ms Isley is a genetic counseling student at Wayne State University, all in Detroit, MI.

STATEMENT OF NEED Until recently, the purpose of prenatal care was to protect the health of the mother. With the increasing understanding of fetal development, the focus of screening has in recent years been expanded to include concerns for the health and development of the fetus as well as the mother.

This shift in focus and advancements in prenatal medicine has expanded the use of diagnostic and screening tests to include all pregnant women in the United States.

Over the years, the number of prenatal screening tests has increased dramatically. Clinicians involved in women’s health and infertility should be familiar with the different tests that are available, the type of tests and procedures used during pregnancy, and whether it should be performed during the first or the second trimester of pregnancy.

The sensitivity and specificity of prenatal screening tests are now higher than ever before, and the risks associated with diagnostic procedures are lower than before. Offering these tests to women during pregnancy can allow future parents and their clinicians to prepare for and address ahead of time any issues related to genetic disorders, such as Down syndrome, and ensure better prognosis for mother and child.

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 the advances in prenatal screening over the years and the reasons for administering these tests and procedures • Discuss the various prenatal screening tests and procedures available today and their benefits in identifying potential genetic disorders • Review the risks of having a child with a chromosomal disorder such as Down syndrome and why this is important in the context of prenatal genetic testing 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

20

U

ntil recently, the purpose of prenatal care was to protect the health of the mother. The current focus has been expanded to include concerns for the health and development of the fetus.1 The understanding of fetal development has increased as a result of the advancements in perinatal medicine, which allows for diagnostic and screening tests during pregnancy.

Prenatal diagnostic testing or genetic screening is available to all pregnant women in the United States.1 A number of different tests are available to an expectant mother. These include screening tests, which can better identify her personal risk of having a child with certain genetic conditions, as well as invasive diagnostic procedures that will tell her with certainty whether her child has certain genetic conditions.

Alternatively, she can choose not to test at all.

Over the years, the number of screening tests available during pregnancy has increased dramatically. The sensitivity and specificity of prenatal screening tests are now higher than ever before, and the risks associated with diagnostic procedures are lower.

Screening Tests Prenatal screening tests can be done

2. Go to www.infertilityrepronews. com 3. Select “Continuing Education” 4. Click on this article’s title from the list shown 5. Select “Click here to complete the posttest and obtain a CE certificate online” 6. Complete and submit the CE posttest and CE activity evaluation 7. Print your Certificate of Credit This activity is provided free of charge to participants.

FACULTY DISCLOSURES As a provider accredited by the California Board of Registered Nursing, Science Care must ensure balance, independence, objectivity, and scientific rigor in all its activities. All course directors, faculty, planners, and any other individual in a position to control the content of this educational activity are required to disclose to the audience any relevant financial relationships with any commercial interest.

Science Care must determine if the faculty’s relationships may influence the educational content with regard to exposition or conclusion and resolve any conflicts of interest prior to the

February 2011 l VOLUME 3, NUMBER 1

on large numbers of patients to determine who may be appropriate candidates for diagnostic testing. Screening tests generally have only moderate specificity but high sensitivity. This means that many patients will screen positive for genetic disorder, although only a fraction of them will actually have a pregnancy positive for the condition suggested by the screening. The appropriate screening test depends on the stage of pregnancy—the first or the second trimester—and the goals of the patient.

A nuchal translucency measurement alone will detect approximately 75% of fetuses with Down syndrome, trisomy 13, and trisomy 18.

First Trimester A nuchal translucency screening is performed between approximately 11 and 14 weeks gestation.1,2 It involves a specialized ultrasound to measure the pocket of fluid behind the neck of the fetus. If the nuchal translucency of the commencement of the educational activity. Disclosures are as follows: • Eric Czuprenski, BS, has nothing to disclose.

• Lauren Isley, BS, has nothing to disclose.

• Sarah Keilman, MS, CGC, has nothing to disclose.

• Norah S. Nutter, MSN, WHNP-BC, IBCLC, 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 © 2011 Science Care. All rights reserved.

fetus is larger than normal, this is a sign for a potential risk for a chromosome abnormality or a genetic disorder. A nuchal translucency smaller than 3.5 mm is considered to be normal.3 Approximately one third of fetuses with a nuchal translucency of 3.5 mm or larger will have a chromosome abnormality.1,2 A nuchal translucency measurement alone will detect approximately 75% of fetuses with Down syndrome (or trisomy 21), trisomy 13, and trisomy 18 (the latter 2 are genetic disorders that include a combination of birth defects, including mental retardation and problems involving nearly every organ system).1,2 The first trimester screening is performed between approximately 11 and 14 weeks gestation and includes a maternal blood test and an ultrasound.

