Vimala 2006

Methods	2‐arm active‐controlled randomised trial.
Participants	Between August 2004 and April 2005, 100 parturients were randomised in a hospital setting in India. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by either elective or emergency caesarean. Exclusion criteria comprised parturients with multiple pregnancy, antepartum haemorrhage, polyhydramnios, prolonged labour (more than 12 hours), previous more than 1 caesarean, previous uterine rupture, cardiac/liver/renal disorder, coagulopathy or Hb less than 80 g/L.
Interventions	400 mcg of misoprostol administered sublingually (n = 50) versus 20 IU of oxytocin administered by an intravenous infusion (n = 50).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, blood loss (mL), change in Hb level, vomiting, headache,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 random numbers.
Allocation concealment (selection bias)	Low risk	Investigators used opaque, sealed envelopes.
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 intraoperatively and in the first hour postoperatively "in a standard manner." They measured the volume of blood in the suction bottle, and weighed blood‐soaked sponges and linen savers. Then they added the difference between dry and blood‐soaked weights of sponges and linen savers, to the volume measured in the suction bottle.
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 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	Low risk	The study was supported by funding from the Division of Reproductive Health and Nutrition, Indian Council of Medical Research (public funding).