The OptiBreech Care Pathway: evaluating the feasibility and acceptability of team care for women seeking to plan a vaginal breech birth (OptiBreech 1) – a mixed methods implementation feasibility study

doi:10.21203/rs.3.rs-2165323/v1

Background

OptiBreech Care is a care pathway for breech presentation at term, including where chosen, physiological breech birth attended by professionals with advanced training and/or proficiency. We aimed to assess the feasibility of implementing OptiBreech team care to test it in trial-within-a-cohort study.

Methods

Our design was a mixed methods trial feasibility assessment across England and Wales, January 2021 – June 2022. Our objectives were to determine whether Trusts could provide attendants with advanced training (implementation feasibility), who deliver protocol-consistent care (fidelity), in a way acceptable to women and staff (acceptability), within existing resources (costs), while maintaining low neonatal admission rates (safety) and adequate recruitment rates (trial feasibility). Participants were women > 37 weeks pregnant with a breech-presenting fetus, requesting support for a vaginal breech birth following standard counselling, and the staff involved in the study. No randomisation occurred in this first stage of feasibility work.

Results

Thirteen National Health Service sites recruited. A total of 82 women planned births on the study, and 21 staff were interviewed. Sites with a breech specialist midwife and/or dedicated clinic recruited 1 woman/month, while sites without recruited an average of 2 women every 3 months. Referrals into the study came from midwives (46%), obstetricians (34%) and women themselves (20%). Vaginal births were attended by staff with OptiBreech training at 87.5% (35/40) and by staff who met stricter proficiency criteria at 67.5% (27/40). Fidelity criteria were met more consistently by staff who met proficiency criteria. There were four neonatal admissions (4.9%, 4/82), including one serious adverse outcome (1.2%, 1/82); these outcomes compare well with previous breech research. Women found the model of care highly acceptable compared to standard care, and staff providing care generally found the OptiBreech model acceptable. However, staffing shortages throughout the pandemic and persistent negative views of vaginal breech birth outside the teams created challenges.

Conclusions

A large prospective observational cohort of OptiBreech Care, which could potentially support nested or cluster randomisation, appears feasible in sites willing to establish a dedicated clinic and develop further proficient members of staff strategically, with back-up plans for supporting rapidly progressing births. Randomisation procedures remain to be feasibility-tested. Funded by the NIHR (300582).

feasibility

implementation

breech presentation

intrapartum care

1) It was uncertain whether staff with enhanced training and experience could be reliably provided for planned physiological breech births (OptiBreech Care).

2) A substantive observational cohort study of OptiBreech Care is feasible. The feasibility of randomising women to OptiBreech Care or standard care within the cohort needs to be tested.

3) The main study is likely to be most successful and efficient in sites with a dedicated clinic supported by a breech specialist midwife and lead obstetrician.

Breech presentation occurs in 4% (1:25) of term pregnancies.(1) A lack of high-quality, recent evidence undermines shared decision-making for women with breech pregnancies, where the baby is positioned head-up instead of head-down. Over 96% of all term breech babies are born by caesarean in the UK,(2) and breech is the indication for 14% of all caesareans in countries with a low perinatal mortality rate.(3) The majority of breech presentations occur in first pregnancies, contributing significantly to the most common indication for surgical delivery: previous caesarean.(3) To reduce the caesarean rate for breech, and associated complications, most women are recommended an attempt at external cephalic version (ECV).(4) An ECV is a procedure to manually turn the fetus head-down using pressure on the maternal abdomen.(4) However, while ECV reduces the caesarean birth rate, it not been shown to improve outcomes for babies, compared to no ECV, in multiple Cochrane Reviews.(5)

The Royal College of Obstetricians and Gynaecologists (RCOG) summary of evidence suggests that with skilled and experienced practitioners, breech birth may be ‘nearly as safe as cephalic [head-down] birth’ (perinatal mortality per 1000: caesarean=0.5, cephalic birth=1, breech birth=2).(1) Yet across the United Kingdom (UK) and internationally, women who wish to plan a vaginal breech birth (VBB) have raised concerns about a lack of support.(6–11)While many women wish to plan a caesarean birth, other women report no option but to deliver by caesarean, causing ‘stress, anger, fear and injustice,'(12) and in some cases long-term emotional trauma.(13) Some feel pressured to attempt an ECV,(14–16) and some experience the procedure as very painful, with over 10% describing it as ‘intolerable.’(17)

As many as 35-58% of women may prefer to plan a VBB, but this is highly dependent on the type of counselling they receive.(18,19) Some hospitals have created breech clinics and/or an on-call team to revive breech skills,(20,21) and these attract women who lack local support.(22,23)The VBB rate can rise as high as 6-11% of the total birth rate due to women travelling to experienced providers,(22,23) compared to 0.4% of the total birth rate in the UK.(2) When one hospital in Belgium implemented specialist team care for physiological breech births, this resulted in a statistically significant increase in vaginal breech births (4.3% to 43.5%), together with a non-statistically significant decrease in neonatal admissions.(24)

Physiological breech birth is an approach to managing VBBs based on evidence about the normal physiology of breech labour and birth and how this is optimised.(25–28) These methods include guidance on indications for intervention based on video and clinical records analysis,(26,27) and use of upright active maternal birth positions. Louwen et alreported on 229 upright breech births compared to supine deliveries. Upright births were associated with significantly fewer manoeuvres (manual interventions, including forceps) (OR 0.45, 95% CI 0.31-0.68) and neonatal birth injuries (OR 0.08, 95% CI 0.01-0.58).(22) Second stages of labour were 42% shorter, with a non-significant decrease in serious perineal lacerations. Rates of caesarean in labour also decreased following the implementation of upright breech birth. In Bogner et al’s smaller study of 41 matched pairs, upright breech births were associated with a reduction in severe perineal injury from 58.5% to 14.6%, and 70% of all births took place spontaneously, without the need for manoeuvres.(29)

Experienced team care, upright maternal positioning and time-based indications for manual assistance are significant departures from methods of breech delivery that have been used in the United Kingdom (UK) National Health Service (NHS) and tested in previous trials.(30) Such substantive differences are likely to impact outcomes. To begin to evaluate this impact, we began by developing a complex intervention that could be tested in a trial (NIHR300582).

Proposed intervention

The OptiBreech Care Pathway is a proposed innovation package based on programme theory developed from previous research, briefly summarised as follows:

Providing reliable, experienced support for physiological breech births, in which women are encouraged to remain active and adopt the birthing position of their choice (the intervention), will improve access to and outcomes of breech births
because this is more acceptable to women than standard care,⁴ in which skill levels are unpredictably variable and low overall(31,32) (mechanism 1);
and because birthing in upright positions results in shorter labours and fewer interventions, compared to the supine birthing positions prescribed in standard care(25) (mechanism 2);
but these potential benefits may only be realised in contexts where specialist multi-disciplinary teams are enabled to self-organise to support the wider maternity care team as required(33) (context).

Programme theory is summarised in a logic model. Figure 1 presents the original OptiBreech logic model. Figure 2 presents the current OptiBreech logic model, refined through this early implementation feasibility assessment.

Aims and objectives

Our original aim was to pilot a trial within cohort (TWiC) design(34,35) to evaluate the outcomes of OptiBreech Care compared with standard care. However, potential sites expressed doubt that they would be able to implement the teams required to deliver OptiBreech Care. This included the original NHS co-sponsor of the study, who withdrew from participation at the start of the COVID-19 pandemic (summer 2020). Following discussion with sites about their concerns, it was collaboratively decided with them that a first-stage observational study and implementation process evaluation would help determine whether proceeding to a randomised pilot TWiC would be feasible.

