Sadiq 2011

Methods	2‐arm active‐controlled randomised trial.
Participants	Between November 2009 and September 2011, 1865 parturients were randomised in a hospital setting in Nigeria. The population comprised women of parity 6 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing instrumental delivery, or those with diabetes, non‐cephalic presentation, anaemia, antepartum haemorrhage, multiple pregnancy, grand multiparity (more than 6) or known allergy.
Interventions	10 IU of oxytocin administered by an intravenous bolus (n = 900) versus 600 mcg of misoprostol administered orally (n = 900).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, blood loss (mL), change in Hb level.
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	Random assignments were generated by dice‐box.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not reported.
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	Assessor blinding was not reported.
Objective assessment of blood loss	High risk	Investigators evaluated blood loss at delivery by collection with pre‐calibrated kidney dishes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"46 of the administered questionnaires were invalidated leaving a total of 1819 valid questionnaires (912 for oxytocin and 907 for misoprostol). The data were further reduced through a process of computer randomisation so as to have [an] equal study population in the 2 medication groups: oxytocin group (900 subjects) and misoprostol group (900 subjects)”.
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 University of Maiduguri Teaching Hospital. Study medications were donated by Emzor Pharmaceutical Industries.