How safe is it to plan a vaginal breech birth with OptiBreech collaborative care?: analysis of cumulative data within the OptiBreech Multiple Trials Cohort

Introduction

OptiBreech collaborative care is a specialist, multi-disciplinary care pathway for women and birthing people with a breech-presenting fetus at term, developed out of previous research and in collaboration with service users and clinicians^1–4.

Approximately 1 in 20 pregnant women have a breech presenting fetus at the end of pregnancy. Babies are at higher risk of poor outcomes, regardless of the mode of birth⁵. Mothers experience increased rates of surgical delivery and birth trauma. Balancing these risks through person-centred care, centred on the person’s values and life context, is improved when obstetricians and midwives have skill and experience in vaginal breech birth (VBB). Due to the way services are currently delivered in standard services, experience is difficult to acquire.

Variations in skill and experience are dangerous and expensive. In 2021–22, the National Health Services’ (NHS) financial liabilities for claims of obstetric negligence causing cerebral palsy was £36.8 billion⁶. Twelve percent of obstetrics claims for cerebral palsy relate to poorly managed VBBs, despite representing only 0.3% of total births⁷. Our team developed an evidence-based management algorithm that aims to reduce the leading cause of breech birth-related injury: asphyxia^8–10.

Current NHS strategies to reduce risk focus on reducing the numbers of VBBs, through external cephalic version (ECV, turning the baby head-down) and/or planned caesarean birth (CB)¹¹. An unintended effect has been decline in health care professionals’ skills¹². This strategy has reduced the VBBs we can anticipate, resulting in a lack of learning opportunities for staff to safely manage those we cannot predict. Due to maternal choice, lack of universal diagnosis by ultrasound scan¹³, and late-changing fetal positions (unstable lie), VBBs continue to occur, but their rarity makes them vulnerable.

OptiBreech collaborative care is an alternative strategy. The strategy is to support women who choose to plan a VBB, prepare for these births and manage them according to our algorithm. Professionals with advanced training in physiological breech birth^14,15 attend VBBs whenever possible. The service is co-ordinated by a Breech Specialist Midwife^1,4 with support from a Breech Lead Obstetrician. A small, experienced team provides continuity for women and professionals²; their role is to train and support the wider team. This practice includes the option of upright maternal birthing positions^4,16.

Within the OptiBreech collaborative care pathway, women are offered all guideline-recommended options: VBB, ECV, and planned CB. Women find this service beneficial, regardless of their mode of birth¹. Due to substantial differences in clinical practices and the way services are delivered, OptiBreech care is expected to result in different safety outcomes from standard care. The current logic model and TIDieR checklist¹⁷ for OptiBreech collaborative care have been reported in previous publications^1,18. The OptiBreech training package has been described in detail in evaluation publications^14,15. The OptiBreech Clinical Practice Guideline is included in the protocol uploaded to the ISRCTN registration¹⁹. Much of this information is also available on the project’s engagement website, optibreech.uk.

Patient and Public Involvement and Engagement (PPIE) work aimed to ensure the study’s design, analysis, reporting, and interpretation were influenced by women who have lived experience of planning or attempting to plan a VBB. Previous research indicated this population was least well served within current NHS standard care, and this work aimed to improve their outcomes and experience of care^1,20–22, while maintaining choice and good outcomes for all women using the service.

This paper reports an interim analysis of all data available within the OptiBreech database to 8 September 2023. The purpose of reporting this analysis is to provide women and clinicians with as much up-to-date information as possible about what they can expect when planning a VBB with OptiBreech care. We have chosen this publication venue (NIHR Open Research) to enable transparent reporting and updating as the cohort grows, so that all stakeholders have contemporaneous information on which to base decisions.

Methods

Currently included studies

Studies currently included in the OptiBreech database are listed below and summarised in Figure 1: Participant Flow

Figure 1. Participant Flow.

1) The OptiBreech Care Trial: a feasibility study for a pragmatic trial of care for women with a breech-presenting baby at term. Randomised participants (68) were recruited between 10 January 2022 and 09 June 2022. Inclusion and exclusion criteria were more narrowly defined and are reported in detail in the pilot trial report²⁸. Cohort participants were recruited until 8 September 2023 and focused on women who preferred to plan a VBB regardless of whether their baby remained in a breech position. This study was funded by the UK National Institute for Health and Care Research (NIHR, 300582) and sponsored by King’s College London. Ethics approval was obtained from the West London & GTAC Research Ethics Committee (21/LO/0808, 19 November 2021). The pilot trial was prospectively registered with the ISRCTN (14521381, 18 October 2021)¹⁹. The full protocol is available on the trial registration page¹⁹.

Results

Results are presented by sub-group analysis category. With each table, we include the key questions the analysis seeks to answer, by stakeholder group. In all instances, it is not yet possible to detect any significant differences between groups, due to the small sample size.

