- How we invited engagement
- Our plain English description of the study
- Feedback, questions and our answers
- Survey results
If you would like to offer feedback privately, you can contact our PPI Lead, Siân Davies. Siân has lived experience of breech pregnancy, is a perinatal psychologist by training, and has additional training in trauma-informed care. Our PPIE team also includes Nimisha Johnstone.
We held two online engagement events in March 2023. These were attended by four women with lived experience of breech pregnancy and planning a vaginal breech birth and two midwives. Additional feedback was obtained via social media channels and a survey. This was how we advertised them:
Monday, 6 March, 2-3.30 pm — via Zoom
Tuesday, 14 March, 6-7.30 pm — via Zoom
Events are open to women and birthing people and maternity care providers throughout the UK.
Below is a description of one of the studies we would like to do. We invite anyone to comment on the study design and description (online survey; will remain open until early May 2023), particularly families that have had a breech-presenting baby within the past 5 years in the UK. We can answer any questions you have during the engagement meetings, or you can contact us via e-mail using the form below.
OptiBreech ECV or no-ECV trial
Approximately 1:25 babies is breech at the end of pregnancy, positioned head-up instead of head-down in the womb. Current standard care is to offer women an attempt at turning the baby to head-down, through pressure on the abdomen (external cephalic version, ECV). However, this procedure is only successful 50% of the time and some women prefer not to try it.
OptiBreech care is delivered through a dedicated clinic, co-ordinated by a breech specialist midwife collaboratively with a breech lead obstetrician. It includes care during labour for women and birthing people who plan a vaginal breech birth (VBB). In our first study of OptiBreech care, women who planned a VBB without a prior attempt at ECV (no-ECV) had higher rates of vaginal birth. In our small trial, women receiving OptiBreech care had higher rates of vaginal birth and better outcomes compared to women receiving standard care, including all modes of birth.
In surveys one month after birth, 61% (27/44) of OptiBreech participants said they would not attempt an ECV in a future pregnancy. OptiBreech clinicians are also uncertain whether trying to turn the baby provides additional benefits, including more vaginal birth and less overall healthcare costs, compared to no-ECV within OptiBreech services.
The aim of this research is to determine if attempting to turn breech babies head-down (ECV) offers additional benefits, compared to OptiBreech care with no-ECV.
The design is a randomised controlled trial. Participants will be women over 36 weeks of pregnancy who wish to plan a vaginal birth regardless of whether their baby remains in a breech position. Those who choose to participate will be allocated by chance (randomised) to one of two options.
The ‘standard care’ group (the control) will have an ECV attempt. If unsuccessful, the person will plan a VBB with OptiBreech care. The experimental group will be no-ECV; these will plan a VBB with OptiBreech care. We will compare these two groups to determine whether the vaginal birth rate differs between them and whether care for one group costs more than care for the other.
Our stakeholders, OptiBreech clinicians, participants and Patient and Public Involvement group members, have highlighted the need for this research. While some women may continue to prefer an ECV attempt, others would prefer not to have one if additional benefits are not clear. This could potentially save healthcare resources or alternatively reassure us that ECV is still important in OptiBreech contexts.
This research is aimed at influencing national guidance. We will work with the Royal College of Obstetricians and Gynaecologists to ensure this happens. We will also share our results with participants and the public through publications and our engagement website, optibreech.uk.
Dr Shawn Walker, OptiBreech Chief Investigator
Stakeholder feedback and questions
From our first engagement event: What happens if someone gets randomised into ECV and they didn’t want this and decides not to go ahead with the plan?
Ideally, we would like people to decide if they will be happy to have an ECV and/or a planned vaginal breech birth before agreeing to participate. However, we respect everyone’s autonomy and ability to withdraw from research interventions. We would continue to include the person’s results (with consent) and would take account of the change of plan in the statistical analysis. The reality of breech care is people often do change their minds, both about ECV and about VBB.
Could woman opt in for ECV or no ECV themselves?
Yes, but not if they are participating in the trial. Randomisation reduces bias by removing the element of choice from both women and clinicians. So participants would need to decide if they are happy to give up that choice, and accept ECV or no-ECV according to the way they are randomised.
If women decide NOT to participate in randomisation but still wish to plan a vaginal breech birth, they will be invited to participate in the observational cohort arm of the study. This option may or may not be available to women booked externally to participating centres, depending on whether OptiBreech care is considered the standard of care or an experimental treatment (on-study only) within that hospital. It may also depend on the team’s capacity.
From our first engagement event: If someone has had a previous caesarean birth but they would like this birth to be vaginal, could having an ECV cause issues because of the previous birth mode i.e. ruptured membranes etc?
