Karkanis 2002

Methods	2‐arm active‐controlled randomised trial.
Participants	Between dates unspecified, 238 parturients were randomised in a hospital setting in Canada. The population comprised women of parity 5 or less, unspecified whether singleton or multiple pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients with coagulopathy, anticoagulation therapy, previous PPH or previous caesarean.
Interventions	400 mcg of misoprostol administered rectally (n = 100) versus 5 IU of oxytocin administered by an intravenous bolus or intramuscularly (n = 113). There were 15 exclusions post randomisation but it was unclear from which group.
Outcomes	The study recorded the following outcomes: additional uterotonics, transfusion, manual removal of placenta, change in Hb level. third‐stage duration (min), nausea, vomiting, headache, fever, shivering, abdominal pain.
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	A statistician developed blocked randomisation tables for each centre.
Allocation concealment (selection bias)	Low risk	Pharmacy assembled consecutively‐numbered opaque, sealed packets that contained the group allocation.
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	Methods of evaluating blood loss were not reported.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"13 women randomised subsequently delivered by caesarean and were excluded from analysis. 2 women were lost to follow‐up early in the trial when their packets were opened but the manoeuvre was not completed and no data were recorded."
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	High risk	Not all study participants were included in the analysis.
Funding source	Low risk	The study was supported by funding from the physicians of Ontario, through the Physician Services Incorporated Foundation (public funding).