Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Jun:63 Suppl 1:S117-S125.
doi: 10.1002/jcph.2226.

Challenges in Conducting Therapeutic Trials in Pregnancy: Emphasizing Recent Lessons Learned

Tracy Caroline Bank  1 , Catherine S Stika  2 , Raman Venkataramanan  3 , Christine Field  1 , Maged M Costantine  1
Affiliations
Review

Challenges in Conducting Therapeutic Trials in Pregnancy: Emphasizing Recent Lessons Learned

Tracy Caroline Bank et al. J Clin Pharmacol. 2023 Jun.

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.

Keywords: COVID-19; clinical trials; fetal safety; maternal autonomy; maternal safety; obstetric pharmacology; obstetric research; statin.

PubMed Disclaimer

References

    1. National Academies of Sciences E and M. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups; 2022.
    1. Baylis F, Halperin SA. Research involving pregnant women: trials and tribulations. Clin Investig (Lond). 2012;2(2):139-146.
    1. McKiever M, Frey H, Costantine MM. Challenges in conducting clinical research studies in pregnant women. J Pharmacokinet Pharmacodyn. 2020;47(4):287-293.
    1. Lupattelli A, Spigset O, Twigg MJ, et al. Medication use in pregnancy: a cross-sectional, multinational web-based study. BMJ Open. 2014;4(2):e004365.
    1. Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernández-Díaz S. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol. 2011;205(1):51.e1-51.e8.

Publication types

Substances

LinkOut - more resources