The overall aim of this study (OptiBreech 1) was to assess the feasibility of implementing OptiBreech team care so that it could be tested in large trial-within-a-cohort study. Our objectives were to determine whether Trusts could provide attendants with advanced training (implementation feasibility), who deliver protocol-consistent care (fidelity), in a way acceptable to women and staff (acceptability), within existing resources (costs), while maintaining low neonatal admission rates (safety) and adequate recruitment rates (trial feasibility).

Study design

The OptiBreech 1 study used a mixed-methods design to evaluate the process of implementing proficient team care for vaginal breech births. The purpose of a process evaluation to inform trials of a complex interventions is to understand the effects of implementing a new intervention and the mechanisms of these effects in new contexts.(36,37) A detailed implementation process evaluation within a feasibility study increases the chances of a successful trial.(38) Implementation outcomes were informed by Proctor et al and focused on feasibility, fidelity, acceptability, and costs.(39)

Patient and Public Involvement and Engagement

The OptiBreech Patient and Public Involvement and Engagement (PPIE) Group is composed of women who have planned a VBB, either within the study or outside of it, and service user representatives who work with this population. We held one face-to-face PPIE meeting during the design phase of the study, including consent procedures,(40) and four PPIE meetings during the study via Microsoft Teams. Participants also requested a closed FaceBook OptiBreech PPIE group, and this was created.

During each of the PPIE meetings, participants raised concerns about the difficulties they experienced accessing support for VBB, and this included finding information about how to access OptiBreech Care through participation in the study. Participants asked the research team to promote the study more on social media and by contacting maternity services in locations surrounding the OptiBreech sites, and this was done.

We also involved two women with experience of planning a breech birth as co-researchers. In addition to influencing the design of the research, they were particularly involved in helping to interpret results from qualitative interviews with women. Another service user representative served on the Study Steering Committee (SSC). These women’s experiences included uncomplicated birth, complicated birth including neonatal death and in-labour caesarean with postnatal complications.

Oversight: Study Steering Committee

As this was an observational study, an SSC was appointed. The SSC was chaired by a Professor of Midwifery and included two independent obstetric representatives with experience of clinical trials and breech research. Members of the research team were also included on the SSC, along with the service user representative. The primary purpose of the SSC was to monitor the progress of the study and conduct and advise on its scientific credibility. Four meetings were held. These included a review of a Serious Adverse Event and subsequent protocol changes (August 2021), the decision to proceed to the pilot of randomisation within the four leading sites (November 2021), and early closure of the OptiBreech 1 study (June 2021). A final meeting was held in September 2022 to affirm the plan for a larger prospective observational study (n=365) as the next stage in the OptiBreech research.

Participants

Recruitment occurred between February 2021 and June 2022, with follow up until August 2022.

Women and pregnant people

Inclusion criteria for OptiBreech 1 included:

Singleton pregnancy > 37⁺⁰ weeks with a breech-presenting fetus confirmed by ultrasound scan (for counselling);
Eligible for approach and recruitment from 36⁺⁰;
Referred by obstetric consultant, midwife or self (from a different hospital);
Requesting a vaginal breech birth under current Trust guideline;
Giving informed consent to participate in outcome monitoring as part of the study.

Exclusion criteria included:

Absolute contraindication to vaginal birth, such as placenta praevia
Multiple gestation (twins, triplets, etc.)
The proficient team declines to offer care because the clinical case is outside the team’s local guideline or experience level (at the discretion of the Breech Leads)
Declines consent to participate in research;
Other exclusion criteria may apply depending on the Trust's breech presentation guideline.

Participants who expressed an intention to plan a breech birth under the participating Trust’s current guideline were referred to the local Principal Investigator (PI) and provided information about the study. All participants were informed that sites were attempting to implement team care to support breech births but that this could not be absolutely guaranteed. Written consent was obtained, using either in-person or e-consent procedures.

Contact information for PIs was also available on the study’s website.(41) Participants who self-referred onto the study from other hospitals did so by contacting one of the PIs or the Chief Investigator for referral to their nearest OptiBreech site. Where breech presentations were diagnosed in labour, and the attending clinicians called an OptiBreech team member for support, consent to contribute data to the study was sought after the birth rather than during labour, in keeping with current RCOG guidance on “Obtaining Valid Consent to Participate in Perinatal Research Where Consent is Time Critical”(42). Women who were asked for consent were also able to discuss their birth experience with members of their care team, as recommended by our PPIE group.

No sample size was set for VBBs. The sample size for qualitative interviews was designed to enable maximum variation sampling, a variety of experiences across multiple sites. Formal interviews conducted with women and the methods for their analysis have been reported separately.(43) Some quantitative results have been previously reported to contextualise the qualitative findings.

Staff

Thirteen NHS hospitals in England and Wales participated. Sites included:

Birmingham Women’s Hospital

Chelsea and Westminster Hospital, London

Kingston Hospital, London

Imperial College London, Queen Charlotte’s and Chelsea Hospital

Lewisham Hospital, London

Liverpool Women’s Hospital

Musgrove Park Hospital, Somerset

Prince Charles Hospital, Merthyr Tydfil, Wales

Royal Cornwall Hospital

Royal Oldham Hospital, Manchester

Royal Sussex County Hospital, Brighton

Surrey and Sussex Hospital, Redhill

West Middlesex Hospital, London

To identify staff willing to participate in the study, at the start of the study staff working in intrapartum settings were invited to complete an Interest and Proficiency Survey, which included consent for an interview and/or questions about their experience and confidence levels.

Each site was requested to identify a Breech Lead Obstetrician and a Breech Lead Midwife, one of whom was the PI. The leads were responsible for maintaining records of who had completed OptiBreech training and/or met proficiency criteria to plan intrapartum care. The protocol suggested appointing a ‘breech team’ of five obstetricians and five midwives, and funding was set aside to support their training. However, the research team did not specify the exact arrangements and instead aimed to observe the process individual sites adopted to meet the needs of the service in their contexts.

To support teams through this process, monthly OptiBreech meetings were held. These began with a focus on an aspect of clinical care and ended with an opportunity for reflection and support. Unless identified as formal interview data, ‘discussions’ described below refer to these numerous and informal discussions that took place throughout the study as the research team sought to understand how all of the study processes were working. Formal interviews conducted with participating staff, and the methods for their analysis, will be reported separately.

Intervention

The aim of the study was to observe if sites were able to implement OptiBreech-trained and/or proficient team care for physiological breech births. The target was 90% of births attended by someone who had completed OptiBreech training.

OptiBreech physiological breech birth training was provided free to participating Trusts by Breech Birth Network, CIC. The training programme had previously been fully evaluated within NHS Trusts.(44) However, during the COVID-19 pandemic, it became difficult to release staff for in-person training. The entire training package was moved on-line and supplemented with hands-on skills training delivered by leads whenever possible. The proficiency criteria were based on previous research concerning Standards for maternity care professionals attending planned upright breech births,(31) Deliberate acquisition of competence in upright breech birth(45) and Expertise in physiological breech birth(33). These are defined in Figure 3: Proficiency Criteria.

To support implementation of the OptiBreech training all team members should have undertaken, a copy of the Physiological Breech Birth Algorithm(27) and a pro forma for documenting critical information around the time of birth were provided. Later, following review of a serious adverse outcome by the SSC, an algorithm to guide decision-making in the second stage of labour was also provided.

Outcomes

The implementation outcomes assessed were:

Trial feasibility – Assessed through observational data reported on the Case Report Form (CRF), recruitment and retention figures, PI and research site recruitment. Do the recruitment processes result in a sufficient number of women and research sites recruited to support a fully powered substantive study?
Intervention feasibility – Assessed through observational data reported on the CRF, attendance by OptiBreech-trained and/or proficient team members. Is it feasible to implement OptiBreech team care so that it can be tested in a substantive study? The feasibility target was 90% attendance by a member of the team with OptiBreech training. Staff background experience and confidence levels were also evaluated via survey.
Fidelity – Assessed through observational data reported on the CRF, as below. Is care provided consistently according to the core principles of physiological breech birth?
Acceptability – Assessed qualitatively through interviews with women and staff. Detailed qualitative reports on this outcome will be published separately from this overall report of the study. Are women who wish to plan a vaginal breech birth satisfied with the model of care we are testing?(43) Do staff providing this model of care find it acceptable to deliver?
Costs – Secondary outcome, assessed through observational data, time spent on-call to deliver service, estimated time spent attending each VBB, and time spent completing OptiBreech training. How much does it cost to develop a fully proficient breech team member?

