Australia 1999.

Methods	Random allocation from a table of random numbers with sequentially numbered, sealed, opaque envelopes. Block randomisation was utilized. The study was not blinded.
Participants	930 women with vaginal delivery in 4 centres in Australia, China, and Papua New Guinea. Exclusion criteria: coagulation disorders, asthma, severe renal disease, epilepsy, elective caesarean section, severe hypertension.
Interventions	Misoprostol 400 mcg orally vs IM injection of either oxytocin (10 IU) (1 centre) or ergometrine‐oxytocin (5 IU oxytocin + 0.5 mg ergometrine) (3 centres).
Outcomes	Blood loss, duration of third stage, use of additional uterotonics, blood transfusion, side‐effects, haemoglobin level. Measurement of blood loss: by combining estimated (assessment by clinician) and measured (measuring volume with calibrated measuring jug, and weighing of linen). It is unclear if some centres used 1 or the other method.
Notes	Management of third stage: no mention of third stage management technique. 31/455 (7%) were excluded after randomisation in the misoprostol group, and 36/475 (8%) were excluded after randomisation in the oxytocin/ergometrine‐oxytocin group.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization was by random number list in blocks of 20 with a separate randomization for each center."
Allocation concealment (selection bias)	Low risk	"Sequentially numbered sealed security (opaque) envelopes containing the appropriate drug label were provided for each center."
Blinding (performance bias and detection bias) All outcomes	High risk	"Not blinded."
Incomplete outcome data (attrition bias) All outcomes	Low risk	94 patients were excluded prior to randomisation and 31 patients (6.8%) from the misoprostol arm and 36 patients (7.6%) from the control arm have been excluded after randomisation. The main reasons for exclusion prior to randomisation and following randomisation were the need for caesarean sections and the development of hypertension.
Selective reporting (reporting bias)	Low risk	Primary outcomes of the review have been reported.
Other bias	High risk	This trial was stopped after recruitment of 863/1862 women following the unsatisfactory results of an interim analysis. Patient characteristics prior to treatment showed no differences between the groups.