Challenges in Conducting Therapeutic Trials in Pregnancy: Emphasizing Recent Lessons Learned
Tracy Caroline Bank, Catherine S. Stika, Raman Venkataramanan, Christine Field, Maged M. Costantine
Abstract
Pregnant people have traditionally been excluded from therapeutic research by restrictions intended for fetal protection. Despite a movement toward inclusion, concerns for the feasibility and safety of including pregnant people in studies continue to limit this research. This article reviews the history of research guidelines in pregnancy and illustrates ongoing challenges, as seen in the development of vaccines and therapies during the coronavirus disease 2019 pandemic and investigation of statins for preeclampsia prevention. It explores new approaches that may be used to improve therapeutic research in pregnancy. A major cultural shift is needed to balance potential maternal and/or fetal risks with potential benefits from participation in research, as well as harm from withholding treatment or providing one that is not evidence-based. Finally, it is important to honor maternal autonomy in decision-making regarding participation in clinical trials.