The Second Wave - Toward the Responsible Inclusion of Pregnant Women in Medical Research

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Workshop at Georgetown University

Each year, hundreds of thousands of pregnant women in the US face significant medical illness during their pregnancies. Diabetes and hypertension complicate 40,000+ pregnancies; psychiatric illness complicates an estimated 500,000; cancer and autoimmune diseases are not uncommon, and yet we have surprisingly little data about how to safely and effectively treat these conditions. The pregnant body can substantially change the ways in which drugs are metabolized; and concerns about the safety of taking medication must be balanced against the medical risks — to woman and fetus alike — of undertreating significant medical disease.

In April of 2009, scholars from Georgetown, Johns Hopkins, and Duke held a two-day workshop to make progress in this challenging area. Participation included leaders from the NIH, FDA, as well as from leading academic medical centers. Supported by a Reflective Engagement grant from Georgetown, the outcome of the workshop identified barriers, articulated the costs of ignorance, and proposed consensus proposals that can immediately begin to make a difference in pregnant women's health. Second Wave advocates have also worked over the summer with Members of Congress and their staffs to raise awareness of the issue. Those efforts resulted in inclusion of language in the House Committee Report accompanying the Fiscal 2010 Appropriations for the Departments of Labor, Health and Human Services and Education.


Margaret Little, Ph.D., Kennedy Institute of Ethics, Georgetown University
Ruth Faden, Ph.D., M.P.H., is Berman Institute of Bioethics, Johns Hopkins University
Anne Drapkin Lyerly, M.D., M.A., Trent Center for Bioethics, Duke University
Jason Umans, M.D., Ph.D., F.A.C.P., Georgetown University Hospital


Please email Kelly Heuer, program assistant.


Attendance at the workshop was by invitation only.


Last updated on October 6, 2009