Discussion
RECRUITMENT, SAID
This study aimed to explore women’s and obstetricians’ views on the acceptability and feasibility of an RCT examining different approaches for managing an impacted fetal head during emergency CS, as well as views on the two RCT designs proposed. Results found women and obstetricians thought a trial was important and most thought it would be acceptable and feasible. However, they raised a number of issues for consideration under four areas of Recruitment and consent considered the issue of when consent is obtained and the difficulty of trying to do it under emergency situations. Women thought a good time to provide information about the RCT was in the second trimester when more detailed information could be given and they had time to ask questions and consider it fully. Women and obstetricians also raised the importance of the content and format of information being tailored to the circumstances under which it is given. These findings are consistent with previous literature [Proposals for gaining consent in emergency circumstances therefore include deferred consent where women are randomised prior to the procedure and consent is asked for afterwards [The area of feasibility and acceptability included potential barriers and facilitators to getting health professionals and women to conduct or take part in the RCT. Barriers were predominantly the conflict between the preferred techniques or practices of obstetricians and obstetric units and the RCT protocol. Facilitators were the attractiveness of being provided with fetal pillows (in units where they did not have them), good training in the techniques included in the RCT, and the ability to over-ride the RCT protocol in critical situations where clinical judgement and safety warranted it. Women also said they would trust health professionals to use the most appropriate technique and abandon the RCT protocol if necessary. The importance of good training in trial procedures/techniques is well recognised [Design considerations showed there were varying views on which of the two RCT designs would be preferred – and advantages and disadvantages to each. There are two potential timings of the intervention: 1) using prophylactic or early dis-impaction prior to starting the CS when the vaginal examination findings suggest there may be an impacted fetal head 2) ‘treatment’ or late dis-impaction after delivery has been attempted at CS. The choice of design depends on whether the aim is to evaluate the effectiveness of techniques to manage impacted fetal head before or during CS. One technique for managing an impacted fetal head is the fetal pillow which takes 60s to insert. This may make it less appropriate to use for ‘treatment’, as it would delay the uterine incision to delivery interval, although previous research suggests it results in similar [A range of important maternal, infant and clinical outcomes were raised by women and obstetricians. These were slightly different in focus, with women focusing on wellbeing and safety of themselves and the infant, as well as the experience. Outcomes mentioned by obstetricians were more clinically focused and specific but most were consistent with women’s concerns. Choice of outcomes for the trial will be guided by this work and a Delphi process and expert consensus meeting which was undertaken to reach consensus on which outcomes should be chosen for a trial.