Having an ECV after one caesarean appears to be safe, and the current RCOG guidelines recommend this is offered. Regardless of previous mode of birth, approximately 1:200 women (0.5%) require an emergency caesarean birth immediately following the procedure, due to complications. Having an external cephalic version prior to 36 weeks may increase the rate of preterm birth.
From our first engagement event (midwife stakeholder): Computer randomisation does reduce clinical bias, however would the clinical midwife involved in the study increase bias by them recruiting participants?
Yes! This bias could go either way. Sometimes people are not recruited because, for example, the clinician does not feel it would be appropriate to offer them one option or another. Sometimes there is confusion about inclusion criteria so that women at moderate risk (eg. one previous caesarean birth) are not offered the opportunity to participate. To counter-act this potential source of bias, we will create posters for recruiting sites to display in areas where women receive antenatal care, providing them with a neutral point of contact, such as a research midwife. We will also share information on this website about how women can self-refer onto the study. This will enable as many women to access the research as possible and limit the bias from clinician selection.
From our online survey: How do people get consented to the randomisation?
Great question! The health care professional who informed the person about the research would offer further written information and the opportunity to ask questions. Then we would ask for consent, usually online, directly onto our database via the participant’s personal e-mail, which is also used for follow-up surveys. Alternatively, consent can be taken via written signature on the same consent form, on paper. An example of the participant information sheets and consent forms we currently use can be found on our Information for Women and Birthing People page.
In some settings, OptiBreech team care has become the standard of care. In others, it is still considered an experimental care pathway within the service, with the service funded by clinical research network funds. In the latter case, OptiBreech care would only be available through participation in the research.
From our online survey: I’d want more information about what OptiBreech is, but appreciate this may confound the research.
We want participants in this research to have a very clear idea about what OptiBreech Care is. We explain it in our participant information sheets, which are similar to those we would use in this research. These can be found on our Information for Women and Birthing People page.
Questions about breech birth at home
From our online survey:
What about those who wish to birth at home?
I suspect the research will take place in hospital, but that hasn’t been made clear.
Supporting women in any location.
Any data on VBB home birth.
Our OptiBreech Guideline recommends birth in hospital, within an obstetric unit. However, this is not required. We neither require women to give birth in hospital nor require local OptiBreech teams to attend births outside of the hospital. As with most standard breech criteria, our approach is to observe rather than to control. Women on our study have chosen to give birth in the full range of settings available to all other women, although sometimes the ability to do this is affected by local staffing constraints. It is too early to offer information about how place of birth influences results for OptiBreech care.
The OptiBreech position on home breech birth is fully explained in this video blog.
From our online survey: Does this include footling breech presentation? As all basic literature I have found suggests c section always offered with these.
You are absolutely correct that this has been the traditional approach. But our approach is to base all of our guidelines on evidence.
Our view of the literature is that ‘footling’ presentation is poorly and inconsistently defined, making it difficult to draw conclusions about risk. Increased risks pre-term (before 37 weeks) are clear, but the available literature indicates that non-extended (non-frank / both legs straight beside the body) presentations may actually have BETTER outcomes at term. We therefore do not recommend a caesarean birth unless the feet are presenting and the baby’s pelvis is not engaged, eg. positioned above the inlet to the maternal pelvis. We call this position, ‘standing.’
When baby’s legs are flexed (bent), we counsel women about the increased risk of a cord dropping down in labour, which would require a caesarean birth if it happened. And we explain the clinical uncertainty, eg. we do not know for certain whether there is increased risk or not.
Instead, we collect data about what position baby’s legs are in during antenatal scans and what position the legs are in at birth, and of course what the ultimate outcome is. In that sense, yes, footling breech presentation is included, and not excluded, from this research.
Questions and feedback from Amy Weatherup, administrator of the Breech Birth UK Facebook Group.
Answers from Shawn in blue.
Some questions about your study design:
How will you record babies that turn by themselves without an attempted ECV or after a failed ECV?
In the OptiBreech database, we record: 1. Initial plan after first counselling – ECV/VBB/CB; Result of all ECVs planned – not done (and reason)/successful/unsuccessful
Will you allow a 2nd ECV after a failed ECV?
Yes, all women who request an ECV are offered a 2nd attempt (for those women randomised to the ECV arm only).
What will your approach be to other turning methods eg spinning babies, moxibustion, Webster’s technique?
In the OptiBreech database, we record: 1. Counselling, advice, information and other items (eg. moxa sticks) women have been given antenatally; 2. What women report having used in pregnancy in a follow-up survey 1 month after birth
One of our OptiBreech team members is currently analysing this data for her Masters. We think this would make an excellent PhD for a midwife (trial of one or more complementary methods). https://optibreech.uk/2022/10/19/researching-how-to-encourage-breech-babies-to-turn/
Will women have to agree not to try them or will they be allowed or even encouraged? In either case the data on what else they try will need to be collected.
