Badejoko 2012

Methods	2‐arm active‐controlled double‐dummy randomised trial.
Participants	Between 1st April 2009 and 31st December 2009, 264 parturients were randomised in a hospital setting in Nigeria. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at high risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients in the second or third stage of labour, or those with cervical lacerations or coagulopathy.
Interventions	30 IU of oxytocin administered by an intravenous bolus plus infusion (n = 132) versus 20 IU plus 600 mcg of misoprostol plus oxytocin administered rectally plus by an intravenous infusion (n = 132).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, morbidity, additional uterotonics, transfusion, death, blood loss (mL), vomiting, fever, shivering.
Notes	Contact with study authors for additional information: no. Additional data from authors: no.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation code produced by an independent statistician using a computer‐generated random number sequence.
Allocation concealment (selection bias)	Low risk	Investigators used sequentially numbered sealed packets made of identical opaque brown‐paper envelopes prepared by the hospital pharmacy.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Study participants and caregivers were blinded to treatment allocations.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors were blinded to treatment allocations.
Objective assessment of blood loss	Low risk	Investigators evaluated blood loss by collection with a BRASS‐V calibrated drape "which is a sterile intrapartum blood collection mat with a calibrated receptacle" placed under the mother after the delivery of the baby and immediate clamping of the umbilical cord. The drape included ribbons tied around the abdomen of the mother to optimise blood collection.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"6 women from the misoprostol group and 3 from the oxytocin group were excluded from statistical analysis. 5 of these women in the misoprostol group and all 3 in the oxytocin group were excluded because of the occurrence of cervical lacerations in them. The sixth woman excluded in the misoprostol group had developed features of disseminated intravascular coagulopathy (DIC). Analysis was thus based on 255 parturients (126 in the misoprostol group and 129 in the oxytocin group)."
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	High risk	Those who withdrew from the study after randomisation were not included in the analysis.
Funding source	Low risk	The study was conducted without external funding.