| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
200 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 vaginal delivery. Exclusion criteria comprised women with placenta praevia, coagulopathy, pre‐eclampsia, cardiac/renal/liver disorders, epilepsy or known hypersensitivity to oxytocin or carbetocin. |
| Interventions |
100 mcg of carbetocin administered IM versus 5 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion.; blood loss (mL); change in Hb; third stage duration (minutes); nausea; vomiting; headache; tachycardia; 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 |
Participants were equally randomised using automated web‐based randomisation system. |
| Allocation concealment (selection bias) |
Unclear risk |
Only states that ensured allocation concealment with no further details. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported in sufficient detail even though the authors state it was double‐blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
High risk |
Investigators appraised blood loss by weighing swabs and using pictorial charts. |
| 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. |