The results of this combined test will modify the patient’s age-related risk to the fetus for Down syndrome or trisomies 13 and 18, using an algorithm based on 2 serum markers and an ultrasound data, as well as the nuchal translucency measurement.1 Using this algorithm, the detection rate among women younger than age 35 years is approximately 85% for fetuses with Down syndrome.1 This screening test has a false-positive rate of 5%.1 eDITOrIaL bOarD eric Czuprenski, bS Molecular Biologist Genesis Genetics Institute 5555 Conner, Suite 1100 Detroit, MI 48213 Sarah Keilman, MS, CGC Certified Genetic Counselor Genesis Genetics Institute 5555 Conner, Suite 1100 Detroit, MI 48213 Lauren Isley, bS Genetic Counseling Student Wayne State University Center for Molecular Medicine and Genetics 540 East Canfield Detroit, MI 48201 Norah S. Nutter, MSN, WHNP-bC, IbCLC Women’s Health Nurse Practitioner Magnolia OB/GYN 8203 Nigels Drive, Suite 100 Myrtle Beach, SC 29572

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The full/serum integrated screening is a 2-part test that includes a maternal blood test and an ultrasound between approximately 10 and 14 weeks gestation and a second maternal blood test at approximately 16 weeks gestation. After the second blood test, the patient will receive a combined risk assessment result for Down syndrome, trisomy 18, spina bifida, and Smith-Lemli-Opitz syndrome (a rare genetic disorder).1 This integrated screening has the best detection rate (approximately 96%) and the lowest false-positive rate (1%-5%) of all the maternal serum screening tests.1 The stepwise sequential screening is an initial first-trimester test consisting of a blood test and a fetal ultrasound.1 The blood test measures the levels of free beta-hCG (human chorionic gonadotropin) and pregnancyassociated plasma protein A. The fetal ultrasound measures the fetal nuchal translucency.1 If the patient’s risk (for a potential risk for the fetus) is increased based on this first-trimester portion of the test, the patient will be offered a diagnostic procedure. If the risk is decreased based on the first-trimester portion of this test, the patient will proceed with a second-trimester blood test. The detection rate for Down syndrome with this test is approximately 95%.1 Second Trimester The quad screening is performed between approximately 15 and 21 weeks gestation and involves a single maternal blood test. Using 4 different serum markers, the test clarifies the patient’s age-related risk of the fetus having Down syndrome, trisomy 18, spina bifida, or Smith-Lemli-Opitz syndrome. For women younger than age 35 years, the detection rate for Down syndrome is slightly lower (approximately 81%) than with the first-trimester screening.1 A fetal ultrasound uses sound waves that are transmitted through the maternal abdominal wall to create a black and white image of the fetus. It is used to establish pregnancy dating and viability; assess for the presence of fetal anomalies; and identify placental, uterine, or amniotic fluid abnormalities.

Fetal ultrasound may not detect all fetal anomalies; it is estimated that between approximately 50% and 75% of fetuses with Down syndrome will have a visible ultrasound abnormality.4-6 More than 95% of fetuses with trisomy 18 and spina bifida will exhibit an abnormality on the ultrasound.4-6 Ultrasounds also provide a thorough image of how the fetus is developing and allow for the fetus to be focused on independently for diagnostic testing and screening.1

Prenatal Screening and Diagnostic Options for Detecting Fetal Table Down Syndrome Trimester in which test can be done

Approximate detection rate for Down syndrome, %

Nuchal translucency

First

75

First trimester screening

First

85

Full/serum integrated screening

First/second

96

Stepwise sequential screening

First/second

95

Quad screening

Second

81

Fetal ultrasound

Second

50-75

First

>99

Second

>99

Prenatal screening options

chorionic villus sampling; therefore the procedure is called “noninvasive.” The technology is in its very beginning stages and is not yet used in the clinical setting; however, it may become a frequently used diagnostic option in the future.7

Screening test

Genetic Testing for Women Carrying Multiples For women who carry multiple gestations, diagnostic options are more limited. Far fewer data are available concerning the risk of fetal loss when amniocentesis or chorionic villus sampling is performed on more than 1 fetus.

One study suggests that the risk is not higher than the background loss rate of twins earlier than 24 weeks gestation, which is approximately 1.1%.7,9

Diagnostic procedure Chorionic villus sampling Amniocentesis

NOTE: Noninvasive prenatal diagnosis is emerging but no data are currently available.

Sources: American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 77: screening for fetal chromosomal abnormalities. Obstet Gynecol.

2007;109:217-227; Cameron M, Moran P. Prenatal screening and diagnosis of neural tube defects. Prenat Diagn. 2009;29:402-411; American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 101: ultrasonography in pregnancy. Obstet Gynecol. 2009;113:451-461.

