Each year, hundreds of thousands of pregnant women in the US face significant medical illness during their pregnancies, and many more do so worldwide. Diabetes and hypertension complicate 40,000+ pregnancies; psychiatric illness complicates an estimated 500,000; cancer and autoimmune diseases are not uncommon. Yet we have surprisingly little data about how to safely and effectively treat these conditions. The costs of ignorance are significant: the pregnant body can substantially change the ways in which drugs are metabolized; concerns about the safety of taking medication must be balanced against the medical risks — to woman and fetus alike — of undertreating significant medical disease. Without information to guide these decisions, pregnant women and the children they bear face risks of under-treatment, ineffective treatment, and short-and long term health consequences.

Co-Principal Investigators

Current Projects

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PHASES: Pregnancy & HIV/AIDS: Seeking Equitable Study

  • Principal Investigator: Anne Lyerly
  • The multi-year project funded by the U.S. National Institutes of Health seeks ethical solutions to advance research at the intersection of women’s reproduction and HIV prevention, treatment, and management.
  • hivpregnancyethics.org

Zika and Beyond: Pregnancy, Research, and Public Health Emergencies

  • Co-principal investigators: Anne Lyerly and Ruth Faden
  • The multi-year project funded by the United Kingdom’s Wellcome Trust seeks ethical solutions to ensure that the health needs of pregnant women and their offspring are appropriately included in research efforts addressing emerging public health crises
  • zika.pregnancyethics.org

History of the Second Wave Initiative

Nearly a decade ago, Anne Lyerly partnered with Ruth Faden (Johns Hopkins Berman Institute of Bioethics) and Maggie Little (Georgetown Kennedy Institute for Ethics) to move forward responsible inclusion of pregnant women in research. The Second Wave Initiative, launched in 2009, is a collaborative academic effort to identify, develop and advance ethically and scientifically responsible solutions for increasing our knowledge base for the treatment of pregnant women who face medical illness. The initiative took shape in April of 2009, when 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 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. Their research and scholarship in the area are ongoing, with empirical studies aimed at understanding what matters to pregnant women considering enrollment in studies, conceptual work to help guide responsible research with pregnant women in the future, and two large projects to develop concrete guidance for ethically responsible inclusion of pregnant women in pressing health contexts, including HIV, Zika, as well as other public health emergencies.

Project Twitter: @pregnancyethics

Second Wave Initiative Project Website: secondwaveinitiative.org

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