OptiBreech collaborative care versus standard care for women with a breech-presenting fetus at term: A pilot parallel group randomised trial to evaluate the feasibility of a randomised trial nested within a cohort.

OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term, with continuity from a breech specialist midwife, including where chosen, for vaginal breech birth (VBB). Pilot randomised trial using unblinded 1:1 parallel group allocation to OptiBreech versus standard care, within a cohort. Participants were women with a breech-presenting fetus > 33 weeks, at four sites in England, January-June 2022. A two-stage consent process was used. Participants consented to undergo random selection to be offered a 'new care process', with a choice to accept it, or not. Primary objectives were to identify recruitment, acceptance, and attrition rates. Randomisation procedures and potential primary outcomes for a substantive study were also feasibility-tested. 68 women were randomised between January-June 2022. The consent process was acceptable to participants, but randomisation was unacceptable to women who specifically sought OptiBreech care. Two women withdrew due to concerns about sharing personal information. More women planned a VBB when randomised to OptiBreech Care (23.5% vs 0, p = .002, 95% CI = 9.3%,37.8%). Women randomised to OptiBreech care had: lower rates of cephalic presentation at birth (38.2% vs 54.5%), higher rates of vaginal birth (32.4% vs 24.2%), lower rates of in-labour caesarean birth (20.6% vs 36.4%), lower rates of neonatal intensive care (5.9% vs 9.1%), and lower rates of severe neonatal morbidity (2.9% vs 9.1%). Randomisation was stopped on the advice of the steering committee before the planned sample of 104, as lack of access to VBB within standard care prohibited comparison of outcomes. Demand for VBB is sufficient for a cohort study, but comparison of outcomes by 1:1 randomisation is not feasible. OptiBreech care would be best evaluated using stepped wedge cluster randomisation. Funded by the United Kingdom National Institute for Health and Care Research (NIHR300582). Clinical trial registration: ISRCTN 14521381.

The feasibility of team care for women seeking to plan a vaginal breech birth (OptiBreech 1): an observational implementation feasibility study in preparation for a pilot trial.

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 prior to proceeding with a planned pilot randomised controlled trial. METHODS: Our design was an observational implementation 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), within existing resources (costs), while maintaining low neonatal admission rates (safety) and adequate recruitment rates (trial feasibility). Participants included women > 37 weeks pregnant with a breech-presenting foetus, requesting support for a vaginal breech birth following standard counselling, and staff involved in the study. No randomisation occurred in this first stage of feasibility work. RESULTS: Thirteen National Health Service sites were recruited. A total of 82 women planned births in the study. Sites with a breech specialist midwife recruited at double the rate of sites without (0.90/month, 95% CI 0.64-1.16 vs 0.40, 95% CI 0.12-0.68). 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, 95% CI 0.732-0.958) and by staff who met additional proficiency criteria at 67.5% (27/40, 95% CI 0.509-0.814). Fidelity criteria were more consistently met by staff who also met proficiency criteria. There were four neonatal admissions (4.9%, 4/82), including one serious adverse outcome (1.2%, 1/82). CONCLUSIONS: A prospective observational cohort of OptiBreech collaborative care, which could potentially support nested or cluster randomisation, appears feasible in sites willing to establish a dedicated clinic and strategically develop further proficient members of staff, with back-up plans for supporting rapidly progressing births. Randomisation procedures remain to be feasibility tested. It is funded by the NIHR (NIHR300582).

Optimal time intervals for vaginal breech births: a case-control study.