Diagnostic Procedures A diagnostic procedure is meant to diagnose a particular condition, such as Down syndrome or cystic fibrosis. A positive test result from a diagnostic procedure tells the patient for certain if the fetus is affected with the suspected condition, which was detected with a screening test.

Currently, 3 diagnostic procedures are available for the detection of genetic abnormalities in the fetus—amniocentesis, chorionic villus sampling, and noninvasive prenatal diagnosis.

Far fewer data are available concerning the risk of fetal loss when amniocentesis or chorionic villus sampling is performed on more than 1 fetus.

Amniocentesis can be performed in the second trimester, typically between 15 and 20 weeks gestation.7 This procedure can be used to determine fetal karyotype (chromosomes), with more than 99% accuracy.7 A needle is passed through the abdomen, uterine wall, and amniotic sac. Approximately 1 to 2 tablespoons of amniotic fluid are removed with a syringe. The fetal cells from the amniotic fluid are then ana-

lyzed for chromosome abnormalities or other specific conditions. The amniotic fluid can also be analyzed for 2 different proteins that screen for spina bifida.

The risk for complications that could lead to miscarriage with this procedure is approximately 1 in 200.7 Each center will typically quote their own individual procedure risk.8 The American College of Obstetricians and Gynecologists (ACOG) stated that the procedurerelated loss rate may be even lower than 1 in 500 when performed by an experienced individual.7 Chorionic villus sampling can be performed after 9 full weeks of gestation.

This test can be used to determine a fetal karyotype, with more than 99% accuracy rate.7 The procedure is typically performed transcervically but can also be done transabdominally. A small sample of placental tissue is obtained, using gentle suction. These cells are used for chromosome analysis or testing of other specific conditions.

The risk for complications that may lead to a miscarriage is less than 1 in 100, and each center will typically quote their individual procedure risk.8 ACOG has reported that this rate of pregnancy loss as a result of chorionic villus sampling complications is higher than that of amniocentesis because of the background risk of pregnancy loss early in the pregnancy.7 Noninvasive prenatal diagnosis is an emerging technology that obtains and analyzes fetal DNA from maternal blood. This fetal genetic material can be obtained without amniocentesis or

Conclusion Only recently has the purpose of prenatal care included the health and development of the fetus. Problems that occurred during or after pregnancy were historically credited to the mother or to chance, without much consideration given to fetal development. Recent advancements in perinatal medicine and the application of these advancements have shed light on the many complicated aspects of fetal development. ■

References 1. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 77: screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007; 109:217-227.

2. Breathnach FM, Fleming A, Malone FD. The second trimester genetic sonogram. Am J Med Genet C Semin Med Genet. 2007;145C:62-72.

3. Goetzl L. Adverse pregnancy outcomes after abnormal first-trimester screening for aneuploidy. Clin Lab Med. 2010;30:613-628.

4. Cameron M, Moran P. Prenatal screening and diagnosis of neural tube defects. Prenat Diagn. 2009;29:402-411.

5. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 101: ultrasonography in pregnancy. Obstet Gynecol. 2009;113:451-461.

6. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 88: invasive prenatal testing for aneuploidy. Obstet Gynecol. 2007;110: 1459-1467.

7. Tabor A, Alfirevic Z. Update on procedure-related risks for prenatal diagnosis techniques. Fetal Diagn Ther.

2010;27:1-7. Epub 2009 Dec 24.

8. Kavanagh DM, Kersaudy-Kerhoas M, Dhariwal RS, Desmulliez MP. Current and emerging techniques of fetal cell separation from maternal blood. J Chromatogr B Analyt Technol Biomed Life Sci. 2010;878:1905-1911.

Epub 2010 May 27.

9. Chauhan SP, Scardo JA, Hayes E, et al. Twins: prevalence, problems, and preterm births. Am J Obstet Gynecol.

2010;203:305-315.

See Commentary on page 22

February 2011 l VOLUME 3, NUMBER 1

21

CONTINUING EDUCATION

WWW.INFERTILITYREPRONEWS.COM

COMMENTARY

The Reasons for Prenatal Screening

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

P

renatal diagnosis is an area in medicine that has resulted in some changes in prenatal genetic screening guidelines. Approximately 2000 babies are born in the United States each year with Down syndrome (or trisomy 21), a genetic disorder caused by an extra chromosome.1 It is well known that the risk for a chromosomal abnormality in a newborn increases with the mother’s age.

Until recently, genetic testing has been reserved only for women considered to be at high risk—those aged >35 years, those with a history of previous autosomal or sex chromosome aneuploidy, those with ≥3 previous miscarriages, parental carriers, or those with a defect already diagnosed by ultrasound.1 New testing options have led to changes in genetic screening guidelines, and now early screening should be offered to all women of any age.

