Cook 1999

Methods	3‐arm active‐controlled randomised trial.
Participants	Between December 1997 and December 1998, 930 parturients were randomised in a hospital setting in Australia, Papua and China. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing elective caesarean section, or those with coagulopathy, asthma, heart disease, severe renal disease, epilepsy or hypertension.
Interventions	400 mcg of misoprostol administered orally (n = 455) versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered intramuscularly (n = 310) versus 10 IU of oxytocin administered intramuscularly (n = 129).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, blood loss (mL), change in Hb level, third‐stage duration (min).
Notes	Contact with study authors for additional information: yes. 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 a random number list in blocks of 20, with separate randomisation for each centre.
Allocation concealment (selection bias)	Low risk	Investigators used sequentially‐numbered sealed security (opaque) envelopes containing the appropriate drug label for each centre.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Study participants and caregivers were not blinded to treatment allocations.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessors were not blinded to treatment allocations.
Objective assessment of blood loss	Unclear risk	Investigators evaluated blood loss by combining "estimated" and "measured" values according to the standard clinical practice of each study centre. The "estimated" blood loss was judged by the attending senior midwives and/or clinicians. The "measured" blood loss was calculated as the actual volume of blood collected in a calibrated measuring jug, combined with the difference in weight between dry and blood‐stained undersheets and sanitary pads.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were not collected completely from 67 study participants: "the main reasons for exclusion prior to randomisation, and following randomisation but before treatment, were the need for caesarean section and development of hypertension, either before or during labour. Two women (1 in each group) were not included in the analysis as no record was made of the primary outcome of blood loss."
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	Unclear risk	Source(s) of funding for the study were not reported.