Dansereau 1999

Methods	2‐arm active‐controlled double‐blinded randomised trial.
Participants	Between February 1992 and December 1994, 694 parturients were randomised in a hospital setting in Canada. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised parturients undergoing general anaesthesia or requiring a classical uterine incision, or those with heart disease, chronic hypertension requiring treatment, liver, renal, or endocrine disorders, coagulopathy, placenta praevia or placental abruption.
Interventions	100 mcg of carbetocin administered by an intravenous bolus (n = 348) versus 25 IU of oxytocin administered by an intravenous bolus plus infusion (n = 346).
Outcomes	The study recorded the following outcomes: additional uterotonics, transfusion, change in Hb level, nausea, vomiting, headache, shivering, abdominal pain.
Notes	Contact with study authors for additional information: yes. Additional data from authors: yes.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Treatment was allocated by a computer‐generated randomisation code, stratified by centre and with use of random blocks of 2.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not reported.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"All physicians and nurses involved, all investigators and their staff, and all sponsor representatives were kept blinded to the treatment codes at all times."
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outcome data (attrition bias) All outcomes	Low risk	"Informed consent was obtained from 694 patients. 35 patients were withdrawn from the study before they received study drug, leaving a total of 659 patients who received [the] study drug and were included in the safety analysis." Major protocol violations.
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	High risk	The study was supported by funding from Ferring Pharmaceuticals.