NATIONAL INSTITUTES OF HEALTH, OFFICE OF THE DIRECTOR

Pregnant Women in Clinical Studies. -- While over the last two decades, women have increasingly been included in clinical studies, pregnant women continue to be largely excluded from medical research, leading to a troubling lack of knowledge about how to treat pregnant women's illnesses and limited understanding of how illness in pregnancy affects women's health over time. Many pregnant women suffer from serious medical conditions including diabetes, hypertension, depression, autoimmune disorders, and cancer. Pregnancy significantly changes women's physiology, including blood flow, digestion, kidney function and hormonal and enzymatic activity, in ways that can dramatically change the nature and progression of disease and the way that medications work. Despite these important differences, pregnant women are rarely involved in health research and, as a result, in many cases little is known about how to safely and effectively manage illness in pregnancy. The Committee encourages NIH to expand research on pregnant women with the goals of better understanding the long-term health effects on women of disease states in pregnancy, the proper therapeutics for pharmacologic treatments for pregnant women who face illness, and the safety and efficacy of medications administered to pregnant women and fetuses.