Randomization, blinding, and allocation concealment
SECONDARY
Patients providing informed consent and meeting all eligibility criteria were randomly assigned via computer-generated sequence (1:1), stratified by planned delivery modality (SVD or CD) at the time of consent. The randomization sequence was created and maintained by Clinical Trials Services at SHSC to maintain blinding and allocation concealment. Consenting participants were randomized (next kit in sequence issued by research pharmacy) when admitted to the labour and delivery unit. The research pharmacy at SHSC created identical appearing study kits, with unique codes based on the randomization sequence. The study kit was prepackaged to include a filled 10 mL syringe of IP, a 50 mL bag of 0.9% saline, and a secondary infusion line. The master list linking codes with group allocation was kept in the possession of the research pharmacy to maintain blinding until data collection and analysis were complete.