Substantive trial feasibility
death, TSC
RECRUITMENT
The pilot trial met two pre-specified green and one amber substantive trial feasibility criteria. The minimum effectiveness target was met, as the vaginal birth rate among women randomised to OptiBreech care was >30% and greater than that among women randomised to standard care. The safety target was met, as there were no instances of Apgar <7 at 5 minutes or death in either arm. The trial fell into the ‘amber’ criteria for progression to a substantive trial for the recruitment target. Sites were on target to achieve the pre-specified sample; however, the original overall target was not met due to the decision to stop randomisation. Women only planned a VBB within the OptiBreech care cohort or when randomised to OptiBreech care. The TSC concluded that the demand for VBB was sufficient for a large observational cohort study, but 1:1 randomisation does not appear a feasible way of evaluating the safety of VBB between standard care and OptiBreech care. Because this was clear at the interim analysis, further randomisation was not perceived to add additional value.