Age Considerations At age 35 years, the risk for a pregnant woman is 1 in 92 for having a child with any chromosomal disorder and 1 in 378 for a child with Down syndrome.1,2 At age 25 years, the woman’s risk is 1 in 476 for having a child with any chromosomal disorder and 1 in 1250 for having a child with Down syndrome. By contrast, a 45-year-old woman’s risks are 1 in 21 and 1 in 30, respectively, for any chromosomal disorder or for Down syndrome.1 Of note, although the risk is higher in older women, most (80%) babies with Down syndrome are born to younger women.2,3 The reason for this may be that younger mothers may not be offered screening tests, or they may feel that they are relatively risk free until age 35 years. According to the American College of Obstetricians and Gynecologists (ACOG), providers are “obligated to fully inform our patients of their healthcare options, including prenatal testing. It is entirely up to the patient to decide whether or not she wishes to be screened for fetal chromosomal abnormalities, without judgment” from the provider.2 Noninvasive options are considered to be reassuring to the mothers and have no risk to the fetus or to the pregnancy. Diagnosis of chromosomal abnormalities currently requires invasive testing, which does involve risk to the pregnancy, with about a 1% risk of miscarriage.2

22

First-Trimester Screening First-trimester combined screening is an early, effective, and noninvasive genetic screening test for the general population, with high detection rates and low false-positive rates. Since 2007, ACOG has recommended that firsttrimester screening should be offered to all pregnant women in the late-first and early-second trimesters of pregnancy; these screenings consist of an ultrasound to measure nuchal translucency with the associated serum screening, pregnancyassociated plasma protein A (PAPP-A), and beta-human chorionic gonadotropin (hCG).3

of uniformity in the definition of abnormal findings.7 The identification of 2 separate soft ultrasound markers, with or without abnormal serum screening, should be referred to high-risk specialized centers for additional genetic counseling and possible testing.7 When to Consider Invasive Testing If every pregnant woman is to be offered first-trimester screening, who should be considered for invasive genetic testing and the associated risks of the procedure? As a provider working with pregnant women, I ask my patients the

Approximately 2000 babies are born in the United States each year with Down syndrome (or trisomy 21), a genetic disorder caused by an extra chromosome. It is well known that the risk for a chromosomal abnormality in a newborn increases with the mother’s age.

First-trimester screening is currently offered or is a standard of care for all pregnant women in more than 45 countries, including Israel, Australia, New Zealand, and many European countries.4,5 Recent evidence suggests some benefit in the ultrasound measurement and correlation of nasal bone determination, ductus venosus flow, and nuchal translucency, along with fetal heart rate.5,6 Second-Trimester Screening Second-trimester screening consists of noninvasive testing, which includes maternal serum screening and detailed anatomical ultrasound survey. Maternal serum markers, available between 15 and 21 weeks of gestation, include evaluation and correlation of alpha-fetoprotein, hCG, unconjugated estriol, and dimeric inhibin A levels to evaluate the risk (increased or decreased) for Down syndrome, trisomy 18, and open spina bifida.7 Studies are currently looking at fetal DNA isolated from maternal blood for chromosomal analysis, which looks promising as a noninvasive diagnosis option.

A detailed ultrasound at 20 to 22 weeks of gestation is utilized to assist with the diagnosis of aneuploidy. Identification of “soft” ultrasound markers, such as nuchal fold thickness, shortened femur to humerus, pyelectasis, and hyperechogenic bowel, can be helpful but also contradictory, because of a lack

February 2011 l VOLUME 3, NUMBER 1

following important questions when helping them to choose the type of testing that is best for their needs: 1. What type of information would you like to know?

2. Would this information change the course of your pregnancy?

3. Ultimately, if you had correct genetic information, would you terminate the pregnancy because of a positive or abnormal test result?

4. Will you worry excessively if you don’t have answers?

If the patient answers yes to any of these questions, then she should proceed to definitive (ie, invasive) testing, chorionic villi sampling, or amniocentesis to get chromosomal analysis.

Clinical Applications A common question is, “Why should parents consider any prenatal genetic screening if abortion is not an option?” If a genetic condition is detected, then additional fetal testing may be used to serially evaluate the baby’s growth and late-pregnancy reassurance of fetal health by fetal non–stress testing (ie, that which consists of using an electronic fetal heart monitor to record fetal heart beat and reaction to fetal movement) and biophysical profile (using a special ultrasound to look at fetal movements, tone, breathing, and fluid level).

These tests would not typically be ordered for a chromosomally normal

fetus. The baby with Down syndrome may have cardiac anomalies or physical defects that should be addressed at birth in the setting of a high-risk maternity hospital.7 Feeding difficulties and developmental delays are also common in trisomies and require early intervention by specialists, which can be prearranged when this information is available.

