Bhullar 2004

Methods	2‐arm placebo‐controlled randomised trial.
Participants	Between October 2000 and December 2002, 756 parturients were randomised in a hospital setting in the USA. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing caesarean section, or those with a bleeding disorder.
Interventions	200 mcg plus 20 IU of misoprostol plus oxytocin administered sublingually plus by an intravenous infusion (n = 377) versus 20 IU of oxytocin administered by an intravenous infusion (n = 379).
Outcomes	The study recorded the following outcomes: PPH at 500, additional uterotonics, transfusion, manual removal of placenta, death, blood loss (mL), change in Hb level, third‐stage duration (min), vomiting, shivering.
Notes	Contact with study authors for additional information: yes. Additional data from authors: yes.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Agent vials were coded with a number, which had been assigned using a random number table.
Allocation concealment (selection bias)	Low risk	Investigators used opaque vials containing either a 200 mcg misoprostol tablet or placebo.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"The placebo tablets were similar in size and colour, but not identical in shape to the misoprostol tablet."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"The placebo tablets were similar in size and colour, but not identical in shape to the misoprostol tablet."
Objective assessment of blood loss	High risk	Investigators evaluated blood loss by the estimation of attending physicians.
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.