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://clinicaltrials.gov/ct2/show/NCT01610752; 2) MomEE: NCT01954342, https://clinicaltrials.gov/ct2/show/NCT01954342; and 3) Participate While Pregnant Survey: NCT02699632, https://clinicaltrials.gov/ct2/show/NCT02699632.
Support by their prenatal care providers is critical to recruitment of pregnant women into clinical trials.
Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana.
Corresponding author: Leanne M. Redman, PhD, FTOS, 6400 Perkins Road, Baton Rouge, LA 70808; email: Leanne.Redman@pbrc.edu.
The MomEE trial is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (R01DK099175). Lifestyle Interventions for Expectant Moms (LIFE-Moms) is supported by the National Institutes of Health through the NIDDK (U01 DK094418 [L.M.R.; Expecting Success], U01 DK094463, U01 DK094416, 5U01 DK094466 [RCU]), National Heart, Lung, and Blood Institute (U01 HL114344, U01 HL114377), Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01 HD072834), National Center for Complementary and Integrative Health, the National Institutes of Health Office of Research in Women's Health, the Office of Behavioral and Social Science Research, the Indian Health Service, and the Intramural Research Program of the NIDDK. Also supported in part by 1 U54 GM104940 from National Institute of General Medical Sciences, which funds the Louisiana Clinical and Translational Science Center. Elizabeth F. Sutton is supported by F31HD084199.
Financial Disclosure The authors did not report any potential conflicts of interest.
The authors thank the LIFE-Moms consortium members for their contributions to the development and oversight of the common measures and procedures shared across the trials.
Each author has indicated that he or she has met the journal’s requirements for authorship.