title: Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices.
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.
authors.affiliation: Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases Emory Rollins School of Public Health, Department of Behavioral Sciences and Health Education, Emory University, Atlanta, Georgia.
authors.forename: Paula M
authors.initials: PM
authors.lastname: Frew
authors.affiliation: Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases.
authors.forename: Diane S
authors.initials: DS
authors.lastname: Saint-Victor
authors.affiliation: NIH Office of Research on Women's Health.
authors.forename: Margaret Brewinski
authors.initials: MB
authors.lastname: Isaacs
authors.affiliation: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
authors.forename: Sonnie
authors.initials: S
authors.lastname: Kim
authors.affiliation: Duke University, Durham, North Carolina.
authors.forename: Geeta K
authors.initials: GK
authors.lastname: Swamy
authors.affiliation: University of Texas Southwestern Medical Center, Dallas.
authors.forename: Jeanne S
authors.initials: JS
authors.lastname: Sheffield
authors.affiliation: Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Edwards
authors.affiliation: MedImmune, Gaithersburg, Maryland.
authors.forename: Tonya
authors.initials: T
authors.lastname: Villafana
authors.affiliation: Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases.
authors.forename: Ouda
authors.initials: O
authors.lastname: Kamagate
authors.affiliation: Department of Obstetrics and Gynecology, University of Kansas Medical Center, Kansas City.
authors.forename: Kevin
authors.initials: K
authors.lastname: Ault
mesh_terms: D000328:Adult; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D018579:Patient Selection; D011247:Pregnancy; D037841:Pregnant People
keywords: clinical research trials; pregnant women; recruitment; retention; vulnerable populations