The service outcomes assessed were:

Safety – Assessed through observational data, neonatal admission rates immediately following birth and neonatal deaths up to 28 days. Is there any indication of increased neonatal risk in OptiBreech Care, compared to planned VBB in standard care?
Effectiveness – Secondary outcome, assessed through observational data, mode of birth rates, including rates of breech presentation diagnosed in labour, attempt at external cephalic version prior to planned VBB and reasons for caesarean birth. Do the mode of birth outcomes suggest a substantive trial would provide valuable clinical effectiveness information?

The following physiological VBB fidelity criteria were pre-specified. All are included in the Physiological Breech Birth Algorithm.

Maternal birth position: We monitored maternal birth positions (upright or supine) to ensure that women were being provided with this option. Upright birthing position is considered a ‘tool and not a rule’ of physiological VBB.(25)

Maternal movement and effort: After the breech remains visible on the perineum between contractions, following any delay >90 seconds, the clinician should encourage maternal movement (if upright) and effort (pushing). Hands-on interventions should be applied only after this is ineffective. A core principle of physiological breech birth is that the mother-baby unit is the locus of greatest power and efficacy.(25) In simple terms, this means attendants encourage women to ‘wiggle and push’ as a way of encouraging continuous progress once the pelvis has been born, and to assess the presence of obstruction, prior to hands-on assistance.

Pelvis-to-head interval: The fetal head should be delivered no longer than 5 minutes after the pelvis is born. This includes time to perform manoeuvres. Our original study of birth videos indicated that the median time between birth of the pelvis and birth of the head in upright births was 01:52, and >75% of these births were complete within 3 minutes. We also tested this in a case-control study.(46) Therefore, 5 minutes was considered to be an adequate window to expect a birth without complications to be complete, including time for interventions.

The following criteria were added in January 2022, in response to the SAE and verbal reports that sites were not following the Algorithm guidance about optimal cord management at birth.

Rumping-to-head interval: The fetal head should be delivered no longer than 7 minutes after the anus and both buttocks are visible on the perineum between contractions (rumping, +3 station). This includes time to perform manoeuvres.

Optimal cord management: In accordance with NICE(47) guidelines and the Algorithm, the umbilical cord must remain intact for a minimum of 1 minute UNLESS there are concerns about cord integrity or the neonatal heartrate has been assessed with a stethoscope as less than 60 bpm and not improving with stimulation and/or resuscitation measures with the umbilical cord attached.

Pre-specified fidelity targets were not set. Instead, the goal was to investigate cases which did not meet criteria and understand why through formal interviews and informal discussions with PIs.

Changes to study design

An important change to the study design occurred during the set-up phase. Our original implementation feasibility objective was to determine only how often births were attended by someone who met the full proficiency criteria, with a 90% target. However, several sites indicated that this would be difficult or impossible, due to the low overall experience levels they began with. We concluded that, if OptiBreech Care were tested in a substantive study or scaled up after a positive trial, many sites would need to pass through a period of building up capacity to meet the ‘proficient attendant’ criteria. Therefore, we decided to set a realistic target for the sites who needed to develop proficient attendants. The revised criteria was ‘attendance by someone who had completed the enhanced OptiBreech training,’ with a 90% target. We continued to also assess the rate of attendance by someone meeting the full criteria.

Additionally, one of the objectives stated in our protocol was to assess how much time it takes to develop a proficient team to deliver the service. Assessing this in terms of ‘time’ was an ineffective approach, affected by too many variables, including staffing levels during the COVID-19 pandemic and baseline PBB rates within the individual setting. A more useful approach, based on a key implementation outcome,(39) is to assess this based on cost. The cost of developing a proficient team member was possible to assess based on the data we collected in this study, including amount of time spent on-call to support the births. We have therefore added ‘costs’ above as a secondary objective. Rather than reporting ‘time’ to develop proficient team members, as per our original objective, we report the ‘cost’ of the time needed to develop the team and deliver the service. Properly costing this time will support replication of the activities delivered in sites that have successfully implemented OptiBreech Care.

A final change included early closure of the study. OptiBreech 1 was originally scheduled to run until 31 August 2023. In April 2022, the NIHR went through a process of clearing the portfolio of studies following COVID-19, during which many research studies stagnated, with poor recruitment. At this point, the OptiBreech 1 study had over-recruited from our initial target of 40, with 82 women and 21 staff having participated in the study already. At a special meeting of the Study Steering Committee (SSC), it was decided that sufficient recruitment had been achieved to decide on feasibility of a substantive observational cohort. The OptiBreech 1 study was closed to recruitment in June 2022, and sites remaining open at that time were invited to contribute to the cohort arm of the OptiBreech Care Trial.

Below we present the results according to the list of implementation outcomes, alongside a brief discussion of the implication of these results.

1. Trial feasibility

Recruitment

From January 2021, sites 100-102 were selected to proceed to the OptiBreech Care Trial randomisation pilot; these sites then stopped recruiting to OptiBreech 1. These are reported as ‘pilot trial sites’ below, and the recruitment figures reflect only their recruitment to OptiBreech 1.

Table 1: Recruitment figures and site characteristics

Code	Total recruitment	Months open	Average per month	Dedicated clinic?	Face-to-face training? *	Breech specialist midwife?	Other notes
100-A	12	8	1.5	Yes	BSM	Formal
100-B	8	8	1	Yes	BSM	Formal
101	14	12	1.2	No	BSM	Formal	++ self-referral transfers
102	6	8	0.8	Yes	Study team	Formal
Total recruited in pilot trial sites (A)	40	36	1.1
Changed mind (planned CB-A)	4
Pilot trial sites net	36	36	1
103	9	11	0.8	No	Study team	Informal
105	8	12	0.7	No	BSM	Informal
106	3	10	0.3	No	Previous	No
107	5	15	0.3	No	No	No
108	6	11	0.5	No	No	Informal	Obstetric PI
115	4	5	0.8	No	Previous	No	Site closed – unable to release staff for training / team
119	1	4	0.3	No	No	No	Site closed following adverse outcome, pending FTF training
120	3	9	0.3	No	No	No	Obstetric PI, Site closed following adverse outcome, pending FTF training
128	3	4	0.75	No	No	Informal	Obstetric PI
Total recruited in remaining sites (B)	42
Changed mind (planned CB-B)	5
Total recruited across the study (A+B)	82	109	.75
Total changed mind (planned CB A+B)	9
Net total	73	109	.67

* BSM: Hands-on training was facilitated by internal breech specialist midwife. Study team: A separate study day was provided by the research team. Previous: Some sites had hosted physiological breech birth training days prior to the start of the study and had staff members who had historically completed the enhanced training.

Based on these recruitment data, to achieve optimal recruitment of at least one woman per month who continues with a plan for a VBB, sites will need to be supported to host a dedicated clinic and breech specialist midwife able to disseminate training within the sites.

