Abstract
BACKGROUND: OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term. The OptiBreech Multiple Trial Cohort is designed to host multiple trials related to care for breech presentation. This design enables prospective data collection for a large cohort of women planning a vaginal breech birth (VBB), to assess rare safety outcomes, while answering questions requiring a smaller, randomised sample nested within this cohort. METHODS: OptiBreech database currently contains participants recruited from 10 January 2022, including 67 women randomised to either OptiBreech care or standard care, and 116 women who received OptiBreech care and were not randomised. Primary outcomes included vaginal birth rate, composite neonatal morbidity and mortality and composite maternal neonatal morbidity and mortality. Descriptive statistics for the entire cohort were analysed in SPSS Version 29. Sub-group analyses were identified through participant involvement and engagement work as important to support informed decision-making. RESULTS: Of 97 women who planned a VBB at any point, 44 (45.4%) achieved a vaginal birth, compared to 29/77 (37.7%) of women who did not plan a VBB. Admission rates to a neonatal unit were similar, 4/97 (4.1%) versus 3/77 (3.9%). In this cohort, there was no severe neonatal morbidity following planned VBB, compared to 3/77 (3.9%) among the cohort who did not plan a vaginal breech birth and 2/52 (3.7%) among women who planned a cephalic birth. Severe maternal morbidity following planned VBB was 7/89 (7.9%), compared to 9/76 (11.8%) for women who did not plan a VBB and 8/54 (14.8%) for women who planned a cephalic birth. CONCLUSIONS: Planning a VBB with OptiBreech collaborative care has thus far been as safe as not planning a VBB. Detecting differences in rare outcomes will require thousands of births. Outcomes will continue to be monitored and reported here as the cohort grows.