Walley 2000

Methods	2‐arm active‐controlled double‐dummy randomised trial.
Participants	Between 15th June 1998 and 15th May 1999, 401 parturients were randomised in a hospital setting in Ghana. The population comprised women of parity 5 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing induction or augmentation of labour or caesarean section, or those with grand multiparity (more than 5), multiple pregnancy, preterm labour (less than 32 weeks), hypertension in pregnancy, HELLP syndrome, polyhydramnios, previous PPH, coagulopathy, precipitate labour, chorioamnionitis, Hb less than 80 g/L or a known hypersensitivity to prostaglandins.
Interventions	400 mcg of misoprostol administered orally (n = 203) versus 10 IU of oxytocin administered intramuscularly (n = 198).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, manual removal of placenta, death, blood loss (mL), Change in Hb level, third‐stage duration (min), nausea, vomiting, fever, 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	Randomisation was achieved using computer‐generated random numbers.
Allocation concealment (selection bias)	Low risk	Investigators used sequentially‐numbered, opaque packets made by administrative staff.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The identity of the placebo and active medications were concealed from caregivers and participants."
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 blood loss by the estimation of attending physicians.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Of those women randomised, blood loss measurements were unavailable in 3 cases, and postpartum Hb samples were unavailable in 9 cases.
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	Low risk	The study was supported by funding from MaterCare International and the Canadian International Development Agency (public funding).