Sood 2012

Methods	2‐arm placebo‐controlled randomised trial.
Participants	Between June 2003 and July 2005, 174 parturients were randomised in a hospital setting in India. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at high risk for PPH, who delivered by either elective or emergency caesarean. Exclusion criteria were not specified.
Interventions	400 mcg plus 20 IU of misoprostol plus oxytocin administered sublingually plus by an intravenous infusion (n = 90) versus 20 IU of oxytocin administered by an intravenous infusion (n = 84).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, blood loss (mL), change in Hb level, nausea, 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	Randomisation was achieved by computer‐generated random numbers.
Allocation concealment (selection bias)	Low risk	Investigators used sequentially‐numbered, opaque, sealed envelopes made at 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	High risk	Investigators evaluated intraoperative blood loss by collection with suction apparatus and sterile drapes before irrigation, and by evaluating the blood in abdominal swabs and gauzes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were collected completely from all randomised study participants.
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	Low risk	All those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised.
Funding source	Unclear risk	Source(s) of funding for the study were not reported.