Currently, the OptiBreech care pathway does not include specific advice on complementary therapies. We are collecting observational data on their use only. We will neither be requiring women not to try complementary therapies nor encouraging them to do so.
Hope that helps! Keep up the good work!!!
OptiBreech is helping so many women that are coming through our group – I hope you can find a way to make it more widely adopted once the research is completed (but I realise the NHS is slow…)
We are working on that too! Watch this space …
Responses to the online survey
Other: I experienced undetected footling breech presentation and delivered vaginally at home prior to midwife arrival due to rapid labour. Just over 2 months ago.
Q1 – What do you like about this study?
|I felt like my only option was elective c-section so this would have been great to support a vaginal breech birth for me|
|I am interested to know if not attempting an ECV would lead to better outcome. And how good are the outcomes for mum and baby in BVV.|
|Having options to birth vaginally rather than being told you must have a c section. That there will be specialists in breech aginal delivery|
|That it could support trusts to support VBB|
|The encouragement of the use of natural breech birth|
|The results can influence that women should not be forced into an ECV automatically. Autonomy is so important|
|Each study arm has an emphasis on vaginal birth; the study will collect good data on the outcomes of VBB attempts in general and this will allow more birthing people to consider a VBB, with or without ECV.|
|It could provide some insight to the reality of the benefit of ECV rather than a perceived benefit. Any additional information on breech birth will help empower women with their birth choices.|
|I like that methods other than ecv are being looked at.|
|Its taking a good look at optimum care for women with a breech presentation, acknowledging that they may want a vaginal birth and this is a perfectly reasonable option.|
|It is lookind xarefully at the impact of ECV. It is supporting vaginal breech birth|
|I like that women would be allowed to make an informed choice without being pressurised into what they don’t want, considering there are no further risk factors involved|
|It looks at the clinical benefits and outcomes of a procedure which is often just assumed, or denied without a real discussion|
|Providing more data on the benefits of an ECV to allow people to make informed choices|
|I like the idea that in one group the baby decides- if it stays breech it can be born breech. I like that both groups will get to birth vaginally|
Q2 – Did anything concern or worry you?
|No. But I know some women worry about ECV. I had one (which didn’t work) so I’m not bothered.|
|What about thoae who wish to birth at home?|
|No, I think this is well thought out research|
Q3 – Was there anything you needed more information about, or felt was unclear in the summary?
|Note: Where participants expressed questions, we answered these above.|
|Does this include footling breech presentation? As all basic literature I have found suggests c section always offered with these.|
|How do people get consented to the randomisation|
|I’d want more information about what OptiBreech is, but appreciate this may confound the research. I suspect the research will take place in hospital, but that hasn’t been made clear.|
|No, it was all clear|
Q4. If we asked 10 women or birthing people who prefer a vaginal birth if they would like to participate in this study, how many of these 10 women do you think will agree to participate?
- Minimum: 4
- Maximum: 10
- Mean: 8
- Standard deviation: 1.9
Q5. If you were pregnant with a breech baby, would you participate in this study?
Q6 – Why do you feel this study will be acceptable, or not?
|I think it’s acceptable, it’s an interesting topic|
|Acceptable because it gives women choices with their bodies and births which reduces trauma surrounding a lack of control to try birth vaginally|
|Anything that gives women autonomy is so important, as they have to deal with the consequences of it. You shouldn’t be made to feel that is the only option|
|Dedicated care for breech presentation to optimise the chances of a successful vaginal birth in both arms.|
|It may be tricky because VBB can be taboo, and offering ECV is a standard of care. Some women may feel they are not giving themselves the best chance if they don’t attempt an ECV|
|Some women won’t want to risk having an ECV.|
|If birthing people have strong feeling ref ECV they may withdraw if allocated to the ‘wrong’ group.|
|It allows women making informed choice whilst considering research data and risk factors|
|This is a really vulnerable time in a pregnancy. Women often have ideas about how they are going to give birth, they are often told for weeks/months don’t worry baby has lots of time to turn and then suddenly it’s all systems go for a c section. It should be talked about more throughout with real tangibility of success rates and impacts|
|Support of the OptiBreech team will mean candidates are more likely to support a randomised study as they will feel well cared for by experts|
|I’m both groups there is clearly good care and support from a breech team|
Q7 – Is there anything else you would like us to prioritise for OptiBreech research?
|I would like to learn more about the outcomes of the VBB when attempted with help of an experienced team.|
|The collection of evidence to support VBB and VBac|
|Could woman opt in for ECV or no ECV themselves?|
|Any data on VBB home birth.|
|Supporting women in any location.|
|Getting all hospitals to offer real choice to pregnant women|
We also asked for permission to include the quotes provided in our report. Thank you to all those who have helped us to shape this research and our on-going projects.