Moving Forward With Research Involving Pregnant Women: A Critical Role for Wisdom From the Field

Abstract

Each year, hundreds of thousands of women in the United States confront significant medical illness while pregnant: Hypertension, diabetes, serious psychiatric illnesses, autoimmune diseases such as arthritis and lupus, and even cancers complicate pregnancies. Yet we face a critical dearth of information about how to treat them. Little is known about how drugs work in their bodies, whether those drugs are safe for the fetus, and the extent to which treatment or nontreatment affects maternal and child health (Chambers, Polifka, and Friedman 2008; Fisk and Atun 2008). Recently, a groundswell of attention has begun to highlight the urgent need to garner adequate evidence for the treatment of pregnant women who face illness (Lyerly, Little, and Faden 2008, 2009; Baylis 2010; Macklin 2010). The National Institutes of Health Office of Research on Women’s Health convened a research forum on enrolling pregnant women in research on October 18, 2010 that emphasized both the imperative for and early work on such research1; the Obstetric-Fetal Pharmacology Research Unit (OPRU) Networkand the Microbicide Trials Network have begun to pioneer innovative models for research involving pregnant women.2 The Second Wave Initiative—so named because it calls for a