Women’s and midwives’ views on the optimum process for informed consent for research in a feasibility study involving an intrapartum intervention: a qualitative study

Abstract

Abstract Background Recruitment to intrapartum research is complex. Women are expected to understand unfamiliar terminology and assess potential harm versus benefit to their baby and themselves, often when an urgent intervention is required. Time pressures of intrapartum interventions are a major challenge for recruitment discussions taking place during labour, with research midwives expected to present, discuss, and answer questions whilst maintaining equipoise. However, little is known about these interactions. An integrated qualitative study (IQS) was used to investigate information provision for women invited to participate in the ASSIST II feasibility study investigating the Odon Device - a novel device for use in assisted vaginal birth with an aim to generate a framework of good practice for information provision. Methods Transcripts of in-depth interviews with women participants (n=25), with recruiting midwives (n=6) and recruitment discussions between midwives and women (n=21), accepting or declining participation, were coded and interpreted using thematic analysis and content analysis to investigate what was helpful to women and what could be improved. Results Recruiting women to intrapartum research is complicated by factors that impact on women’s understanding and decision making. Three key themes were derived from the data: i) a woman centred recruitment process, ii) optimising the recruitment discussion and iii) making a decision for two. Conclusion Despite evidence from the literature that women would like information provision and the research discussion to take place in the antenatal period, intrapartum studies still vary in the recruitment processes they offer women. Particularly concerning is that some women are given information for the first time whilst in labour, when they are known to feel particularly vulnerable, and contextual factors may influence decision making, therefore we propose a framework for good practice for information provision for research involving interventions initiated in the intra-partum period as a woman centred, and acceptable model of recruitment, which addresses the concerns of women and midwives and facilitates fair inclusion into intrapartum trials. Trial registration ISRCTN This qualitative research was undertaken as part of the ASSIST II Trial (trial registration number: ISRCTN38829082. Prospectively registered 26/06/2019).