Randomisation and masking
BREECH PRESENTATION, BLIND
Eligible participants from the cohort were randomised to either standard care or OptiBreech care. The randomisation schedule was computer-generated using a dynamic allocation process through MedSciNet software. Minimisation factors included site, previous vaginal births (0 vs 1 or more), type of breech presentation (extended/frank vs any other or unknown), and gestation at enrolment (<36 weeks, 36–38+6, 39+ weeks). Allocation was scheduled to be equal.Allocation occurred during the enrolment process within the MedSciNet e-Case Report Form (e-CRF) database and revealed to the person taking consent. Consent and randomisation were completed either by a Clinical Research Network midwife, the Principal Investigator (PI) or the Breech Lead Midwife/Obstetrician. Person-identifiable information, once entered into the database, was automatically moved onto a separate database. The database containing person-identifiable information was accessible only through a separate login and password, to protect participants’ confidentiality. Due to the nature of the care pathway intervention, it was not possible to blind participants nor maternity care professionals. The neonatal teams assessing neonatal outcomes were not informed whether women were enrolled on the trial. Analysis of data was not blinded at this feasibility stage.