Mobeen 2011

Methods	2‐arm placebo‐controlled randomised trial.
Participants	Between June 2006 and June 2008, 1119 parturients were randomised in a community setting in Pakistan. The population comprised women of unspecified parity, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients with hypertension, non‐cephalic presentation, polyhydramnios, previous caesarean, multiple pregnancy, intrauterine death, antepartum haemorrhage or Hb less than 80 g/L.
Interventions	600 mcg of misoprostol administered orally (n = 534) versus placebo or control (n = 585).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, morbidity, manual removal of placenta, death, blood loss (mL), change in Hb level, third‐stage duration (min), nausea, vomiting, headache, 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	A computer‐generated random code in blocks of 6 was maintained by Gynuity Health Projects in New York and not revealed until data collection and cleaning were completed.
Allocation concealment (selection bias)	Low risk	Study medication was packed in numbered colour‐coded boxes by Gynuity Health Projects in New York.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Both women and TBAs were blinded to study assignment."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors were blinded to treatment allocations.
Objective assessment of blood loss	Low risk	To evaluate postpartum blood loss, blood was collected with a perineal sheet and bedpan placed under the mother for a minimum of 1 hour or until active bleeding stopped (whichever occurred last). "Blood collected in the bedpan was transferred to a measuring jar, which was then closed, and the perineal sheet and cotton roll were placed in a sealed plastic bag. The closed measuring jar and sealed plastic bag were then placed inside a plastic cooler which was tightly closed and stored in a secure place in the woman’s home until the local health visitor or community health nurse arrived for weighing, 1–2 days after delivery."
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Invalid blood loss measures, which mainly occurred when monitoring visits were not possible because of poor weather conditions, were excluded from our analysis."
Selective reporting (reporting bias)	Low risk	The study report matches the study protocol that was registered (ClinicalTrials.gov NCT00120237).
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	Low risk	The study was supported by funding from the Bill and Melinda Gates Foundation (public funding).