Recruiters' perspectives of recruiting women during pregnancy and childbirth to clinical trials: a qualitative evidence synthesis

Vivienne Hanrahan* (Corresponding Author), Katie Gillies, Linda Biesty

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)
6 Downloads (Pure)


Research on research is key to enhancing efficacy in trial methodology. Clinical trials involving women during pregnancy and childbirth are limited, with a paucity of data guiding evidence-based practice. Following a prioritisation exercise that highlighted the top-ten unanswered recruitment questions, this qualitative evidence synthesis was designed specifically to focus on the barriers and enablers for clinicians/healthcare professionals in helping conduct randomised trials within the context of recruitment during pregnancy and childbirth.

The synthesis was undertaken using Thomas and Harden’s three stage thematic synthesis method and reported following the ENTREQ guidelines. Using a pre-determined SPIDER strategy, we conducted a comprehensive search of databases; Pubmed, CINAHL, PsycINFO, EMBASE, and grey searches for records until January 2019. We included all reports of qualitative data on recruiter’s experiences, perceptions, views of recruiting women during pregnancy and childbirth to clinical trials. Altogether 13,401 records were screened, resulting in 31 full-text reviews, of which five were eligible for inclusion. Quality was appraised using CASP. Data were extracted onto a specifically defined form. We used thematic synthesis to identify descriptive and analytical themes, and to interpret and generate theory. Confidence was assessed using GRADE-CERQual. The review protocol is publicly available (OSF

Five papers (representing four individual studies) from two different countries were included. All studies focused on the experiences of trial recruiters in the maternity setting. We identified four analytical themes; Recruitment through a clinician’s lens, Recruiters judgement on acceptability, From protocol to recruiters lived experience, Framing recruitment in context. These were linked by an overarching theme combining beliefs and power.

The overarching theme combining beliefs and power links the experiences and perceptions of recruiters. This synthesis shows a gap between the trial design study protocol and the recruiter’s lived experience. Strategies such as collaborative trial design, mitigating gatekeeping behaviours, and training may support recruiters in their endeavour.
Original languageEnglish
Article number0234783
Number of pages25
JournalPloS ONE
Issue number6
Publication statusPublished - 19 Jun 2020

Bibliographical note

Funding: This paper forms part of doctorial research project supported by the Health Research Board Trial Methodology Research Network (of Ireland) PhD scholarship awarded to VH. The manuscript represents the views of the named authors only. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.


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