Episiotomy or not? Midwives' experiences of recruiting to a randomized controlled trial during pregnancy and labor - A qualitative study.

OBJECTIVE: The performance of randomized controlled trials (RCTs) is dependent on recruitment. Recruiting women to RCTs regarding interventions during childbirth may be difficult due to time constraints and their vulnerable situation. Midwives play a major role in such recruitment. Few studies have investigated the views and experiences of recruiters. The aim of this study was to describe midwives' experiences of recruiting pregnant women regarding an RCT of lateral episiotomy or no episiotomy in vacuum-assisted delivery. METHODS: In this qualitative study, 19 midwives were interviewed regarding their experiences. The midwives worked at antenatal health care centers or labor wards. The transcribed interviews were analyzed using content analysis. RESULTS: Four categories appeared during the analysis, including "experiences and perceptions of providing trial information" and "the right timing in providing trial information," which varied among the midwives. Midwives' perceptions of how the women provided consent or declined participation, and the women's views and questions about the randomization and intervention, were summarized as "experiences of how the trial information was received by the women." In the final category, "perceived trial apprehensions and concerns," some midwives described ethical concerns related to the intervention and financial compensation to the staff involved. CONCLUSIONS: Midwives as recruiters would benefit from education and training in incorporating basic and advanced details of trial design and research methods, as well as training and support in recruitment. Awareness and management of the variation among potential recruiters is important when designing and performing an RCT.