Finally, certain hospitals that specialize in research may provide fetal surgery (eg, spina bifida repair), or treatment may be a possibility in some cases. Early diagnosis allows parents time to accept and adjust to the loss of the option for a “perfect child.” Locating support groups and planning for lifestyle changes can also be important coping mechanisms.

Conclusions Because the purpose of prenatal genetic screening is to diagnose congenital conditions, physical defects, and abnormalities in the fetus before birth, all pregnant women should be offered firsttrimester screening as an effective early screening option. However, patients also have choices for traditional secondtrimester testing, invasive testing, or no testing at all.

Nurses managing pregnant women should be unbiased when reviewing testing options and allow the patient to make her own decision based on her needs. There are many reasons to consider invasive testing other than termination of pregnancy. Early diagnosis of genetic abnormalities offers better management and follow-up options for the mother and the baby.

References 1. Centers for Disease Control and Prevention. Chorionic villus sampling and amniocentesis: recommendations for prenatal counseling. MMWR Recomm Rep. 1995;44:1-12.

2. American College of Obstetricians and Gynecologists.

ACOG screening guidelines on chromosomal abnormalities, what they mean to patients and physicians. News release. May 7, 2007. www.acog.org/from_home/publications/ press_releases/nr05-07-07-1.cfm. Accessed January 24, 2011.

3. ACOG Committee on Practice Bulletins. ACOG Practice Bulletin No. 77: Screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007;109:217-227.

4. Boyd P, Garne E, eds, for EUROCAT. Special Report: Prenatal Screening Policies in Europe. 2010. www.euro cat-network.eu/content/Special-Report-PrenatalScreening-Policies.pdf. Accessed January 27, 2011.

5. Government of Western Australia Department of Health, Office of Population Health Genomics.

Department of Health Policy Recommendations 2010-2015, Model of Best Practice for Prenatal Screening Choices. 2010. www.genomics.health.wa.gov.au/publications/docs/DOHpolicy-recommendatinos-2010-15.pdf. Accessed January 27, 2011.

6. Wee LK, Arooj A, Supriyanto E. Computerized automatic nasal bone detection based on ultrasound fetal images using cross correlation techniques. WSEAS Trans Information Sci Applications. 2010;7:1068-1077.

7. American College of Obstetricians and Gynecologists. 2007 Compendium of Selected Publications. Vol II, Practice Bulletins. Prenatal Diagnosis of Fetal Chromosomal Abnormalities. Washington, DC:ACOG; 2007; 27:597-607.

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Men’s Health

Understanding Benign Prostate Hyperplasia: A Common Condition in Older Men Assessing Current Treatment Options

By Neil Canavan

T

here are currently 37 million men aged ≥50 years in the United States, and an estimated 50% of them have histologic benign prostate hyperplasia (BPH). A detailed understanding of the condition—the diagnosis, progression, and treatment options—will be critical to effectively manage a rapidly expanding patient population.

Key to this understanding is that BPH is progressive. “By age 70, 80% to 90% of all men will have developed BPH,” said Bhalchandra Parulkar, MD, Associate Professor of Urology, University of Massachusetts Medical School, Worcester.

This does not mean these men have an enlarged prostate, or a noticeable urinary obstruction. “If you take a needle biopsy and look at the pathology slide you will see ‘BPH’—the term is used as a synonym for having an enlarged prostate, but that’s not really true. BPH is a histological diagnosis,” Dr Parulkar said.

Those who have histologic BPH do not always have an enlarged prostate; this is an important distinction when considering potential treatment options.

When doing a digital rectal examination (DRE), the physician or nurse is feeling the outside of the prostate; however, the symptoms of BPH are produced from within.

“For some individuals, the capsule enclosing the prostate is tight. When the prostate starts growing, the capsule prevents it from expanding, and therefore, it grows inwards,” he said.

This produces the same symptoms of an enlarged prostate, but without the physical size. In general, this discussion is framed by the consideration of an enlarged prostate, defined as a prostate of ≥30 mL in volume.

At ≥30 mL, prostate size slowly starts making greater demands on the bladder, eventually resulting in muscle hypertrophy. The muscles then contract more frequently, which causes the combined problem of weak urine stream, because of a blocked urethra, and irritative symptoms such as frequency, urgency, and urge incontinence. “Hesitancy is a classic and common symptom of enlarged prostate; however, storage symptoms are the most bothersome,” said Dr Parulkar.

Most men do not mind taking some extra time to establish a urine stream, but frequency, urgency, or nocturia can have a significant impact on quality of life.

24

Putting Your Finger on the Problem “If the diagnosis of BPH was simple, every primary care doctor would treat it. But there are many other conditions that mimic prostate symptoms,” Dr Parulkar noted. These include prostate or bladder cancer, prostatitis, urinary tract infections, renal dysfunction, diabetes, urethral narrowing, and interstitial cystitis. All these possibilities must be ruled out before making a BPH diagnosis.

severity of the given complaint; scores range from mild to severe.