Qualitative data provided insight into observed differences in recruitment at centres with clinics and/or specialist midwives.(43,48) In interviews and informal contacts, women reported numerous incidences of imbalanced counselling in favour of caesarean birth as the only reasonable option from obstetricians, except for those involved in the study. They reported some instances of imbalanced counselling in favour of VBB as a low-risk option from midwives, except for those involved in the study. In interviews, they contrasted this with counselling received in clinics and from specialist midwives or obstetricians working in dedicated clinics, which presented risks as well as benefits of all options. Women reported specialists consistently recommended a multi-disciplinary approach in a multi-disciplinary setting, eg. hospital obstetric units. Women also reported increased confidence to plan a VBB when they had a reasonably good chance of an experienced attendant, which they felt the OptiBreech care pathway provided them.(43,48)

Staff shortages during the COVID-19 pandemic influenced recruitment figures. For example, Sites 100A and 100B were not able to receive self-referrals throughout their participation on this study, despite multiple requests from women who wanted to transfer their care to an OptiBreech site to participate in the research. Managers based this decision on staffing levels and the perceived ‘difficulty of keeping any birth safe’ (informal discussions) in these conditions. Staffing shortages are unlikely to improve significantly in the short term; they may continue to impact capacity of sites to release staff for training or to meet the demand for vaginal breech birth support.

Non-recruiting or non-opening sites

The original plan was to include 4-5 sites in a pilot trial. The OptiBreech 1 study as a pre-cursor to the pilot trial came about as a response to sites’ concerns that they could not randomise women to OptiBreech Care, as they were not sure it was feasible to provide it in the first place. During the COVID-19 pandemic, it was clear that delivering clinical research would require extraordinary effort from those leading the study locally. The research team therefore welcomed all sites that expressed an interest in trying, and 29 sites were included on the protocol. This also enabled the research team to observe site-specific conditions that resulted in more efficient site opening, higher recruitment figures, higher achievement of proficient attendants, better feedback from women using the service, etc., to inform future site-selection strategy.

Three sites opened but did not recruit to the study. The CI formally wrote to each site and asked PIs and Research and Development (R&D) Departments to provide their views on why recruitment did not occur. One of these sites was not able to support planned VBBs on the study due to reported ‘strong resistance from the obstetric clinical lead’ and other members of the obstetric team, despite having an obstetric PI and members of the senior midwifery team committed to being on-call for the births. Another site has a dedicated breech clinic staffed by an obstetrician who completed the training and regularly attends breech births, but there was initially no breech lead midwife with capacity to conduct the necessary research activities. The R&D Department was also severely short-staffed, delaying confirmation of capability and capacity for over a year, until just before the OptiBreech 1 study closed. The third did not provide a reason.

Three sites opened and then closed. One of them reported being unable to release staff for training or to be on-call for breech births, due to severe staff shortages. The other two experienced an adverse outcome that may have been associated in part with protocol violations; following discussion with the SSC, the sites were requested to pause recruitment until further in-person training could be provided to the team. Pandemic conditions prevented this being organised until after the study closed. Key team members at one of the sites have now completed this training, and the site has rejoined the observational arm of the OptiBreech Care Trial.

Thirteen sites listed on our IRAS submission did not open at all. Among those who responded, the reasons provided were as follows:

Insufficient capacity within the R&D Department to open the study (4) – including clinical teams not being able to release research midwives on secondment
Objections from obstetric or midwifery leadership to participation in the study (4)
Unable to release staff for training (4)

Staffing issues prevented enabling people to be on-call for breech births (4)
Insufficient workforce capacity within clinical team to deliver the study (4) – including no PI

A total of three Band 8 midwives reported unprompted that they left clinical work at the Trust where they were based, in part due to resistance from the obstetric leadership, which prevented the study from opening or breech births from happening without conflict once the study had opened.

Building research capacity building

Table 2: Principal Investigators

Profession of PI	Total 29	Opened & recruited	Study site did not open / did not recruit / withdrawn
Midwife	19*	10	10*
Obstetrician	9	3	6
Not named	1	n/a	1

* One site did open and recruit, then withdrew. Some Trusts had multiple sites but only one official PI listed on the IRAS form.

The final protocol listed 29 potential sites who had expressed an interest in joining the study. However, only 12 sites (13 hospitals) opened and recruited to the study. Ten of these sites were led by midwife PIs. Interactions with R&D offices indicated this was unusual, with some questioning whether it was possible for a midwife to be a PI on a research study, believing it was a requirement to have an obstetric PI. However, the research team took the view that the person leading the study and taking responsibility for the research activities should be named and recognised as the PI. Enabling midwife PIs has been central to our ability to deliver this research. Unfortunately, not all midwives nor obstetricians who were willing to take responsibility for leading the research were supported locally to do so.

All PIs in the sites that opened and remained open were also PIs for the first time. This involved an investment in time and capacity-building, requiring extra support from the central research team. Most of these PIs are continuing as PIs in the OptiBreech Care Trial, the next stage in this research. Some have gone on to become PIs in additional studies, and one is in the process of applying for a fellowship to progress her own career in research. Many of the PIs also took responsibility for attending births on the study to support the team members to develop, or to support members of the regular clinical team. Discussions with PIs indicated this may be more challenging for obstetric staff, whereas midwifery staff often worked more flexibly, including through on-call arrangements.

This research concerned an area of clinical practice that all PIs expressed commitment to improving, in formal interviews and informal discussions. Vaginal breech birth has been a problematic and conflicted area of practice for some time,(11) and they described being keen to help find a solution. This appeared to be what motivated clinical midwives and obstetricians to become involved in leading and delivering research for the first time. Not all were successful in their attempts. Interviews and information conversations indicated that dealing with resistance and conflict took a toll on several potential and actual PIs, due to frustrations at being blocked in their attempts to deliver the standard of care they wished to provide for women.(49,50)

One PI also stepped down from the role following a severe adverse outcome, which also had a negative effect on this person’s well-being, as it did for the family involved. Future research should consider additional time required to achieve successful cultural change, and to support staff leading the service/research or affected by severe adverse outcomes. Despite the best efforts of clinical staff, severe adverse outcomes are occasionally unavoidable, regardless of the way people choose to give birth to their breech babies. When introducing new practices in an area already known to be at higher risk, adverse outcomes are likely to occur, and appropriate support should be available.

2. Intervention feasibility

Background experience and confidence

Completion of the Interest and Proficiency Survey was variable among sites. The original intention was to repeat the survey at the end of the study. However, as most sites did not adopt the identified team model as suggested, and some members of teams chose not to complete the survey, this would not have been meaningful. Nonetheless, the results provide a snapshot of experience and confidence levels among a cross-section of self-selecting professionals who have an interest in supporting VBBs.

A total of 97 responses were received, across all thirteen sites. Only 4/97 (4%) of respondents met all proficiency criteria as defined above. In general, mean levels of experience were greater than medians. This is likely the result of deliberate acquisition of experience due to the special interest of some professionals, as described in previous research.(45)

Table 3: Roles and numbers of vaginal breech births attended

Role	Responses	Total	Median	Mean	Minimum	Maximum	Std Dev
Consultant obstetrician	7	205	30	29.29	10	50	15.924
Obstetric Registrar	4	32	7.5	8.00	2	15	5.715
Consultant Midwife / Band 8	5	55	10	11.00	5	20	5.657
Senior Midwife / Band 7	25	222	5	8.88	1	40	10.252
Staff Midwife / Band 6	50	144	2	2.88	0	10	2.840
Preceptorship Midwife / Band 5	3	2	0	.67	0	2	1.155
Student Midwife	3	0	0	0	0	0	0
Total	97	660	3	6.80	0	50	9.911

Table 4: Roles and numbers of breech births attended within the past year

Role	Responses	Total	Median	Mean	Minimum	Maximum	Std Dev
Consultant obstetrician	7	20	2	2.86	0	10	3.671
Obstetric Registrar	4	3	0.5	.75	0	2	.957
Consultant Midwife / Band 8	5	6	1	1.20	1	2	.447
Senior Midwife / Band 7	25	29	1	1.16	0	4	1.214
Staff Midwife / Band 6	50	38	0	.76	0	4	1.041
Preceptorship Midwife / Band 5	3	0	0	0	0	0	0
Student Midwife	3	0	0	0	0	0	0
Total	97	96	1	.99	0	10	1.468

