Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices

TLDR

Pregnant women are a vulnerable group needed in clinical research to advance prevention and treatment options, yet they remain underrepresented. The study uses a socioecological framework to highlight barriers and facilitators to recruiting and retaining pregnant women, and proposes that integrative sampling leveraging prenatal providers can overcome these challenges. The authors employ a socioecological model, trace historical and policy reasons for exclusion, and review integrative sampling methods that leverage prenatal providers to guide recruitment and retention. The findings reveal persistent recruitment and retention challenges and argue that integrative sampling with prenatal providers, coupled with strong community engagement, can improve recruitment and retention in future longitudinal studies.

Abstract

Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.