While I was developing this proposal, I sought input from service users in several ways:
- By attending a meeting of the South London Maternity Voices Partnership, organised by Mary Newburn.
- By asking for feedback early in the process from the Birth Trauma Association.
- Making use of the Fast Track Review Service of the NIHR RDS London.
- Through an open call for participation circulated on my professional website and social media.
Ensuring good information
The importance of complete and understandable information about the feasibility trial and about the option of vaginal breech birth was echoed across feedback from all sources. This has been highlighted as the main ethical issue in the Detailed Research Plan.
As the protocol develops, I will engage carefully with those who have indicated an interest in remaining involved in the feasibility study to ensure information meets women’s needs. My colleague Emma Spillane, breech midwife at St George’s Hospital in London, has been developing an information leaflet about options for breech a term. This includes infographics, which women with autism and information processing challenges have fed back is very helpful. I will build on this for the feasibility study.
We will also look carefully at the number of women who are not able to participate in the trial because of informational barriers, such as the inability to understand written English. This will help to understand what translation services, into what languages, we may need to make use of in a full trial to enable equity of participation and access.
Lay reviewers from the RDS London Fast Track Service expressed concern about the legal situation should an adverse outcome occur with a vaginal breech birth. Women in both arms of the trial will be able to choose their preferred mode of birth. The difference is: women under physiological breech birth care will be offered assurance that, if they choose to plan a vaginal breech birth, the team will do everything possible to ensure they are attended by someone who is trained, skilled and experienced in physiological breech birth. In many NHS Trusts, the availability of such support is uncertain, as it depends on who is on shift in the labour ward on any given day/night. Women will be counselled as per the RCOG guideline and local guidelines regardless of their group allocation. They will be informed that we are doing this trial because the available evidence indicates that the physiological breech birth approach may improve access to and outcomes of vaginal breech births, but that we are not certain – hence the need for the research.
Will women participate in this research?
Designing a trial that would produce useful information for women, using methods that were acceptable to women participating in the research, was an important priority to me. The Term Breech Trial46experienced recruitment difficulties, which may have influenced the results.35 Early feedback moved the trial design in a more pragmatic direction, to a design that enables women to have the final say in whether they have an ECV and how they give birth to their breech baby. Another benefit of this design is that it will enable us to study how this new model of care influences women’s perception of the choices available to them.
When we asked those who attended the MVP meeting how many women out of 10 they thought would agree to participate, the range of answers was 5-8, with an average of 6.66. To increase enrolment, MVP members recommended a second recruitment opportunity immediately prior to any scheduled ECVs. This will give women time to think about it, and research midwives ability to identify potential candidates who may not have been offered the opportunity to participate immediately following their scan. This has been incorporated into the trial protocol.
One concern was that all women who participate would want specialist care, and would be disappointed if randomised to standard care. Although making specialist care unavailable outside of the trial is necessary for this design to succeed, and there was general agreement and understanding about this, some women felt it was unfair. For this reason, when a decision is made about whether to proceed to a full trial, we will consider whether randomisation at the individual level has worked. We will compare this to feedback from Trusts who indicate a willingness to participate in a full trial. Following the completion of the feasibility study, we will consider whether the current design will work. If not, and if enough Trusts are keen to participate, another design may be more appropriate, such as a stepped wedge cluster randomised controlled trial. In this type of research, individual Trusts would be randomised to implement physiological breech birth care at different times, rather than individual women.
What about the women who have had negative experiences of breech birth? Or those who are happy with standard care?
Women who respond to a call for involvement in development of a breech birth trial are more likely to have had either positive experiences of breech birth or negative experiences finding a lack of experienced support, for either planned or unplanned breech births.
Thank you to Maureen Treadwell of the Birth Trauma Association for helping me ensure this proposal is informed by the experiences of women who have felt traumatised by not being able to plan a vaginal breech birth, as well as those who have felt traumatised after planning a breech birth that did not go to plan. Women who have had negative experiences of breech birth may be more reluctant to engage in discussions about a breech trial, for very good reasons. Service user advocates like Maureen, who listen carefully to the stories of many women across the UK, help these voices to be heard as we strive to Do No Harm.
Maureen and the BTA highlighted that the goal of any further breech research should be to increase the quality of information and the availability of choice for women carrying a breech baby at term, rather than as part of a strategy that to reduce the CS rate.
This resonated with feedback from the RDS London Fast Track Review Service, through which four public representatives provided a review of two versions of the Plain English Summary. Again, the views of the general public about breech birth research are likely to be different to those held by women who have experienced a term breech pregnancy themselves. One RDS reviewer expressed concern that if physiological breech birth were deemed ‘safe,’ women would feel pressured to choose a vaginal birth rather than a CS, and this would undermine the priority of ensuring women are well supported regardless of their choice of mode of birth.
… to everyone who took the time to respond to my research proposal, to members of South London MVP for giving me permission to share their feedback and to Alison Bish for co-ordinating responses from RDS London. I am extremely grateful and confident the design is better for everyone’s involvement.
If you would like to view the tool I used for the Maternity Voices Partnership Meeting, you can download it here.