Table 5: Training and overall confidence

n (%)	Have you delivered breech training or a reflective review of a breech birth within the past year?		Have you completed at least 6 hours of physiological breech birth training, in person or on-line?		Do you feel confident to attend vaginal breech births as the lead care provider? *
Role	Yes	No	Yes	No	Yes	No
Consultant obstetrician	4 (57)	3 (43)	3 (43)	4 (57)	7 (100)	0
Obstetric Registrar	1 (25)	3 (75)	25 (1)	3 (75)	2 (50)	2 (50)
Consultant Midwife / Band 8	5 (100)	0	4 (80)	1 (20)	4 (80)	1 (20)
Senior Midwife / Band 7	10 (40)	15 (60)	20 (80)	5 (20)	20 (80)	5 (20)
Staff Midwife / Band 6	8 (16)	42 (84)	32 (64)	18 (36)	23 (46)	27 (54)
Preceptorship Midwife / Band 5	0	3 (100)	1 (33)	2 (67)	1 (33)	2 (67)
Student Midwife	0	3 (100)	0	3 (100)	0	3
Total	28 (29)	69 (71)	61 (63)	36 (37)	57 (59)	40 (41)

*(Note: this assumes you are not alone and can escalate for more support. But as the lead care provider, you are clinically responsible for guiding the birth.)

Table 6: Confidence with upright birthing positions

n (%)	Do you feel comfortable enabling women to give birth to a breech baby in the position of their choice, including upright (e.g. kneeling, hands/knees, standing, birthing stool)?
Role	Yes, and I am experienced attending upright breech births	Yes, but I have minimal experience attending upright breech births so would prefer to convert to supine if interventions are required	No, I prefer women to birth in a supine position
Consultant obstetrician	1 (14)	6 (86)	0
Obstetric Registrar	0	14 (100)	0
Consultant Midwife / Band 8	5 (100)	0	0
Senior Midwife / Band 7	12 (48)	12 (48)	1 (4)
Staff Midwife / Band 6	18 (36)	31 (62)	1 (2)
Preceptorship Midwife / Band 5	1 (33)	2 (67)	0
Student Midwife	0	2 (67)	1 (33)
Total	37 (38)	57 (59)	3 (3)

Table 7: Confidence with resolving complications

Do you feel confident in your ability to … (tick all that apply) n (%)	Yes, and I have done this previously	Yes, and I have taught this to others	Yes, and I have done this in simulation	Not yet
Deliver an aftercoming head that is caught at the inlet to the pelvis?	15 (16)	10 (10)	45 (46)	49 (51)
Deliver an aftercoming head that is caught in the pelvic outlet?	18 (19)	12 (12)	46 (47)	46 (47)
Release a nuchal arm trapped above the pelvic inlet with rotational manoeuvres?	12 (12)	15 (16)	64 (66)	26 (27)
Release an arm caught mid-pelvis or in the pelvic outlet?	15 (16)	14 (14)	57 (59)	32 (33)
Deliver the aftercoming head using forceps? (obstetricians only, n=11)	7 (64)	4 (36)	3 (27)	2 (18)

OptiBreech-trained attendants

Our goal was to achieve 90% of vaginal births attended by a professional who had completed enhanced OptiBreech training, regardless of their experience level attending live breech births or managing complications in real time. We achieved 87.5% (35/40). One of the cases involving no attendant with enhanced training was a precipitous birth occurring at the woman’s home with no one in attendance, and one involved a rapidly progressing birth where the OptiBreech attendant was called but did not arrive in time for the birth. In another rapidly progressing birth, where the woman arrived at hospital fully dilated, a proficient OptiBreech attendant was present, but only for the last 20 minutes of the birth, rather than all of 2^nd stage as per the protocol.

The other two cases occurred at sites where ‘upright breech’ had been fully incorporated into mandatory training for some time. In one, no OptiBreech trained attendant was called because the consultant obstetrician felt confident with upright breech birth and facilitated the birth. At the other, no attempt was made to call someone with enhanced training, but the birth was managed by a midwife who felt confident with upright breech birth. Following discussion with the PI, the decision was made that the site did not have capacity to release staff for training. They therefore did not feel it was feasible to attempt to achieve this and withdrew from the study. The root causes in these two cases are modifiable.

Although the pre-specified 90% target was not reached, following discussion with the Steering Committee, it was decided that in 3/5 cases this was out of anyone’s control due to the unpredictable nature of birth, rather than unavailability of trained attendents or non-compliance. Rather than preventing a substantive study, this should be subject to further monitoring and informed consent. The results indicate that, for various reasons, approximately 12.5% of planned OptiBreech births may not be attended by fully OptiBreech-trained attendants. Any future studies should ensure women are informed of this possibility. The research team should work with sites to ensure the protocol is followed with fidelity, but this should also include ‘safety-netting’ with a mini update for staff attending VBBs where an OptiBreech team member is not present.

Fully proficient attendants

This criterion was more difficult to achieve, and 27/40 (67.5%) was achieved. No attendants attended enough births to gain ‘proficiency’ during the study, although one of the lead recruiting sites came very near to achieving this. Where this criterion was met it was due to attendants (midwives or obstetricians) who were already fully proficient working flexibly (on-call) to attend the births and support other staff to acquire experience.(43)

Although the study was not powered to detect statistically significant differences, in all fidelity categories, greater fidelity to the protocol was observed with trained and/or proficient attendants at the birth (Table 8: Fidelity criteria).

3. Fidelity to physiological breech birth practice

Table 8: Fidelity criteria

	Attendant with OptiBreech training	None present with OptiBreech training	Attendant who met proficiency criteria	No one present meeting proficiency criteria	Total sample (%)
Maternal birth position
upright	28 (80)	2 (50)	22 (81.5)	8 (66.7)	30 (76.9)
supine	7 (20)	2 (50)	5 (18.5)	4 (33.3)	9 (23.0)
Encouraged movement & effort
none required	6 (17.1)	1 (25.0)	5 (18.5)	2 (16.7)	7 (17.9)
yes	25 (71.4)	2 (50.0)	21 (77.8)	6 (50.0)	27 (67.5)
no	4 (11.4)	1 (25.0)	1 (3.7)	4 (33.3)	5 (12.5)
<5 minutes pelvis-to-birth
yes	31 (88.6)	3 (75.0)	24 (88.9)	10 (83.3)	34 (87.2)
no	4 (11.4)	1 (25.0)	3 (11.1)	2 (16.7)	5 (12.8)
TOTAL	35/39 (89.7)	4/39 (10.2)	27/39 (69.2)	12/39 (30.7)	39*

* BBA/unassisted birth excluded. Where encouragement of movement and effort was not required, it meant that the birth occurred spontaneously, without direction from the attendant and without hands-on assistance.

Maternal birth position

When women were attended by professionals who had not completed enhanced training, they used upright positions approximately 50% of the time. In each case, these professionals had exposure to the techniques through their annual mandatory training activities. When professionals had enhanced training and/or proficiency, this figure rose to 80% and 81.5% and above. The finding that upright positioning was used increasingly following OptiBreech training and proficiency accords with previous physiological breech birth training evaluation data, in which this figure was also 80% following training.(44) Where professionals receive adequate training, both women and professionals appear to find upright birth positioning in vaginal breech births acceptable, and some prefer it.

Maternal movement and effort

In approximately 1 in 5 births, neither verbal nor manual intervention was required for the birth to occur within the recommended time frame with good neonatal outcomes. Among proficient attendants, maternal movement and effort was used prior to hands-on assistance in 95% of cases. Among attendants who had completed OptiBreech training, fidelity to this criterion was 86%, and where no attendant completing OptiBreech training was present, it was 66%.

