Recruitment and Retention of Urban Pregnant Women to a Clinical Study Administering an Oral Isotope Dietary Tracer

Abstract

Introduction: Pregnant women are a vulnerable population that are difficult to engage in clinical research. We report successful recruitment and retention strategies used in a longitudinal pilot study of urban racially/ethnically diverse pregnant women that involved administration of an orally ingested isotope tracer, multiple venipunctures, biopsy of placenta after delivery, and cord or placental blood collection. Materials and Methods: We used direct strategies to recruit English-speaking obese and nonobese pregnant women aged 17?45 years, who were in the third trimester of pregnancy. The study required data collection at 32?34 and 34?36 gestational weeks and delivery. Strategies included frequent personal engagement with participants and staff to build relationships and trust, tangible appreciation, and the study team being present at delivery. In addition, leveraging hospital information technology (IT) services was critical to ensure retention through labor and delivery (LD). Results: A racially (52% Black, 23% White, and 10% other) and ethnically (15% Hispanic or Latinx) diverse sample of pregnant women was enrolled. Of the 52 women enrolled, 85% of women completed all procedures. Conclusions: This is the first report of successful strategies for recruitment and retention of racially/ethnically diverse pregnant women in a longitudinal study requiring oral administration of an isotope tracer. Personal engagement with multiple touch points, starting with recruitment and continuing regularly throughout the third trimester, was the most successful strategy. Creating and maintaining relationships with the LD providers and staff and utilizing hospital IT, including targeted electronic medical record alerts, ensured successful retention for the duration of the study. Trial Registration: Not applicable.

Keywords

• iron isotopes
• maternal?fetal exchange
• obesity
• patient selection
• pregnancy
• recruitment