Women's Views About Participating in Research While Pregnant

Anne Drapkin Lyerly, MD, MA; Emily E. Namey, MA; Beverly Gray, MD; Geeta Swamy, MD; Ruth R. Faden, PhD, MPH

Disclosures

IRB. 2012;34(4):1-8. 

In This Article

Abstact and Introduction

Introduction

One of the great challenges in obstetrics is knowing how best to prevent or treat illness during pregnancy. This stems in large part from longstanding reluctance to conduct research with pregnant women. Due to ethical complexities and concerns about research risks, pregnant women and their interests have been underrepresented in research. A consequence has been a dearth of information about the safety and appropriate dosing of medications and vaccines during pregnancy and a limited understanding of how illness during pregnancy affects women's health over time.[1]

Broad-based exclusion of pregnant women from biomedical research studies endangers both women and children. More than 400,000 women each year face serious medical illness during pregnancy, yet there are inadequate data to guide treatment decisions. Differences in the pharmacokinetics and pharmacodynamics of drugs during pregnancy mean that standard doses may not safely or effectively meet pregnant women's medical needs. Moreover, unknown effects of drugs on fetuses mean that physicians must guess about which approach is safest, and in the absence of reassuring data on safety and efficacy, women and physicians often discontinue or eschew medication even when harms of untreated disease may outweigh a medication's risks.[2] In clinical settings, new drugs and vaccines are often used in pregnant women with neither adequate evidence nor the protections of research oversight, leading some to characterize clinical care during pregnancy as "postmarketing experimentation."[3]

The drawbacks of the current approach to risk and research with pregnant women were brought into sharp relief by the recent H1N1 influenza pandemic, which was marked by excess morbidity and mortality in pregnant women.[4] While the disproportionate impact on pregnant women was attributed in part to physiologic vulnerability, such as decreased lung capacity, other factors were likely to have contributed, such as delays in treatment with antiviral medications, whose safety and efficacy during pregnancy were unknown.[5] Given dismal vaccination rates against seasonal influenza in past years and a growing concern about the impact of H1N1 on pregnant women, public health officials and others urged pregnant women and physicians to use the H1N1 vaccine.

In a groundbreaking effort to learn about the safety and immunogenicity of an H1N1 inactivated influenza vaccine administered to pregnant women, the National Institutes of Health (through the National Institute of Allergy and Infectious Diseases) conducted two phase II, multicenter randomized vaccine trials involving pregnant women.[6] Trial participants were randomized to receive one of two different dosages of the H1N1 vaccine, which differed in significant respects from previous seasonal flu vaccines in that it was directed against a strain of influenza that had previously not been seen in humans and had not been targeted in vaccines in past years. The two H1N1 vaccine studies were among the first studies of vaccines with such limited clinical experience during pregnancy,[7] involved 176 pregnant women, and, according to preliminary reports, revealed that the usual adult dose could be safely and effectively administered after the first trimester of pregnancy.[8]

In addition to the important clinical findings, the H1N1 vaccine trials with pregnant women presented a rare opportunity to understand women's reasons for participating in research pertaining to nonobstetrical illness during pregnancy. While awareness of the public health and clinical need for advancing such research has surged,[9] those working to improve the evidence base for treating pregnant women will need to understand what matters most to the pregnant women who consider enrolling in needed clinical trials. Yet data regarding women's views about participating in research while pregnant are limited,[10] and to our knowledge, no studies have assessed factors relevant to participating in drug or vaccine trials from the perspective of pregnant women. For the study described here, we conducted in-depth interviews with women who participated in the H1N1 vaccine trials to obtain their views about participating in research while pregnant.

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