Drug Treatment Options Saw palmetto. Sometimes combined with zinc and selenium, if a patient has mild symptoms but prefers not to use prescription medication, this is an option. Some patients experience symptom relief, however, randomized studies indicate no benefit beyond the placebo effect.

“Hesitancy is a classic and common symptom of enlarged prostate; however, storage symptoms are the most bothersome.”

—Bhalchandra Parulkar, MD

When a man presents with potential BPH symptoms, you must first consider the risks. “On a patient’s first visit I consider these factors for BPH progression—age over 50, prostate exceeding 30 mL in volume, PSA [prostate-specific antigen] ≥1.4 ng/mL, an AUA-SI [American Urological Association Symptom Index] score over 7, and weak urinary flow.”

Diagnostic work-up includes a DRE and laboratory tests for creatinine, urinalysis for infection, and PSA. Further tests may include a urine flow study, postvoid residue via ultrasound, and, if needed, urodynamics and cystoscopy. A voiding diary may be requested to establish functional bladder capacity, as well to inform in cases where the chief complaint is nocturia. Finally, the patient is asked to complete the international prostate symptom score to establish the

Dutasteride/finasteride. The rationale for the use of these agents is to prevent the conversion of testosterone to dihydrotestosterone (DHT), which is required for prostate growth. “These drugs decrease DHT but do not eliminate testosterone, so men don’t experience too many significant adverse reactions,” said Dr Parulkar, “and the earlier you prescribe them, the better they will work.” These agents will shrink the prostate, but as mentioned in the context of symptoms without enlargement, this treatment will be ineffective. There is a further downside: “These drugs take up to 6 months to work. That can be a hard sell to the uncomfortable patient,” Dr Parulkar pointed out. There is also this caveat: If your patient is taking these drugs, future PSA values must be doubled.

Alpha blockers. Alpha receptors are

Case Study A relatively young man (age 55 years) presents with a mild urologic complaint, but a 30-g size prostate.

“You can bet that with time, that prostate is going to grow and cause more problems,” said Dr Parulkar.

This is particularly true if the patient has an older close relative with BPH. A good urologic physician or nurse would anticipate worsening symptoms and suggest preventive treatment.

What if you chose a less-aggressive approach? Remember, BPH is progressive. Data indicate that men aged >60 years with enlarged prostates and

February 2011 l VOLUME 3, NUMBER 1

obstructive urinary symptoms have a 39% lifetime risk of requiring surgery.

Furthermore, left untreated, 1 of 6 patients with an enlarged prostate, urologic symptoms, and a PSA ≥1.4 ng/mL have acute urinary retention, or BPH-related surgery within 4 years of diagnosis. “You must get a baseline PSA,” advised Dr Parulkar. “It’s a good predictor of BPH progression.”

The higher the PSA, the faster the growth. And keep a sharp eye on the patient; once a prostate progresses beyond 60 g, most of the simple treatments are off the table.

present on the prostate and related blood vessels; receptor antagonism results in loss of local muscle tone. “If tone is lost, the urethra expands, the bladder neck expands and this creates a wider passage for the urine to flow.

Alpha blockers do not reduce the prostate size, but effectively achieve symptom relief, “and that’s what the patient came to you for,” said Dr Parulkar, adding that patients are encouraged by the rapid onset of action for this drug class and their relative inexpensive cost. However, as the prostate continues to grow, symptoms will eventually worsen. A combination with dutasteride or finasteride is often recommended for initial treatment.

Surgical Options Stents. Typically used in nursing homes, stents are not for use in younger patients.

Needle ablation radiofrequency.

Very precise technique using an endoscope through the urethra, this technique applies heat to the prostate, thereby destroying and collapsing target tissue. Patients go home the same day with a catheter.

Alpha receptors are present on the prostate and related blood vessels; receptor antagonism results in loss of local muscle tone.

Microwave therapy. This technique is similar to radiofrequency in that it heats the tissue. This method is rapid, and catheters are generally not required.

Laser vaporization. This technique is also rapid, but it is not widely available.

Transurethral resection of the prostate (TURP). This is the most invasive approach with the greatest chance of complications, short of open prostatectomy. TURP requires hospitalization using a general or spinal anesthetic. Recovery time, during which strenuous activity must be avoided, lasts up to 6 weeks.

“Keep in mind that with all these methods, the potential for prostate cancer still exists. The tissue you’re targeting is internal, oncogenesis occurs at the periphery,” Dr Parulkar cautions. Patients will require continued follow-up. ■

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CLINIC PRO FILE

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eart disease is not just a diseas e of older wome n; in fact, even care nurse practitioner and cofounder of pregnancy can Heartstrong, LLC place younger (www.heart-stron women at risk com). for g. tions. This 3-part heart-related condi- Latrel With her colleague Margi la, she has coauth e series will help nurses in the recogn guide includ ing Take Charg ored 3 books, ition and mana ment of the numb e: er 1 killer of Amer ge- Guide to a Healthier Heart A Woman’s women—heart ican (2008). diseas CLINIC PRO This information e.

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The official pu Academy of O blications of the American B/GYN and In fertility Nurses

Nutrition

Magnesium Significantly Lowers Sudden Cardiac Death Risk in Women

By Jessica A. Smith

H

eart disease is often considered a men’s illness, but the disease is the leading cause of death in women. And although cardiovascular (CV) health discussions often focus on heart attack, an equal risk is posed by sudden cardiac death. It therefore is appropriate for women’s healthcare providers to do what they can to help

patients to mitigate their CV risks as much as possible.

A new study has shown that women can help to decrease their risk for sudden cardiac death by increasing their magnesium intake (Chiuve S, et al.

Plasma and dietary magnesium and risk of sudden cardiac death in women. Am J Clin Nutr. 2011;93:253-260). The

Table Selected Food Sources of Magnesium

researchers analyzed data from the Nurses’ Health Study, examining the association between magnesium intake and sudden cardiac death in 88,375 healthy women.

Information on magnesium intake and other nutrients, as well as lifestyle issues and overall health was collected over 26 years of follow-up. A total of 505 cases of sudden cardiac death or arrhythmic death were documented during the follow-up period. For plasma magnesium, the researchers conducted a nested case-control analysis that included 99 cases of sudden cardiac death and 291 controls matched for age, ethnicity, smoking, and presence of CV disease.

Results showed that the relative risk for sudden cardiac death was significantly lower in women within the highest quartile compared with those in the lowest quartile of dietary and plasma magnesium. Plasma magnesium showed the stronger relationship with sudden cardiac death risk, with each 0.25-mg/dL incremental increase in plasma magnesium associated with a 41% decreased risk for sudden cardiac death.

Counseling patients on the importance of consuming enough magnesium and on what food sources provide the crucial mineral (Table) can help them to maintain CV health. ■

Milligrams

Proportion of daily requirement, %

Halibut, cooked, 3 oz

90

20

Almonds, dry roasted, 1 oz

80

20

Cashews, dry roasted, 1 oz

75

20

Soybeans, mature, cooked, ½ c

75

20

Recipes for Healthy Living

Spinach, frozen, cooked, ½ c

75

20

Curry Quinoa

Nuts, mixed, dry roasted, 1 oz

65

15

Courtesy of Ariadne R. Buffery

Cereal, shredded wheat, 2 rectangular biscuits

55

15

Oatmeal, instant, fortified, prepared with water, 1 c

55

15

Potato, baked w/ skin, 1 medium

50

15

Peanuts, dry roasted, 1 oz

50

15

Peanut butter, smooth, 2 tbs

50

15

Wheat bran, crude, 2 tbs

45

10

Black-eyed peas, cooked, ½ c

45

10

Yogurt, plain, skim milk, 8 fluid oz

45

10

Bran flakes, ½ c

40

10

Vegetarian baked beans, ½ c

40

10

Rice, brown, long-grain, cooked, ½ c

40

10

Lentils, mature seeds, cooked, ½ c

35

8

Avocado, California, ½ c pureed

35

8

Kidney beans, canned, ½ c

35

8

Pinto beans, cooked, ½ c

35

8

Wheat germ, crude, 2 tbs

35

8

Chocolate milk, 1 c

33

8

Banana, raw, 1 medium

30

8

Milk chocolate candy bar, 1.5-oz bar

28

8

Milk, reduced fat (2%) or fat-free, 1 c

27

8

Bread, whole wheat, commercially prepared, 1 slice

25

6

Raisins, seedless, ½ c packed

25

6

Whole milk, 1 c

24

6

Chocolate pudding, 4-oz ready-to-eat portion

24

6

Food

February 2011 l VOLUME 3, NUMBER 1

Directions: 1. Dice and sauté onion and carrot in olive oil, using the pot in which you will be cooking the quinoa 2. Rinse the quinoa, according to preparation/cooking instructions on package 3. Add water and quinoa to pot (mix with the onion and carrot) 4. Add chopped garlic, whole raisins, and curry powder 5. Bring to a boil, then reduce the heat to simmer for 10-15 minutes, or until the quinoa has absorbed all the liquid.

Health Benefits of Quinoa Although not widely known, quinoa (KEEN wah), a seed originating from South America, packs an abundance of nutrients. High in protein, calcium, and iron, quinoa also contains all 8 essential amino acids necessary for human tissue development. It surpasses regular cereal grains in protein, healthy fats, fiber, phosphorus, and calcium, and is high in lysine, cystine, and methionineamino acids, which are low in most other grains.

