Discussion
pre-labour
RECRUITMENT, BREECH PRESENTATION, BROWN
The results of the OptiBreech care feasibility pilot trial indicate that women were willing to participate, teams were able to recruit, and data required to evaluate short-term safety outcomes were complete. However, 1:1 randomisation is not the optimal design to compare outcomes for VBBs planned within OptiBreech collaborative care to those within standard care.Secondary outcomes were all positive, suggesting that OptiBreech care should be evaluated further, using a more appropriate trial design informed by this feasibility work. Care within the OptiBreech pathway enabled greater access to all three guidelines-recommended care options, compared to standard care. When randomised to OptiBreech care, more eligible women had an ECV as planned and more planned a pre-labour CB as their first option. Compared so standard care, more women randomised to OptiBreech care planned a VBB (23.5% vs 0, p = .003, 95% CI = .093,.378).Within this small feasibility sample, clinical outcomes were also better within the OptiBreech care pathway compared to standard care. Despite having lower rates of cephalic presentation at birth (38.2% vs 54.5%), women randomised to OptiBreech care had: 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%). Within the entire cohort, breech presentation on admission to labour/birth (n = 44), compared to cephalic presentation (n = 38), was associated with: lower levels of neonatal admission (2.3% versus 10.5%), lower levels of severe neonatal morbidity (2.3% vs 7.9%), fewer maternal admissions to HDU (4.5% vs 7.9%) and less severe maternal morbidity (13.6% vs 21.1%).Recruitment to the cohort of women requesting OptiBreech collaborative care (.85/month, 95% CI .74–2.44) was in line with our previous implementation feasibility study of women planning a VBB (.90/month, 95% CI .64–1.16) [This is also consistent with qualitative work involving women receiving OptiBreech care [There is sufficient evidence to conclude that current standard care is unacceptable to women who wish to plan a VBB and that clinicians frequently lack sufficient training and/or equipoise [While we can say with confidence that OptiBreech collaborative care does significantly increase access to the choice of a VBB, we do not yet know how introducing this care pathway at scale will affect clinical outcomes. To date, we have evidence from three small studies, including this pilot trial, each of which indicate an improvement in outcomes compared to standard care [Due to the unpredictability of birth, it remains unfeasible to ensure that someone meeting full proficiency criteria [Although the OptiBreech care pathway would be best evaluated with cluster-level randomisation, the randomisation procedures used in this pilot trial appeared feasible for use in trials to evaluate different interventions within the cohort with 1:1 randomisation. The mean gestation at recruitment was almost equivalent between arms and ideal for studies concerning management of breech presentation at term, at 35+6 and 35+5 in the randomised arms. Parity and type of breech presentation were also nearly equivalent. Other trials within the cohort, based on different questions, may be useful to refine the pathway to maximum clinical efficacy and economic efficiency. For example, complementary methods of encouraging babies to turn head-down remain popular with women and midwives, despite minimal evidence. OptiBreech sites each have dedicated clinics and referral pathways; the cohort study has tested consent procedures, randomisation methods and minimisation factors; and the ability to collect a complete dataset for key endpoints. Each of these create conditions for evaluating the effectiveness of these popular complementary therapies with maximum efficiency.The results of the OptiBreech feasibility work also suggest that a nested randomised trial of ECV versus non-ECV for women planning a vaginal birth could offer valuable information. The Cochrane Review on Current NICE antenatal guidelines also regard achieving cephalic presentation in labour as a critical outcome, [In our PPIE work and qualitative interviews with participants [Our subgroup equity analysis confirmed that the demographic participating in the OptiBreech trial is reflective of the multi-ethnic population in the UK. A marginally higher proportion of non-British, Black or Brown women chose to plan a VBB; this only occurred within the OptiBreech care arms of the study. The increased access provided by the OptiBreech pathway may particularly benefit groups that traditionally experience increased barriers to accessing health care. In this pilot study, these groups also experienced fewer adverse neonatal outcomes. We feel this is because the continuity provided within the OptiBreech collaborative care pathway provides relational continuity and person-centred care suited to participants’ individualised needs, in particular their need for breech expertise.