| Methods |
2‐arm active‐controlled double‐dummy randomised trial |
| Participants |
180 women were randomised in a hospital setting in Egypt. The population comprised women of nulliparous, a singleton pregnancy, at high risk for PPH, who delivered by emergency caesarean section. