Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials

Abstract

Clinical research in the pregnant population allows for delivery of quality, evidence-based care in obstetrics. However, in recent years, the field of obstetrics has faced severe challenges in the recruitment of the pregnant population into clinical trials, a struggle also shared by several other medical disciplines. We candidly describe our failure to recruit a healthy population of overweight and obese pregnant women in their first trimester. We were then able to glean unsuccessful and successful recruitment approaches and improve our recruitment effort by autopsy of failed strategies and with guidance from a survey disseminated to improve our understanding of community feelings about participating in research while pregnant. These "lessons learned" taught us that active recruitment within this population is a necessity; that is, direct (face-to-face discussions at obstetric appointments) compared with indirect (flyers and general emails) modalities and that prenatal care provider support of the proposed research study is vital to a patient's willingness to participate. By implementation of "lessons learned," we describe how we successfully recruited a similar pregnant population 1 year later. The Clinical Trials related to our article are as follows: 1) Expecting Success: NCT01610752, https://ichgcp.net/clinical-trials-registry/NCT01610752; 2) MomEE: NCT01954342, https://ichgcp.net/clinical-trials-registry/NCT01954342; and 3) Participate While Pregnant Survey: NCT02699632, https://ichgcp.net/clinical-trials-registry/NCT02699632.

Conflict of interest statement

Financial Disclosure

The authors did not report any potential conflicts of interest.

Each author has indicated that he/she has met the journal’s requirements for authorship.

Figures

Figure 1

Proportion of recruitment methods which identified the actual enrolled participants in the Expecting Success and MomEE studies; “New OB” = these enrolled participants learned about the study through face-to-face discussions with study staff and prenatal care providers at early obstetric appointments (i.e. “New OB”).