Un Nisa 2012

Methods	2‐arm active‐controlled randomised trial.
Participants	Between 1st January 2012 and 30th June 2012, 100 parturients were randomised in a hospital setting in India. The population comprised women of parity 2 to 4, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients with previous PPH, multiple pregnancy, previous caesarean, macrosomia, pre‐eclampsia, diabetes, cardiac/lung/bleeding/clotting disorders or taking anticoagulants.
Interventions	10 IU of oxytocin administered by an intravenous bolus (n = 50) versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered intramuscularly (n = 50).
Outcomes	The study recorded the following outcome: PPH at 500.
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	Study participants (patients) were divided by a lottery system in the 2 groups, each group comprising 50 patients.
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	Unclear risk	Assessor blinding was not reported.
Objective assessment of blood loss	Low risk	Investigators evaluated blood loss after the delivery of baby "by squeezing the soaked pads and quantifying the amount of blood clots in a kidney tray of standard size to be equal to 500 mL."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The study authors did not mention any incomplete outcome data.
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	Unclear risk	The authors did not specify whether 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.