Pelvis-to-birth interval <5 minutes

This criterion was met 88.6% and 88.9% of the time by OptiBreech-training and proficient attendants, respectively, and 75% in births where neither were present. The research team explored each case of not meeting the ‘<5 minutes from pelvis born to birth’ criteria very carefully to determine whether further support could improve this.

Rumping-to-birth interval <7 minutes

In March 2022, ‘rumping-to-birth interval <7 minutes’ was added as a fidelity criteria due to the SAE and publication of research that indicating this interval may be more important than the pelvis-to-birth interval.(26) Because of the short interval between beginning to collect this information and the close of OptiBreech 1 (March 2022 – June 2022), we only collected data on eight births. This interval was only exceeded in one of them, which was the only neonatal admission in this group. In this birth, the legs were assisted one minute after the birth of the pelvis, but the arms were not born for another three minutes and are recorded as born spontaneously, assistance ‘not needed.’ Assistance to deliver the head was initiated at five minutes after the pelvis was born, and the process took four minutes.

Resuscitation with umbilical cord intact

In March 2022, ‘initiation of resuscitation with the umbilical cord intact’ was also added as one of the fidelity criteria, due to feedback from our PPIE group(51) and anecdotal reports from staff that this aspect of the training was not being achieved in practice. We were able to collect data on eight instances of resuscitation measures following vaginal breech births. Among babies where neonatal admissions did not occur, three received resuscitative measures, but the team did not achieve stabilisation on the cord. In each of these instances, occurring in hospital settings, the OptiBreech team member felt resuscitation was not required, but other members of the team requested that the cord be clamped and cut so that the baby could be examined on the resuscitaire. In one instance, the fetal heart was confirmed as over 60 and improving, but the paediatric team preferred to examine the baby on the resuscitaire, so the umbilicus was clamped and cut prior to stabilisation, outside of guidance and the study protocol.

In each of these occurrences, OptiBreech team members felt that pressure from other members of the team contributed to inability to achieve this recommendation, as well as the physical environment, in which bedside resuscitation units are not standard and instead are attached to the wall or are too large to fit into the delivery rooms. One site does have a bedside stabilisation/resus unit, but it is ‘owned’ by the neonatal team and not able to be used outside of theatre for term babies.

In the two other instances which did not involve neonatal admissions, despite 1-minute Apgar scores <4, resuscitation was initiated with the cord intact, and the cord was not severed until after the onset of respirations. In one case, the environment was a home birth, where resuscitation stations are set up on the floor beside the birthing person as a matter of necessity. The other took place in the single participating site in which bedside resuscitation units are used as standard.

In the three instances associated with neonatal admission, the cord was clamped and cut immediately. There is no record that the fetal heartrate was assessed prior to taking this action. Further implementation work is needed to be done to ensure fidelity to this aspect of the protocol.

4. Acceptability

Analysis of the qualitative interviews regarding the acceptability of OptiBreech Care are reported separately so that the findings can be discussed in depth.(43) Source of referral (Table 9) is a quantitative source of data that relates to the acceptability of OptiBreech Care among multiple stakeholders: midwives, obstetricians and care recipients (Figure 4: Flow Diagram).

Source of referral

Table 9: Sources of referral

Midwife	38/82	46.3%
Obstetrician	28/82	34.1%
Self	16/82	19.5%

Referral and interview data indicate that many midwives and obstetricians in participating sites were engaged with this research, providing referrals and some attending births. Unfortunately, support was not universal. Two of the three obstetric consultants interviewed reported strong resistance from their colleagues to the idea of supporting VBBs in general or to the new methods.

During the study period, the CI personally received over 30 direct e-mail requests and phone calls from women pregnant at term with a breech baby, asking for support and guidance, because they could not access this at their local booking hospital. Another PI who also has a public teaching profile, also received numerous direct e-mails. Not all of these were able to be accommodated on the study, due to sever staffing shortages throughout the pandemic, or geographic distance.

Nearly 20% of women participating on this study referred themselves and transferred their care from a different hospital to access OptiBreech Care. This suggests that sufficient demand exists to support a larger study, and that the proposed care pathway is meeting a need that is not consistently met within current NHS services. However, sites reported difficulty facilitating transfers of care due to staff shortages. This conflicts with the ethical imperative of enabling access to publicly-funded research and may affect ability to meet recruitment potential. Future research may need to ensure participating sites receive the support they need to accept women transferring to access specialist care, as would occur if the model were scaled up.

5. Costs

Time spent on-call

Within the first two months of study opening, when the research team became aware that breech lead midwives were putting themselves on-call to attend VBBs, the protocol was amended to enable us to collect information about days and nights spent on-call. This varied considerably. It was impacted by the quantity of planned VBBs being supported, as PIs were instructed to report 1 day or night of on-call time on only one CRF, and specialists in higher recruiting sites were often on-call for multiple births at once. It was also impacted by the availability of other team members who felt confident to support the birth, which meant less on-call time was required from individuals to support the service. Information was available about 78 births.

Table 10: Time spent on-call

	Number of births	Range (min-max)	Mean	Std Dev
Total days on-call	78	0 – 16	3.38	4.267
Total nights on-call	78	0 – 29	6.49	7.632

When midwives work in on-call arrangements, for example in home birth teams, they are commonly paid a reduced rate for time spent on-call and an enhanced hourly rate if they are called in. At one site, the on-call rate is £1.49 per hour and time and a half when called in. However, breech specialists attend births to support the birthing person and their attending care providers, rather than to provide all clinical care. In this feasibility study only one member of staff reported receiving payment for time spent on-call, which was already part of her role within a community team. At most sites, being on-call for breech births was voluntary, eg. staff volunteered to attend if they were available, and/or was seen as a training opportunity for an extended role. All members of staff reported receiving back time-in-lieu or payment via staff bank arrangements if they had attended a VBB outside of their scheduled working hours.

Costs of proficiency development

Due to severe staffing shortages throughout the pandemic, sites were not able to support multiple people to be on-call. Therefore, other members of the team acquired experience with support of more experienced professionals on an ad hoc basis. Because of this, proficiency levels throughout the rest of the team developed more slowly than anticipated. In September 2022, one of the lead sites reported the first additional team member reaching proficiency, one year and nine months after the start of OptiBreech 1. Therefore, our cost projections are hypothetical, based on the NHS reference costs of a Band 7 midwife and an estimated 8 hours spent at each birth. This was an agreed estimation following discussion with PIs at the lead sites.

In Table 11: Costs associated with achieving breech proficiency through a breech clinic rotation, the estimated potential costs of training one Band 7 member of the team with minimal prior experience to full proficiency are described.(52) This is estimated to be £10,213. All NHS birth professionals attend mandatory annual training, which includes a brief vaginal breech birth update, and this is not included. The table below includes the enhanced physiological breech birth training package provided to OptiBreech team members. It also includes attendance at the 10 births to achieve proficiency and time for a currently proficient team member to attend to provide support to the trainee. This equates to an estimated £1021.13 per planned VBB, assuming the service only has one fully proficient attendant. The components included are outlined below. Where some of these competencies are already acquired, or less on-call time is needed, the cost required to achieve proficiency will be less.

