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Updated: Dec 23, 2025

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
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Challenges in conducting clinical research studies in pregnant women

Monique McKiever1, Heather Frey1, Maged M Costantine2

  • 1Division of Maternal Fetal Medicine, Department Obstetrics & Gynecology, The Ohio State University Wexner Medical Center, 395 W12th Avenue, Columbus, OH, 43210, USA.

Journal of Pharmacokinetics and Pharmacodynamics
|April 20, 2020
PubMed

Maternal mortality and morbidity continue to rise in the United States. Despite these trends there are limited novel interventions to investigate and improve these metrics, partly due to research protocol limitations which restrict participation of pregnant women. Inclusion of pregnant women in research studies is integral to the process of obtaining important information regarding the safety and efficacy of therapeutics or interventions to improve maternal health and pregnancy outcomes. While significant changes in research practices have resulted in an increase of female participants, there remains a paucity of research trials directly targeting pregnant and lactating women. This article provides an overview of issues surrounding inclusion of pregnant or breastfeeding women in research studies, and includes historical perspectives, navigating concerns over safety profile, considerations for appropriate development, and future perspectives.

Keywords:
BreastfeedingClinical researchDrug developmentObstetricsPharmacologyPregnancy

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