Chaudhuri 2015

Methods	2‐arm active‐controlled double‐dummy randomised trial.
Participants	Between 1st October 2012 and 31st December 2013, 396 parturients were randomised in a hospital setting in India. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at high risk for PPH, who delivered by emergency caesarean section. Exclusion criteria comprised parturients requiring conversion to general anaesthesia, or those with cardiovascular, hepatic, or haematological disorders or any contraindication for the use of misoprostol or oxytocin.
Interventions	400 mcg plus 20 IU of misoprostol plus oxytocin administered sublingually plus by an intravenous bolus and infusion (n = 198) versus 20 IU of oxytocin administered by an intravenous bolus plus infusion (n = 198).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, morbidity, additional uterotonics, transfusion, death, blood loss (mL), change in Hb level, nausea, fever, shivering.
Notes	Contact with study authors for additional information: no. Additional data from authors: no.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed using a computer‐generated random number sequence and blocks of size 8.
Allocation concealment (selection bias)	Low risk	Assignments were contained in sealed, opaque and sequentially‐numbered packets.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Randomisation and confidential record maintenance were performed by residents who were not involved in the trial, and the operation theatre midwife prepared the sealed packets and allocated and administered the drugs. Thus, clinicians, investigators, data analysts, and participants were masked to the treatment allocation."
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 intraoperative blood loss from after delivery of the placenta. Blood was collected with a suction bottle, linen savers and mops: the dry weights of these materials were subtracted from the soaked weights, and the total volume of intraoperative blood loss calculated on the basis that 1 g is equivalent to 1 mL. Investigators also evaluated postoperative blood loss by weighing soaked pads.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were collected completely from all randomised study participants.
Selective reporting (reporting bias)	Low risk	The study report matches the study protocol that was registered (CTRI 2013/05/003645).
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	Unclear risk	Source(s) of funding for the study were not reported.