Table 11: Costs associated with achieving breech proficiency through a breech clinic rotation

Training to undertake presentation ultrasound scans
	hours	cost (GBP)	total (GBP)	comment
Online or half-day theory course	3.5	62	217
10 supervised scans	3.5	62	217	Half-day in clinic with breech specialist
Cost of online training course			100
Cost of acquiring proficiency with counselling / birth planning
Observation	3.5	62	217	Half-day shadowing in clinic
Supervised practice	3.5	62	217	Half-day in clinic. Trainee continues to have access to breech specialist midwife and lead obstetrician for support.
Training to acquire proficiency in facilitating physiological breech births
On-line theoretical training	9.5	62	589	Current length of PBB online training package.
Hands-on training day	7.5	62	465	Most people need in-person training to practice manoeuvres and for repetition required for adult learning.
Supervised births (10 x 8 hours) *	80	62	4960	Based on 5 hours at birth + 1 hour travelling + 2 hours spent on-call
Cost of training package			100	Current cost of PBB in-person and on-line training package
Time spent delivering training	8	62	496	Delivering 2 hours of mandatory training activities once per quarter
Additional counselling & support from specialist	48.5	62	2635	Based on 30 minutes additional counselling and 8 hours of birth attendance, for 5/10 births
TOTAL			£10,213

An alternative training and implementation strategy, providing enhanced training to a larger number of staff, has recently been evaluated in NHS settings.(44) In that evaluation, training 195 staff to attend a one-day training was estimated to cost £62,434. In the year following training, 21/53 births were attended by professionals who had completed the training, and outcomes were better among these births than those not attended by someone who had not completed the enhanced training. This equates to a cost of £2973 per birth. However, 20/21 of these occurred in sites that adopted a policy of calling professionals with enhanced training to the births wherever possible. In sites where this did not occur, providing enhanced training to significant numbers of staff resulted in minimal benefit. In services where overall skill levels have been depleted, targeted training and development of a small number of staff enabled to work flexibly(33) and calling them to VBBs wherever possible appears to be a more cost-effective initial implementation strategy.

The estimate above has been prepared to support current and future sites seeking to train staff working in a dedicated clinic with a breech specialist midwife.(43) One site is currently being funded to evaluate the accuracy of this estimate. Observational data about the time taken for specific tasks, such as counselling or facilitating a transfer of care, is needed. In further research, CRFs should also identify number of hours of on-call time and additional unscheduled hours paid per birth, to accurately quantify the costs of providing the service in various contexts.

6. Safety

The purpose of reporting safety outcomes in a feasibility study is to identify potential safety risks that would prevent a substantive study. The OptiBreech 1 study collected data on Serious Adverse Events (SAEs), neonatal admissions directly following birth and neonatal deaths only to ensure there was no obvious safety concern. All SAEs and neonatal admissions were reviewed with the Study Steering Committee.

Four neonatal admissions occurred following birth (4/82, 4.9%), one serious adverse outcome (1/82, 1.2%), and no neonatal deaths. The neonatal admission rate among actual vaginal breech births was 3/40, 7.5%. One of the neonatal admissions followed an in-labour caesarean after a bradycardia, with a breech presentation undiagnosed antenatally but vaginal birth attempted. No resuscitation was required, but the infant was admitted with suspected sepsis, and the mother was a known GBS carrier.

Two neonatal admissions occurred following prolonged second stages, which also involved circumstantial factors (theatre not being available). This included disagreement within the team as to whether a caesarean was indicated, and in the most serious case with the woman herself, who requested a caesarean in the second stage of labour. Following discussion with the SSC, further guidance around second-stage decision-making was provided to teams, and this has been incorporated into the OptiBreech Care Trial’s clinical guidance. Sites were also encouraged to honour any woman’s request for a caesarean in labour, while recognising that sometimes this is not possible.

The fourth neonatal admission occurred following delay during emergence of the baby. The attendant had completed physiological breech birth training, but the site had not yet appointed a breech lead midwife. Following discussions with the CI and the SSC, the site was paused to recruitment until further face-to-face training could occur. Continual learning through discussion with sites contributed to on-going refinement of the OptiBreech training to support sites’ needs.

The research team originally planned to collect data on all breech births at participating sites for two years before the start of the study and during the study. However, extracting this data was difficult for sites to do without additional funding during the pandemic. Therefore, data about the two years prior to the start of the study was only received from five sites. In these sites, 61 vaginal breech births occurred during this time, with a neonatal admission rate following birth of 13% (8/61), including one neonatal death. Although neonatal admission is a poor proxy for serious and long-term outcomes, it has economic implications and has been associated with poorer long-term outcomes following vaginal breech births.(53)

The only other available data comes from the previous evaluation of the physiological breech birth training package used in the OptiBreech 1 study. In that study, among births where no one who had attended the training was present, the incidence of serious neonatal morbidity was 5/69 (7.2%), compared to 0/21 among births where someone who had completed the training was present.(44)

The rate of neonatal admission following vaginal breech births on the OptiBreech 1 study was 7.5% (3/40), and one serious adverse outcome occurred (2.5%, 1/40). There is no indication not to proceed with further research on safety grounds, as the available prospectively collected data suggest a possible improvement in outcomes. Future research should aim to collect data on all breech births occurring within OptiBreech settings.

7. Effectiveness

Demographics

Because the aims of this study were focused on determining whether sites were able to implement the team model, very basic demographic data was collected. The focus was on data that would give us insight into the challenges that may be faced in a future trial.

Table 12: OptiBreech 1 Basic Demographics

	nulliparous	multiparous
Parity	41/82 (50.0%)	41/82 (50.0%)

	yes	no
Diagnosed prior to labour	71/82 (86.6%)	11/82 (13.4%)
Had an attempt at ECV^*	56/71 (77.5%)	15/71 (21.1%)

* Antenatal diagnosis only (71/82)

Parity

Approximately 63% of women with a breech-presenting baby at term are nulliparous.(54)

In our sample, 41/82 (50.0%) were nulliparous and 41/82 (50.0%) were multiparous. This likely reflects increased reluctance from clinicians and women to attempt a VBB in a first pregnancy.

Diagnosis prior to and/or during labour

In accordance with the protocol developed in collaboration with our PPIE group, women who had received OptiBreech Care in labour following an undiagnosed breech presentation were recruited retrospectively. At the same time, women were offered an opportunity to discuss their birth experience and ask questions about what had happened and why. This applied to 11/82 (13.4%) of our sample, including 6 nulliparous women and 5 multiparas. This is lower than the overall undiagnosed breech in labour rate in our settings (20-30%),(55,56) and probably reflects the impact of self-referrals with known breech presentations on the sample. We included two women in our interviews who were recruited retrospectively. Our retrospective recruitment methods seem to be acceptable to those who participated in an interview, with the additional support of the OptiBreech team very welcome.

Diversity

Demographic data on participant’s ethnic backgrounds or primary languages was not collected during this first stage of the study. However, staff reported it was more challenging and time consuming to discuss consent when the woman required translation services, whether antenatally or postnatally. Multiple PIs reported that women from immigrant communities, who do not speak English as their primary language, also seemed to have higher levels of distrust around participation in research. Women expressed concerned to PIs about sharing personal details and the potential for inter-agency sharing of personal information, such as informing the GP of participation in research or long-term follow-up. If these women have had poor experiences with health services or other UK agencies, this distrust is perfectly reasonable, but if it therefore limits their ability to access participation in research, this must be addressed.

Because of these challenges, the research team will aim in future projects to collect anonymised outcome data about the entire breech cohort at participating sites. Explicit consent and personal data will only be collected where necessary due to randomisation or intention for long-term follow-up. Women would still be fully informed that clinical data is collected, with opt-out capability, but they will also be reassured that their personal information is not collected without explicit consent. Talking to women informally about their concerns and discussing this option with our PPIE group has suggested this will help to reassure women that they are not being targeted because of their immigration status or experimented on for research purposes, and that personal information will not be shared beyond their direct care providers. It will also help to ensure that outcomes for the most vulnerable women are not lost, and that the ultimate outcomes of the research are not a biased reflection of what can be achieve for the most privileged women.

Mode of birth

Mode of birth data was collected to identify potential futility of conducting future research, based upon the rates of vaginal births achieved.

