Amant 1999

Methods	2‐arm active‐controlled double‐dummy randomised trial.
Participants	Between 1st December 1997 and 20th April 1998, 213 parturients were randomised in a hospital setting in Belgium. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing caesarean section, or those with hypertensive disorders, gestational age less than 32 weeks, intrauterine fetal death, uterine malformations, inflammatory bowel disease, obliterative vascular or coronary disease, sepsis, allergy to prostaglandins or alkaloids.
Interventions	600 mcg of misoprostol administered orally (n = 105) versus 200 mcg of ergometrine administered by an intravenous bolus (n = 108).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonic, transfusion, manual removal of placenta, nausea, vomiting, headache, fever, shivering.
Notes	Contact with study authors for additional information: no. Additional data from authors: no.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Treatment was allocated by a computer‐generated list and randomisation in blocks.
Allocation concealment (selection bias)	Low risk	The study box contained either 2 capsules of misoprostol and an ampoule containing placebo, or 2 capsules with placebo and an ampoule containing methylergometrine. The study boxes and capsules were indistinguishable in the 2 groups.
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	Unclear risk	Methods of evaluating blood loss were not reported.
Incomplete outcome data (attrition bias) All outcomes	High risk	"213 women were enrolled in the study, but the data for 13 were excluded because a caesarean section was performed after randomisation (n = 3), or because no predelivery (n = 3) or postpartum (n = 7, short hospital stay) blood sample was taken."
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	High risk	Those who withdrew from the study after randomisation were not included in the analysis.
Funding source	Unclear risk	Source(s) of funding for the study were not reported.