recruitment – The OptiBreech Project

This week, the first woman planning a vaginal breech birth consented to participate in the OptiBreech 1 study.

What does this mean?

The woman requested to plan a vaginal breech birth, and met the criteria, so her care provider spoke to her about the OptiBreech 1 study. After accessing our Information for Women and Birthing People, the woman agreed to have her data contribute to our study. She completed the on-line consent form, and the professional who counselled her completed the consent confirmation form.

What’s going to happen next?

The local Breech Lead makes a plan for how they will provide care for this birth. Ideally, someone who meets all of the OptiBreech Proficiency Criteria will attend the birth. Where this is not possible, the team will do their best to have someone attend the birth who has completed OptiBreech training.

How will they do that?

In this setting, ensuring experienced support is straightforward. The hospital employs a Consultant Midwife with a special interest in breech birth. She meets all of the Proficiency Criteria, and part of her job role is to attend planned vaginal breech births. While she is not paid for additional time on call, her Head of Midwifery has authorised her to claim time back for any birth she attends outside of her normal working hours.

In order to make the service sustainable, the Consultant Midwife will support the clinical staff caring for the woman to gain experience. Her role is to provide an additional layer of OptiBreech support and safety. Where possible, she will seek to involve another member of the OptiBreech team. This is the group of colleagues who expressed an interest in providing OptiBreech care, through the OptiBreech Interest and Proficiency Survey.

What if the Consultant Midwife can’t make it to the birth?

The expectation is that, where possible, a member of the OptiBreech team will be present for all of second stage at a minimum. For planned breech births, there is usually at least a few hours warning, time enough to sort out who is available to attend. All women are informed that there is not an absolute guarantee, and assisted to think through what might happen if no skilled and experienced practitioner is available.

If the Consultant Midwife can’t make it, she will liaise with her colleagues to determine whether someone else on the OptiBreech team is available. If no other skilled and experienced member of staff who has completed OptiBreech training is available, the woman will be informed of this. She will be counselled by the consultant obstetrician on-call and decide if she would like to proceed with a vaginal breech birth or have a caesarean section, just as she would if she were planning a VBB outside of the study.

If this occurs, and nobody who has completed OptiBreech training is available to attend the birth, this will be recorded on the Case Report Form. The research team will be monitoring this closely so that we can give women an accurate idea of how well they can depend on their birth being attended by someone with OptiBreech training.

There is no ‘penalty’ if a participating site is not able to get someone with the OptiBreech training to the birth. Part of what our feasibility testing will determine is how often this occurs. Women in our PPI group expressed understanding that it may be hard for Trusts to guarantee attendance, especially in the early days, but that they appreciated the willingness to try.

What will happen during the birth?

The OptiBreech team member who attends will lead the birth but liaise closely with the on-call consultant obstetrician, as an additional layer of safety. The team will ensure that the Pro Forma is completed, documenting the care around the time of birth.

What will happen after the birth?

The local Principal Investigator will gather the data from the birth and enter it onto a Case Report Form. This will be securely returned to the research team.

If the woman has consented to a follow-up interview or long-term outcome collection, the research team will be in touch as appropriate.

The short answer: How does it work?

Image courtesy of Dr Anke Reitter, Frankfurt

If staff feel it is in the woman’s best interests to call someone to the birth who has completed the OptiBreech training and/or achieved the proficiency criteria, then they should do so.
When the breech presentation is diagnosed, staff should determine if there is someone available who has completed the enhanced training and/or meets the proficiency criteria, who can attend and support the birth. You can download a Breech Birth Pro Forma to assist with collecting all of the data we need about the birth.
If someone with OptiBreech training has attended the birth, the woman may be approached after the birth and asked for her consent for her data to be used in the study, as per the standard consent procedures. The person has the right to decline use of their data. The Participant Information Sheet and Consent Form are linked from this page (including a video version of the PIS). The password for the on-line Consent Form (preferred) is available from your local Principal Investigator.
Consent should be sought by someone who attended the birth, and they should also offer a thorough debrief of what happened at the birth at this time.

The longer explanation

In OptiBreech 1, we are collecting prospective observational data on planned vaginal breech births, where women and birthing people consent to our use of this data. This will include rates of vaginal birth and adverse outcomes for babies (death or admission to the neonatal unit) and mothers (PPH, severe perineal tears). We will also be looking at how many women plan a vaginal breech birth, and how many are attended by someone who has attended OptiBreech training and/or maintained proficiency-level experience. This will enable us to calculate whether a large trial will be possible.

Many participating sites are just beginning to re-build a breech birth service after decades of not offering such a service. Where overall experience levels are low, some Trusts are expecting to start out with mainly ‘undiagnosed breech births.’ This refers to a situation where the breech presentation is identified for the first time after the person has been admitted in labour. Approximately 20-30% of breech presentations are diagnosed for the first time in labour, or 5% where universal third trimester scanning has been implemented (Salim et al 2021).

The benefit-risk balance of vaginal birth vs caesarean section is altered when a woman is in labour. The findings of the Term Breech Trial indicated that a caesarean section performed prior to the start of labour significantly reduces risks to the baby compared to a vaginal birth (when the classical methods of delivery used in the TBT are used, Su et al 2003). This effect was less significant in early labour but still clear. However, when the woman was in active labour, defined as 3 cm or more, the benefit was less clear and did not reach statistical significance.

A potential benefit from a CS in labour needs to be balanced against known risks to the woman and future pregnancies. Although most women are very willing to sacrifice themselves for any benefit to their baby, a CS performed near to or in the second stage of labour also significantly increases the risks of early preterm birth and late miscarriage in all future pregnancies (Watson et al 2017).

Although many clinicians will still want to offer women a CS if they feel they have time to counsel appropriately, because of the change in benefit-risk balance in labour, the RCOG guideline currently advises that women near to or in the second stage of labour should not routinely be offered a CS. Women in our PPI group also tell us that being asked to decide on the mode of birth for a breech baby in labour, where there is no immediate threat to fetal well-being, is very stressful and can result in birth trauma, even where outcomes are good (Lightfoot 2018).

The OptiBreech study is designed on the premise that getting someone to a vaginal breech birth who has 1) completed an enhanced, evidence-based training package; and/or 2) has acquired proficiency-level experience, is likely to improve the outcomes of both planned and unplanned breech births. Therefore, we have worked into the protocol a way of enabling women with a breech presentation diagnosed in labour to participate, taking account of the RCOG guidance for obtaining valid consent to participate in perinatal research where consent is time critical (2016, see also Vernon et al 2006).

Women in our PPI group expressed that taking consent for participation in labour was not appropriate. As this is an observational, rather than interventional, stage of the study, and attendance of an OptiBreech-trained professional would be something in addition to, rather than replacing, standard care, they felt it was appropriate that women’s consent be taken retrospectively in the postnatal period. Standard counselling about mode of birth, according to RCOG guidelines, would apply in labour.

Women also identified that many found the experience of undiagnosed breech birth traumatic regardless of the outcome, due to the concern staff expressed when discovering their baby to be breech. However, they were rarely offered an opportunity to process what had happened with staff who were present. PPI participants said they felt women would benefit from careful explanations in the postnatal period. We therefore added the last step. We are grateful for the guidance of our PPI group, so that we can make participation in OptiBreech 1 potentially beneficial for women, rather than a burden.

If you have any comments to make about this process, you are welcome to leave them here or contact the research team.