Derman 2006

Methods	2‐arm placebo‐controlled randomised trial.
Participants	Between September 2002 and December 2005, 1620 parturients were randomised in a community 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 at high risk and inappropriate for home or community births according to India’s ministry of health guidelines including those undergoing elective caesarean section or breech vaginal delivery, or those previous caesarean section, Hb less than 80 g/L, antepartum haemorrhage, hypertension, multiple pregnancy, history of previous antepartum or PPH, retained placenta, uterine inversion, diabetes, heart disease, seizures, placenta praevia, asthma or contraindications to misoprostol.
Interventions	600 mcg of misoprostol administered orally (n = 812) versus placebo or control (n = 808).
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), nausea, vomiting, 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 a randomisation list with a random block size generated by the data co‐ordinating centre and stratified by the midwife.
Allocation concealment (selection bias)	Low risk	The envelopes were numbered and each envelope had a 5‐digit code number assigned to it. The first 2 digits were the auxiliary nurse midwife number, followed by a sequence number beginning with 001 and ending with 100, assigned to the individual participant. Non‐distinguishable envelopes in batches of 100 were distributed to each of the midwives affiliated with the 4 selected primary‐health centres.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The identical placebo was specifically manufactured for the study."
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 polyurethane blood collection drape placed under the mother from immediately after birth until 1 hour after delivery of the baby. The blood collection drape included a calibrated receptacle specifically developed for the study. In the event of persistent bleeding beyond 1 hour, the drape was removed at 1 hour, blood loss measured, and a new drape used with a second measurement made at 2 hours.
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 (ClinicalTrials.gov NCT00097123).
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 National Institute of Child Health and Human Development (public funding) and the Bill and Melinda Gates Foundation (public funding).