Page last updated August 10, 2026
Study Design: Retrospective Observational Study
Principal Investigator: Chengxi Zang
PCORnet® Network Partner: INSIGHT
Funder: Federal (NIH)
Therapeutic Area: Obstetrics and Gynecology
Research Question(s):
Pregnant women have been routinely excluded from trials due to ethical and safety concerns. Nearly 95% of clinical trials submitted to the FDA excluded pregnant women. By contrast, almost all pregnant women take at least one medication in pregnancy, but trial evidence on the safety and efficacy of these medications is largely missing. Such evidence gaps present challenges for clinicians who advise treatment for pregnant women, and patients who are making decisions in the absence of data to inform safety and efficacy in pregnancy.