Great for pregnant women and vegetarians, quinoa is 12% to 18% protein—about ½ cup fulfills a child’s daily protein requirement. It also contains albumen, a protein found in egg whites, blood serum, and various plant and animal tissues.

Quinoa is also great for persons with gluten sensitivity, because it is gluten-free.

The manganese and copper in quinoa team up to work as an antioxidant, helping the body to combat cancer-causing free radicals.

Send Us Your Healthy Recipes

Source: National Institutes of Health Office of Dietary Supplements. Dietary supplement fact sheet: magnesium. http://ods.od.nih.gov/factsheets/magnesium/.

Accessed February 1, 2011.

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What you will need: 1 tbs olive oil 1⁄2 full-size carrot 1 small onion 2 cups water 1 cup quinoa (rinsed) 1-2 cloves garlic 1⁄4 cup golden raisins Curry powder (to taste, but likely more than you think)

If you have a recipe that is especially beneficial to women’s health, pregnant women, lactating mothers, or newborns, please send it to lara@novellushc.com.

Include a brief explanation of the health benefits of the recipe and any other tips you wish to share with your colleagues, as well as your name, and e-mail or phone number.

To submit online, go to www.infertilityrepronews.com/submit-recipe and upload the file.

Clinical News FDA Requests More...

Continued from page 10

mendation from an FDA advisory committee for the combination drug naltrexone HCl/bupropion HCl (Contrave), which is designed to address biological and behavioral obstacles to weight loss, signaled some renewed hope for weightloss products.

After pulling sibutramine (Meridia) from the market last year because of increased risks for heart attack and stroke, the FDA then cited tumor risks for another investigational weight-loss drug, tesofensine (Qnexa), requiring the makers to provide additional data on the drugâ&#x20AC;&#x2122;s potential for causing birth defects and cardiovascular problems.

Now, despite the advisory committeeâ&#x20AC;&#x2122;s recommendation, on January 31, 2011, the FDA requested the drug maker of Contrave to conduct additional clinical randomized trials to provide more data on the potential for major cardiovascular risk factors that have been associated with several weight-loss drugs. This decision reinforces the FDAâ&#x20AC;&#x2122;s extreme caution with regard to the approval of new weight-loss agents.

Induced, Early-Term Abortion Does Not Increase Mental Disorders The use of psychiatric services is no greater after a first-trimester induced abortion compared with before the event, Danish researchers have found (Munk-Olsen T, et al. N Engl J Med. 2011;364:332-339).

Using Danish national registers of hospital admissions and admissions to psychiatric inpatient facilities, the researchers compared rates of psychiatric contacts in the 9 months before a firsttime, first-trimester induced abortion or first childbirth with rates in the 12 months after the event. The sample included 84,620 first-time, first-trimester abortions and 280,930 live births.

The rates of a first psychiatric contact were not significantly different in the 9 months before and the 12 months after abortion (14.6 vs 15.2 per 1000 personyears). Among the women who gave birth, the risk for a psychiatric contact was significantly greater after childbirth (6.7 per 1000 person-years) than before childbirth (3.9 per 1000 person-years).

These data suggest that girls and women who undergo an abortion have more psychiatric contact than those who deliver a child, â&#x20AC;&#x153;but this relationship was evident before the abortion or childbirth occurred,â&#x20AC;? according to the authors. â&#x20AC;&#x153;This suggests that any propensity toward mental health disorders in girls or women who have induced abortions predates the abortion and indeed may make the termination of the pregnancy more likely,â&#x20AC;? the authors suggested.

Annual Ovarian Cancer Screening Reduces Mortality Slightly Screening women annually for ovarian cancer yields a limited reduction in mortality, according to new data (Havrilesky LJ, et al. Cancer. 2011;117: 545-553).

In this study, the researchers used a computer-simulated model of ovarian cancer natural history (the 1-phenotype

model) to take into account aggressive and indolent phenotypes (the 2-phenotype model) along with data from the Surveillance, Epidemiology, and End Results Program of the US National Cancer Institute and the United Kingdom Collaborative Trial of Ovarian Cancer Screening to reach their conclusions.

Results showed that an annual population-based screening strategy for postmenopausal women (aged 50-85 years)

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Mortality reductions gleaned from annual screening in postmenopausal women were 14.7% and 10.9%, respectively, for the 1-phenotype and 2-phenotype models. The researchers attributed the lesser reduction in mortality from the 2-phenotype model to the higher frequency of indolent cancer diagnoses at early stages. â&#x2013;

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February 2011 l VOLUME 3, NUMBER 1

27

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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