| Methods |
2‐arm active‐controlled double‐dummy randomised trial |
| Participants |
380 women were randomised in a hospital setting in Egypt. The population comprised women of any parity, either singleton or multiple pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised women 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 IV infusion versus 100 mcg of carbetocin administered by an IV bolus |
| Outcomes |
The study recorded the following outcomes: severe maternal morbidity: additional uterotonics; transfusion; death; change in Hb; 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 |
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 |
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 appraised blood loss quote: "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. |