Background: Breech births are associated with a high rate of hypoxic injury, in part due to cord occlusion during emergence. Maximum time intervals and guidelines oriented toward earlier intervention have been proposed in a Physiological Breech Birth Algorithm. We wished to further test and refine the Algorithm for use in a clinical trial. Methods: We conducted a retrospective case-control study in a London teaching hospital, including 15 cases and 30 controls, during the period of April 2012 to April 2020. Our sample size was powered to test the hypothesis that exceeding recommended time limits is associated with neonatal admission or death. Data collected from intrapartum care records was analysed using SPSS v26 statistical software. Variables were intervals between the stages of labour and various stages of emergence (presenting part, buttocks, pelvis, arms, head). The chi-square test and odds ratios were used to determine association between exposure to the variables of interest and composite outcome. Multiple logistic regression was used to test the predictive value of delays defined as non-adherence the Algorithm. Results: Logistic regression modelling using the Algorithm time frames had an 86.8% accuracy, a sensitivity of 66.7% and a specificity of 92.3% for predicting the primary outcome. Delays between umbilicus and head >3 minutes (OR: 9.508 [95% CI: 1.390-65.046] p=0.022) and from buttocks on the perineum to head >7 minutes (OR: 6.682 [95% CI: 0.940-41.990] p=0.058) showed the most effect. Lengths of time until the first intervention were consistently longer among the cases. Delay in intervention was more common among cases than head or arm entrapment. Conclusion: Emergence taking longer than the limits recommended in the Physiological Breech Birth algorithm may be predictive of adverse outcomes. Some of this delay is potentially avoidable. Improved recognition of the boundaries of normality in vaginal breech births may help improve outcomes.

When babies are born bottom-first, there is a risk that the baby could be starved of oxygen during the birth. To help prevent this, researchers developed a flowchart to guide when to help a baby out, the Physiological Breech Birth Algorithm. The first version was based on a study of actual breech birth videos and recommends that the birth should be complete within 7-5-3 minutes from buttocks-pelvis-umbilicus visible. This is different from current national guidance not to intervene until 5 minutes after the baby's pelvis is born. We are using this new algorithm to guide midwives and doctors in the OptiBreech Care Trial, so we wanted to make sure it is safe and accurate.

Physiological breech birth training: An evaluation of clinical practice changes after a one-day training program.

BACKGROUND: The "physiological breech birth" one-day training program is based on evidence about the physiology of breech births and how clinicians learn breech skills. Previous evaluations have demonstrated positive effects on confidence and knowledge, but the training's effect on clinical practice and outcomes is unknown. METHODS: A mixed-methods evaluation was conducted in eight National Health Service hospitals in England and Northern Ireland. Changes in confidence and knowledge were assessed using pretraining and post-training surveys. Mode of birth and maternal birth positions were evaluated using audit data covering one year before the training and one year after, for all singleton vaginal breech births at term. FINDINGS: A total of 263 participants completed the surveys. Confidence in managing breech births in both upright and supine positions significantly increased, as did participant knowledge. Audited data for 1402 women were collected. Overall vaginal birth rates remained similar in both periods. Among singleton vaginal breech births >37 weeks, the use of upright birthing positions increased significantly (P = .002). The study was not powered to detect differences in other outcomes, but pilot data were collected to inform the design of future studies. CONCLUSIONS: Increase in use of upright birthing positions suggests that physiological breech birth training is likely to lead to clinical practice changes, which may help support maternal choice in line with current guidance. However, provision of a one-day training program did not change overall vaginal breech birth rates. Adequately powered research is needed to determine effects of clinical practice changes on clinical outcomes.

Face-to-pubes rotational maneuver for bilateral nuchal arms in a vaginal breech birth, resolved in an upright maternal position: A case report.

BACKGROUND: A physiological breech birth is one in which the woman is encouraged to remain active throughout her labor and able to assume the position of her choice for the birth. Use of this strategy within the United Kingdom National Health Service has led to the use of innovative maneuvers to relieve obstruction when women give birth in upright positions, for example, kneeling or standing. This includes use of the face-to-pubes rotational maneuver to relieve extended nuchal arm(s). In this paper, we report a case where the face-to-pubes rotational maneuver was used to relieve bilateral nuchal arm entrapment in a breech birth. METHODS: Single-case study. We aimed to generate an in-depth understanding of how this maneuver works and how professionals decide to use it by exploring its use in a real-life context. RESULTS: The face-to-pubes rotational maneuver appears to be an effective method of relieving nuchal arm entrapment when used by experienced hands. In cases of bilateral nuchal arm entrapment, elevation to a higher station may be necessary to dis-impact the arms above the pelvic inlet before the fetus can be rotated. After face-to-pubes rotation and release of arms, the head should be realigned in an occiput anterior position for delivery. CONCLUSION: The face-to-pubes rotational maneuver can be taught for resolution of nuchal arms in an upright position. Parents should be informed of the availability or not of a specialist midwife trained in physiological breech birth, as this may be important to their decision-making.