Elgafor 2013

Methods	2‐arm active‐controlled double‐dummy randomised trial.
Participants	Between February 2010 and October 2012, 380 parturients were randomised in a hospital setting in Egypt. 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 those with coagulopathy, coronary artery disease, hypertension, PPH due to causes other than uterine atony or hypersensitivity to carbetocin.
Interventions	400 mcg plus 20 IU of misoprostol plus oxytocin administered sublingually plus by an intravenous infusion (n = 190) versus 100 mcg of carbetocin administered by an intravenous bolus (n = 190).
Outcomes	The study recorded the following outcomes: morbidity, additional uterotonics, transfusion, death, blood loss (mL), change in Hb level, nausea, vomiting, headache, hypotension, fever, shivering.
Notes	Contact with study authors for additional information: yes. Additional data from authors: no.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was achieved using a computer‐generated random number sequence.
Allocation concealment (selection bias)	Low risk	Drugs were in pre‐prepared sealed and opaque packets.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Randomisation was done by the resident doctors immediately before transfer to theatre, whereas preparation of packets and confidential record maintenance was done by the labour room nursing staff... Caesarean delivery was performed by 4 senior obstetricians who were blinded to the allocation."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors were blinded to treatment allocations.
Objective assessment of blood loss	High risk	Investigators evaluated blood loss "in the usual way (visual estimation, number of used swabs and amount of aspirated blood)."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were collected completely from all randomised study participants.
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	Low risk	All those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised.
Funding source	Unclear risk	Source(s) of funding for the study were not reported.