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November 27, 2018

Increasing the Participation of Pregnant Women in Clinical Trials

Author Affiliations
  • 1National Institutes of Health, Bethesda, Maryland
  • 2now with Department of Obstetrics and Gynecology, University of Rochester, Rochester, New York
  • 3now with Division of Medical Genetics, Stanford University, Stanford, California
JAMA. 2018;320(20):2077-2078. doi:10.1001/jama.2018.17716

Preventing pregnant women from participating in clinical trials is well intentioned but misguided. Pregnant women are a “vulnerable” population in research due to their relationship with the fetus who cannot consent to participation.1 For ethical committee approval, study interventions in pregnancy must directly benefit or pose minimal risk to the mother and fetus, and often consent must be obtained from both parents. As a result, institutional review boards and investigators frequently limit the inclusion of pregnant women in trials even when they may benefit from study interventions. Thus, more than 80% of pregnant patients are routinely prescribed therapies that have not been studied in pregnancy.2 Given the limited amount of safety data, it is largely unknown if medications could harm patients, which interventions are truly effective, or whether it is safe to delay treatment until after pregnancy.

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