Walraven 2004.

Methods	Next in a series of randomised treatment packs in opaque envelopes with 3 tablets of misoprostol 200 mcg or placebo.
Participants	160 women who delivered vaginally with measured postpartum blood loss of 500 mL or more within 1 hour of delivery and inadequate uterine contraction thought to be the possible factor. Exclusion criteria included women who delivered by caesarean section if blood loss was less than 500 mL in first hour following vaginal delivery, if gestational age was less than 28 weeks or if inadequate uterine contraction was not thought to be the causative factor for PPH.
Interventions	Routine active management of third stage of labour with oxytocin 10 IU or syntometrine 1 ampoule (5 mL). All participants had standard management of PPH (rubbing the uterus, commencing intravenous infusion, administering oxytocics, delivering the placenta if undelivered and emptying the bladder). Trial tablets (misoprostol 200 mcg or placebo) were administered: 1 orally and 2 sublingually.
Outcomes	Primary outcome: additional blood loss after enrolment. Secondary outcomes: frequency and severity of side effects, additional blood loss of 500 mL or more after enrolment, clinical complications (blood transfusion, hysterectomy) and haemoglobin level at 12 to 24 hours after delivery.
Notes	Blinding may have been compromised by non‐identical placebos.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Next in a series of randomised treatment packs in opaque envelopes containing misoprostol 3 200 Ag or placebo tablets.
Allocation concealment (selection bias)	Low risk	The randomisation code was broken only after entry and checking of data. An independent data monitor reviewed the data collected from the first 80 women and recommended that the study continue until complete recruitment.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Although this is a double‐blind trial, the authors indicated that the tablets were similar in size and colour but not in shape. Efforts to obtain identical placebo tablets were unsuccessful. Although no account indicated that the midwife caught sight of the tablet, this is not a sufficient guarantee of adequate blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No withdrawals after enrolment were reported, and all outcomes were analysed according to the allocated study group.
Selective reporting (reporting bias)	Unclear risk	No prior publication of protocol.
Other bias	Unclear risk	Outcome measure of blood loss may have included blood and other liquids collected during delivery.