Table 13: OptiBreech 1 Mode of Birth Outcomes

	Total sample (%)	Total w/o maternal request planned CB	Total w/o planned CB
vaginal breech birth	38 (46.3)	38 (52.1)	38 (57.6)
forceps breech	2 (2.4)	2 (2.7)	2 (3.0)
cephalic birth	3 (3.7)	3 (4.1)	3 (4.5)
total vaginal births	43 (52.4)	43 (58.9)	43 (65.2)
in-labour CB	23 (28.0)	23 (31.5)	23 (34.8)
planned CB	16 (19.5)	7 (9.6)	-
total CB	39 (47.5)	30 (41.0)	23 (34.8%)
TOTAL	82	73	66

Table 13 presents the mode of birth outcomes following intended vaginal breech birth in the OptiBreech 1 study. Cephalic births after spontaneous version are included because that is one of the outcomes of intention-to-treat by awaiting spontaneous labour. Outcomes are reported as a total sample (82), as a sample with those who changed their minds and requested a pre-labour caesarean removed (72), as a sample with all pre-labour CB removed (66). Our sample corresponds to the current RCOG guidance that, when a vaginal breech birth is planned, a CB will be performed approximately 40% of the time. Approximately 32% of the time, this will be in labour. These results will help to inform counselling in future research.

External cephalic version

Among the 71 women whose breech presentation was diagnosed prior to labour, 56/71 (78.8%) had an attempt at ECV and 15/71 (21.1%) chose not to (Table 9).

Table 14: Mode of birth stratified by parity and ECV attempt

	nulliparous	multiparous	attempted ECV	no ECV attempt
vaginal breech birth	14 (34.1)	24 (60.0)	23 (41.1)	15 (57.7)
forceps breech	2 (4.9)	0	1 (1.8)	1 (3.8)
cephalic birth	0	3 (7.5)	3 (5.4)	0
Total vaginal births	16 (39.0)	27 (67.5)	27 (48.2)	16 (61.5)
In-labour CB	14 (34.1)	9 (22.0)	17 (30.4)	6 (23.1)
Total vaginal births after labour	16/30 (53.3)	27/36 (75.0)	27/44 (61.4)	16/22 (72.7)
planned CB	11 (26.8)	5 (12.2)	12 (21.4)	4 (15.4)
Total CB	25 (60.9)	14 (34.2)	29 (51.8)	10 (38.5)
TOTAL	44	41	56	26

Modes of birth differ between parous and non-parous women. This will inform counselling in future research. In OptiBreech 1, women who had no previous attempt at ECV gave birth vaginally more often (61.5%) than those who did have an attempt (48.2%).

Reasons for caesarean birth

Table 15: Overall Indications for CB

Reason	Number /39 (%)	Pre-labour CB /16 (%)	In-labour CB /23 (%)
Delay in labour	12 (30.8)		12 (52.2)
Changed mind/maternal request	9 (23.1)	9 (56.3)
Maternal indication for delivery	4 (10.3)	3 (18.8)	1 (4.3)
Footling presentation	4 (10.3)	1 (6.3)	3 (13.0)
High estimated fetal weight	3 (7.7)	1 (6.3)	2 (8.7)
Non-reassuring fetal condition	2 (5.1)	1 (6.3)	1 (4.3)
Oligohydramnios	2 (5.1)	1 (6.3)	1 (4.3)
Cord prolapse	1 (2.6)		1 (4.3)
Advised against by non-OptiBreech professional	1 (2.6)		1 (4.3)
Premature rupture of membranes	1 (2.6)		1 (4.3)

The results of the OptiBreech 1 feasibility study indicate that it is possible to implement OptiBreech team care for vaginal breech births to test it in a randomised trial. This premise was tested during a pandemic, in contexts with low overall experience and proficiency levels at the start of the study. The model depends on the motivation of front-line clinicians to deliver the intervention and the research, and the support of their colleagues and management. These factors should be taken into consideration along with other insights gained from qualitative work in future site selection. In addition, for approximately 1:10 births, an OptiBreech-trained attendant may not be available, due to the unpredictability of spontaneous labour. Women should be informed of this possibility, and future research should monitor this and its association with outcomes. The next stage of this research is a substantive prospective observational cohort study with an embedded pilot randomised trial comparing OptiBreech Care with standard care in four sites.

Ethics approval and consent to participate

This study was reviewed and approved by the East of England – Cambridgeshire and Hertfordshire Research Ethics Committee (20/EE/0287). Each participant provided written consent to participate via a written or e-consent form.

Consent for publication

Not applicable.

Availability of data and materials

The datasets generated and analysed during the OptiBreech 1 study are available in the Figshare repository, https://doi.org/10.6084/m9.figshare.c.6238653.v2.

Competing interests

SW and ES are co-Directors of Breech Birth Network, Community Interest Company, a not-for-profit social enterprise that delivers vaginal breech birth training and supports research. They and other members of the OptiBreech Collaborative have received teaching fees and expenses for providing breech training.

Funding

Shawn Walker is funded by a National Institute of Health and Care Research (NIHR) Advanced Fellowship (300582). Jane Sandall at King’s College is an NIHR Senior Investigator. Both are supported by the NIHR Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care, who played no role in conducting the research and writing the paper. Breech Birth Network provided training, educational resources and funding for conference presentations.

Authors’ contributions

SW conceptualized the research, acquired the funding, led the investigation, conducted the formal analysis and was the substantial author of the report. ES, KS and AM contributed to the conceptualization, helped to lead the investigation, provided supervision for other principal investigators and reviewed the final manuscript. TD and SD contributed to data curation, analysis of data, project administration, validation of data, and review of the final manuscript. JS and AS contributed to the conceptualisation, methodology and senior supervision of the project, and reviewed the final manuscript.

Acknowledgements

The OptiBreech Collaborative includes: Avni Batish (Surrey and Sussex Healthcare NHS Trust, East Surrey Hospital), Louisa Davidson (Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham Women’s Hospital), Sabrina Das (Imperial College Healthcare NHS Trust, Queen Charlotte’s and Chelsea Hospital), Lenka Magurova (Lewisham and Greenwich NHS Trust), George Haroun (Cwm Taf Morgannwg University Health Board, Prince Charles Hospital), Charlotte Meates (Cwm Taf Morgannwg University Health Board, Prince Charles Hospital), Gillian Houghton (Liverpool Women’s NHS Foundation Trust) and Helen Le Grys (Royal Cornwall Hospital).

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CONSORTCHECKLIST.docx

The OptiBreech Care Pathway: evaluating the feasibility and acceptability of team care for women seeking to plan a vaginal breech birth (OptiBreech 1) – a mixed methods implementation feasibility study

Status:

Journal Publication

Version 1

Abstract

Background

Methods

Results

Conclusions

Figures

Key Messages

Background

Proposed intervention

Aims and objectives

Methods

Study design

Patient and Public Involvement and Engagement

Oversight: Study Steering Committee

Participants

Women and pregnant people

Staff

Intervention

Outcomes

Changes to study design

Results and Discussion

1. Trial feasibility

Recruitment

Non-recruiting or non-opening sites

Building research capacity building

2. Intervention feasibility

Background experience and confidence

OptiBreech-trained attendants

Fully proficient attendants

3. Fidelity to physiological breech birth practice

Maternal birth position

Maternal movement and effort

Pelvis-to-birth interval <5 minutes

Rumping-to-birth interval <7 minutes

Resuscitation with umbilical cord intact

4. Acceptability

Source of referral

5. Costs

Time spent on-call

Costs of proficiency development

6. Safety

7. Effectiveness

Demographics

Diagnosis prior to and/or during labour

Diversity

Mode of birth

External cephalic version

Reasons for caesarean birth

Conclusion

Declarations

Ethics approval and consent to participate

Consent for publication

Availability of data and materials

Competing interests

Funding

Authors’ contributions

Acknowledgements

References

Supplementary Files

Status:

Journal Publication

Version 1