Bellad 2012

Methods	2‐arm active‐controlled double‐dummy randomised trial.
Participants	Between dates unspecified, 652 parturients were randomised in a hospital setting in India. The population comprised women of unspecified parity, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing caesarean section or instrumental delivery, or those with medical disorders, in active labour with more than 4 cm dilatation or stillbirths.
Interventions	400 mcg of misoprostol administered sublingually (n = 321) versus 10 IU of oxytocin administered intramuscularly (n = 331).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, morbidity, additional uterotonics, transfusion, manual removal of placenta, death, blood loss (mL), third‐stage duration (min), nausea, vomiting, fever, shivering, abdominal pain.
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	Participants were assigned to treatment with a 1:1 ratio using computer‐generated simple randomisation.
Allocation concealment (selection bias)	Low risk	The study medications and placebos were packaged in appropriately coded envelopes by administrative staff from the department of clinical pharmacy.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Study participants and 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 by collection with a BRASS‐V calibrated drape placed under the mother before delivery of the baby. "The calibrated blood collection receptacle was opened after delivery and drainage of amniotic fluid. The blood collected in the drape was transferred to a measuring jar with 10 mL calibrations for accuracy. Blood‐soaked swabs were weighed in g, and the known dry weight of the swabs was subtracted; this volume was added to the measured blood volume from the drape (assuming an equivalence of 1 g and 1 mL)." Blood loss was measured at 1 and 2 hours after delivery of the baby.
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 (ClinicalTrials.gov NCT01373359).
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 Jawaharlal Nehru Medical College (the institution of the authors). Study medications were donated by Cipla (misoprostol) and AstraZeneca (oxytocin).