Widmer 2010.

Methods	A computer‐generated randomisation sequence derived centrally in United States and stratified by country. Within the strata, women were individually allocated by block randomisation (varying blocks of 6 and 8).
Participants	1422 women with clinically diagnosed PPH that was suspected to be due to uterine atony, and they needed additional uterotonics. Participants were enrolled from hospitals in Argentina, Egypt, South Africa, Thailand and Vietnam. Women were not eligible for the trial if delivery was by caesarean section; misoprostol could not be given sublingually; any severe allergic or bleeding disorders (e.g. haemophilia) were recorded; temperature was higher than 38·5°C; delivery was defined as a miscarriage according to local gestational age limits; or the placenta was not delivered.
Interventions	600 μg misoprostol sublingually (3 tablets of 200 μg) or matching placebo in addition to standard care for PPH according to local protocol.
Outcomes	Primary outcome: blood loss ≥ 500 mL within 60 minutes after randomisation. Secondary outcomes: need for blood transfusion; haemoglobin concentration of less than 80 g/L within 24 hours postpartum or need for blood transfusion; median blood loss at 60 minutes and 90 minutes after randomisation; blood loss of 500 mL or more within 90 minutes after randomisation; blood loss of 1000 mL or more within 60 minutes and 90 minutes after randomisation; need for any additional uterotonic; maternal death; severe morbidity (hysterectomy or admission to a maternal intensive care unit); side effects (shivering, pyrexia, diarrhoea, vomiting or nausea) within 60 minutes and 90 minutes after randomisation; and need for any other interventions.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation sequence derived centrally and stratified by country. Within the strata, women were individually allocated by block randomisation (varying blocks of 6 and 8).
Allocation concealment (selection bias)	Low risk	Randomisation code was not shown to any participating trial centre or member of the study team until the trial was closed. To conceal allocation, treatment boxes were sealed and numbered sequentially according to the randomisation sequence and were distributed in the order that women were judged to be eligible and were enrolled in the study.
Blinding (performance bias and detection bias) All outcomes	Low risk	Treatment boxes were identical in appearance for both groups, and placebo tablets were identical to misoprostol tablets in shape, colour, weight, feel and taste.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All randomly assigned participants included in analysis.
Selective reporting (reporting bias)	Unclear risk	No prior public registration of protocol.
Other bias	Unclear risk	Outcome measure of blood loss may have included blood and other liquids collected during delivery.