Kundodyiwa 2001

Methods	2‐arm placebo‐controlled randomised trial.
Participants	Between October 1999 and February 2000, 500 parturients were randomised in a hospital setting in Zimbabwe. The population comprised women of unspecified parity, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing instrumental delivery, or those with previous PPH, antepartum haemorrhage, coagulopathy, multiple pregnancy, asthma or allergies to prostaglandins or oxytocin.
Interventions	400 mcg of misoprostol administered orally (n = 243) versus 10 IU of oxytocin administered intramuscularly (n = 256). There was 1 exclusion post randomisation but it was unclear as to which group it was randomised to.
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, morbidity,additional uterotonics, transfusion, manual removal of placenta, death, blood loss (mL), third‐stage duration (min), nausea, vomiting, fever, shivering.
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 using a computer‐generated random sequence.
Allocation concealment (selection bias)	Low risk	The participant was asked to randomly pick a numbered sealed opaque envelope from the study cooler‐box.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"Identical placebo tablets could not be obtained from the manufacturers. The tablets were similar in size and colour but not in shape. However, most reviewed trials on misoprostol had this similar problem although this method of blinding proved to be effective."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"The data sheet was completed by the midwife supervising the delivery and collected and checked by the research assistant."
Objective assessment of blood loss	Low risk	After delivery, investigators evaluated blood loss by removing linen soiled with amniotic fluid, and then placing a fresh disposable incontinence pad with a plastic backing under the mother. Blood expressed from the uterus was measured with a calibrated measuring jug. The volume of blood soiling linen savers and sanitary pads was determined as the difference between dry weights and soiled weights: these measurements were added to the volume recorded by the calibrated jug.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Data for 1 woman were excluded because she delivered undiagnosed twins after randomisation."
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.