Discussion

Data available as of 8 September 2023 indicate that providing support for planned VBB within an OptiBreech collaborative care pathway has been as safe as a planned cephalic birth in the same hospitals. While this is the largest data set of planned vaginal breech births published in the UK since 2005²⁹, the sample size is still too small to evaluate rare but important outcomes, such as severe neonatal morbidity or mortality. The Royal College of Obstetricians and Gynaecologists (RCOG) guideline estimates that perinatal mortality following planned caesarean birth at 39 weeks is 0.5/1000, following planned cephalic birth is 1/1000, and following planned vaginal breech birth is 2/1000⁵. Evaluating OptiBreech care for this outcome will require thousands of births. Our intention with the multiple trials cohort is to facilitate multiple nested randomised controlled trials to answer important questions about breech care with different endpoints, while accumulating a sufficient sample to evaluate rare outcomes such as perinatal mortality. This will refine the OptiBreech care pathway for maximum efficiency and effectiveness, for all women requiring breech care.

Prior to the start of this cohort, two preliminary studies were done. The first evaluated the OptiBreech training package (‘Physiological Breech Birth’) within NHS settings¹⁵. This observed a serious neonatal morbidity rate of 0/21 (same composite, 0%) among births attended by an OptiBreech trained attendant, compared to 5/69 (7.2%) among births where the attendant had NOT attended the training¹⁵. This suggests the results of the Term Breech Trial are still relevant to standard care within the UK³⁰.

The second evaluated the feasibility of implementing OptiBreech collaborative team care for planned VBBs¹⁸. In this study, among 82 planned VBBs, one serious adverse outcome (same composite, 1.2%) occurred. In the OptiBreech cohort reported in this paper, 97 women have planned a VBB, with no serious adverse neonatal outcomes. We have therefore reported 200 prospective VBBs across three studies, with one serious adverse neonatal outcome (0.5%). This is very near to the rate of adverse outcomes observed among low-risk women planning cephalic (head-first) births in the UK-based Birthplace in England study (0.43%)³¹. Neonatal admission rates across the feasibility studies following planned VBBs have been below 5%, similar to rates for all term births in the UK³².

We feel our results so far are due to strong qualitative work to develop the programme theory for the OptiBreech collaborative care model. Our logic model was developed and refined through: frequent and meaningful PPIE activities; systematic reviews to establish background, questions and women’s experiences^8,22,33; Delphi consensus methods, including clinicians and service users, on core competencies and important outcomes^{4,16,24,25,34}; grounded theory methods to describe how clinicians learn breech skills^2,3; feasibility work to prepare for a substantive clinical trial^1,18; and a pilot randomised trial²⁸.

Detailed observational work also theoretically underpins our practice guidelines, including video analysis and case control studies to define ranges of ‘normal’ in breech births^8–10. The OptiBreech Algorithm aims to reduce the leading cause of breech birth-related injury: asphyxia^8–10. Our team has raised concerns previously that current guidelines are not optimally safe^10,35. Historically, breech practice has not been based on evidence, particularly around the expected time intervals as the breech baby emerges⁸. This is the fourth paper in which we report that, in most cases with good outcomes, the birth has completed within three to five minutes of the birth of the fetal pelvis^9,10,18. We strongly feel this should be regarded as ‘normal for breech.’

Our OptiBreech guideline continues to recommend attendants aim for the birth to be complete within five minutes from the birth of the pelvis, including time for manoeuvres. It is especially important for novices, who are inherently less confident to intervene, to have clear guidelines that alert them when a threshold of increased risk is approaching. Current RCOG⁵ and PROMPT³⁶ guidelines recommend assisting only after five minutes have passed following birth of the pelvis and emphasise a ‘hands off’ approach. Our guideline promotes using maternal effort and movement (‘wiggle and push’) as a first-line intervention if advancement pauses for 30 seconds or more at any point after the birth of the pelvis. This optimises maternal agency and minimises the need for attendants to manually intervene. We feel waiting five minutes to assist the birth offers no advantages. Rather, it increases the risk of an adverse outcome should the attendant discover after five minutes that the delay is due to arm or head entrapment, which may take significant time to resolve.

There are limitations to presenting interim data in this way. We cannot assume that the results will continue in the same manner, and a much larger sample size will be needed to determine overall safety. Although local investigators have an obligation to report serious adverse outcomes, currently missing data may reveal in future analyses outcomes that are less positive than they currently appear. These results also do not apply to all planned VBBs. The OptiBreech teams follow a specific care algorithm¹⁰ with manoeuvres specific to upright breech birth³⁷, the presence of an OptiBreech team member increases the likelihood that this will be followed^2,18, and their presence facilitates shared learning from each birth throughout the team. Outside of this model of care, the absence of one or more of these potential mechanisms may impact outcomes.

This analysis has also helped us to identify areas that require further support for cultural change. Our guideline also recommends that, should the baby be born in poor condition, resuscitation be initiated with the umbilical cord intact¹⁶. Current evidence supports leaving the umbilical cord intact until after the onset of respirations^38,39, and service users have identified this in PPIE work as an important and under-studied outcome for them^25,40. However, these data indicate OptiBreech teams are not currently achieving this. Understanding why and developing a strategy for addressing this difficult area of implementation will require further research and collaboration with neonatal teams. While most research has focused on premature babies⁴¹, for whom this practice provides significant benefit, the difference in neonatal admission rates in our data suggest it may be beneficial for term babies as well.

We remind readers that this is an interim data set. Some data points are missing, and in a small data set, results can change dramatically in a short period. However, at this point, we are encouraged by this very positive set of pilot data, which will grow with each trial funded.