Research in Pregnant Subjects: Increasingly Important, but Challenging.

Joseph R Biggio

doi:10.31486/toj.19.0077

Abstract

Background: The number of pregnant women with medical comorbidities continues to increase. A large proportion of pregnant women are exposed to medications during pregnancy, but only a fraction of the medications used have been investigated during pregnancy with regard to benefits, risks, and doses.Methods: This article includes a review of potential deterrents and barriers to pregnant women enrolling in clinical research studies and the federal regulations governing enrollment of pregnant women in research.Results: Research in pregnant women has been hampered by concerns for liability, the complex physiology of pregnancy with changes related to stage of pregnancy, and federal regulations that deemed pregnant women a vulnerable population. While recent revisions to federal regulations have removed pregnant women from the classification of vulnerable population, regulations regarding consent requirements still limit women's ability to decide on participation in clinical trials. The Department of Health and Human Services established the Task Force on Research Specific to Pregnant Women and Lactating Women to help identify and reduce these barriers.Conclusion: While recognition of the need for more scientific knowledge on the effects of medications and other interventions in pregnancy is widespread, a number of barriers that hinder enrollment of pregnant women in clinical trials remain.

Highlights

BackgroundThe number of pregnant women with medical comorbidities continues to increase
In the United States each year, more than 6 million pregnancies and approximately 4 million births occur.[1]
Up to 90% of women are estimated to be exposed to at least one medication during pregnancy, and at least 60% of women who give birth take one or more medications to treat a chronic medical condition or a condition that arises during the pregnancy.[2,3]

Summary

Background

The number of pregnant women with medical comorbidities continues to increase. Methods: This article includes a review of potential deterrents and barriers to pregnant women enrolling in clinical research studies and the federal regulations governing enrollment of pregnant women in research. Results: Research in pregnant women has been hampered by concerns for liability, the complex physiology of pregnancy with changes related to stage of pregnancy, and federal regulations that deemed pregnant women a vulnerable population. While recent revisions to federal regulations have removed pregnant women from the classification of vulnerable population, regulations regarding consent requirements still limit women’s ability to decide on participation in clinical trials. Conclusion: While recognition of the need for more scientific knowledge on the effects of medications and other interventions in pregnancy is widespread, a number of barriers that hinder enrollment of pregnant women in clinical trials remain

INTRODUCTION

Findings

CONCLUSION