Considering the timing and appropriateness of trial consent during childbirth: A secondary analysis from the qualitative process evaluation of the ROTATE trial

Background: The ROTATE Trial is a multi-centre randomised controlled trial of manual versus instrumental rotation of the fetal head in malposition at birth, to evaluate if manual compared with instrumental rotation reduces the risk of severe maternal perineal trauma, without increasing caesarean birth rates. ROTATE internal pilot phase ran from June 2022 – June 2023 with an embedded qualitative process evaluation (QPE). The QPE aimed to explore the feasibility, acceptability, and appropriateness of the trial for parents and healthcare professionals (HCPs). ROTATE had a two-stage consent process where verbal assent was sought prior to randomisation, and written consent was gained and recorded after the birth. This paper reports a secondary analysis of ROTATE QPE data focusing on gaining informed consent to trial entry in time-pressured maternity settings.
Methods: Secondary analysis of data from semi-structured interviews with women (n=9), their birth partners (n=3) and HCPs (n=11). Data were analysed using codebook thematic analysis.
Results: Parents and HCP reported that offering a clinical trial at late-stage labour added additional complexities and challenges at a time-pressured period of their labour and birth. Using a layered approach to trial offering, where the trial information was shared prior to full eligibility, and discussed with multiple trusted HCPs, meant clinical trial approaches in late-stage labour can be anticipated. HCPs were concerned whether parents would recall conversations and decision-making about trial entry when they had been under physical and psychological stress in the second stage of labour. The two-stage consent process for ROTATE, using pre-randomisation verbal assent, with post randomisation and post-birth written consent was considered acceptable to parents and pragmatic for HCPs delivering the trial. Gaining subsequent written consent, combined with appropriate birth partner support at the time of trial approach, was considered supportive of autonomous decision-making for women/birthing parents.
Conclusions:
Clinical trial approaches in time-pressured maternity settings may be ethically challenging and add additional complexities at an already stressful time. A two-stage consent process, and early, layered information about the potential for participation in intrapartum clinical trials, supported informed consent and autonomous decision-making for women/birthing parents.
Trial registration: ISRCTN10193017