Fawole 2011

Methods	2‐arm placebo‐controlled randomised trial
Participants	1345 parturients were randomised in a hospital setting in Nigeria. The population comprised multiparous women, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered vaginally. Exclusion criteria comprised severe allergic conditions or asthma, age below 18 years, pyrexia above 38°C, or abortion of the pregnancy.
Interventions	400 mcg of misoprostol administered sublingually plus 10 IU of oxytocin or 250 mcg to 500 mcg of ergometrine administered intramuscularly or by an intravenous bolus (n = 658) or intravenous bolus versus 10 IU of Oxytocin or 250 mcg to 500 mcg of ergometrine administered intramuscularly or intravenously (n = 660).
Outcomes	Could not include in the analysis as could not separate out the patients that received oxytocin from those who received ergometrine.
Notes	Contact with study authors for additional information: Yes. Additional data from authors: Yes, but data not provided separate for each drug used and could not be included in the meta‐analysis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Treatment was allocated in blocks of 6–8 women by the research nurse, who used a computer‐generated randomisation sequence.
Allocation concealment (selection bias)	Low risk	The trial drugs were concealed in sealed, sequentially numbered opaque envelopes.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Placebo was identical in shape, colour, size, and design.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded.
Objective assessment of blood loss	Low risk	Blood collection was initiated as soon as possible after administration of the trial medication. A low‐profile plastic fracture bedpan was placed below the woman's perineum to collect all subsequent blood loss for a period of 1 hour. Blood collected in the bedpan and all blood soaked small gauze swabs were emptied into a plastic measuring jar and the volume was measured.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No losses stated by authors but 27 women randomised were not included in the analysis for the primary outcome.
Selective reporting (reporting bias)	Unclear risk	No available protocol.
Intention to treat analysis	Unclear risk	27 women randomised were not included in the analysis for the primary outcome.
Funding source	Low risk	The trial was funded by theMedical Research Council of South Africa.