Fewer than 1% of U.S. clinical drug trials enroll pregnant participants, study finds

A new study by researchers from the Brown University School of Public Health found that pregnant women are regularly excluded from clinical drug trials that test for safety, raising concerns for the efficacy of these medications for maternal and child health.

The study, published in the American Journal of Obstetrics and Gynecology, analyzed 90,860 drug trials involving women ages 18 to 45 from the past 15 years and found that only 0.8% included pregnant participants. About 75% of the studies excluded them, potentially leaving critical safety and efficacy questions unanswered.

“When pregnant women are excluded from drug trials, it is harder to know if the medication is safe for mothers and their children,” said Alyssa Bilinski, an assistant professor of health services, policy and practice and of biostatistics at Brown’s School of Public Health. “In practice, this means that some people might decide to take medications even absent rigorous evidence, which could lead to harmful side effects. At the same time, others might avoid medications that could actually help them because there’s not enough data to give them confidence about safety.”

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Source: Brown University School of Public Health, 17 January 2025