Elsedeek 2012

Methods	2‐arm placebo‐controlled randomised trial.
Participants	Between 1st January 2008 and 1st January 2009, 400 parturients were randomised in a hospital setting in Egypt. The population comprised women of parity 4 or less, a singleton pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised parturients undergoing their first elective caesarean section, or those unsure of gestation or with hypertension, diabetes, oligohydramnios, abnormal placenta or abnormal laboratory investigations.
Interventions	400 mcg plus 10 IU of misoprostol plus oxytocin administered rectally plus by an intravenous infusion (n = 200) versus 10 IU of oxytocin administered by an intravenous infusion (n = 200).
Outcomes	The study recorded the following outcomes: PPH at 1000, additional uterotonics, transfusion, blood loss (mL), change in Hb level, NNU admissions, 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 computer‐generated tables.
Allocation concealment (selection bias)	Unclear risk	Allocation was placed in sealed envelopes until the time of operation.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Attending obstetricians and other caregivers were blinded to treatment allocations.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors were blinded to treatment allocations.
Objective assessment of blood loss	Low risk	Investigators evaluated blood loss from after uterine incision, by collection in 2 separate suction sets administered by a nurse, and by weighing surgical towels before and after each operation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were collected completely from all randomised study participants.
Selective reporting (reporting bias)	Unclear risk	The study protocol was registered retrospectively (ACTRN 12611000638932).
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 the institution of the authors, or conducted without external funding.