Abstract
ObjectiveThe 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. MethodsIn 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. ResultsFour 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. ConclusionsMidwives 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.
Highlights
The concept of informed consent originates from the Nuremberg Code and is a guiding principle in the Declaration of Helsinki [1]
This study describes the experiences of midwives recruiting nullip arous women to an randomized controlled trials (RCTs) assessing the effects of episiotomy on obstetric anal sphincter injury in vacuum-assisted deliveries
Four main cate gories of experiences emerged from a wide array of experiences among the midwives: “Experiences and perceptions of providing trial information,” “The right timing in providing trial information,” “Experiences of how the trial information was received by the women,” and “Perceived trial appre hensions and concerns.”
Summary
The concept of informed consent originates from the Nuremberg Code and is a guiding principle in the Declaration of Helsinki [1]. Informed consent is an accepted standard in clinical research and aims for respect, promoting participant autonomy and protecting participants from harm. Ensuring high levels of informed consent in randomized controlled trials (RCTs) requires considerable commitment from recruiters [2]. Health care providers expressed discomfort and emotions related to the research and their clinical role, and showed strong commitment to the trial and research in general [3]. Training and support are required to ensure recruiters’ understanding of the principles of an RCT and that they can explain the study rationale to potential participants. According to the same study, it is important that recruiters are willing to Abbreviations: EVA trial, Episiotomy in vacuum-assisted delivery trial; RCT, Randomized controlled trial. According to the same study, it is important that recruiters are willing to Abbreviations: EVA trial, Episiotomy in vacuum-assisted delivery trial; RCT, Randomized controlled trial. * Corresponding author at: Umeå universitet, 901 87 Umeå, Sweden
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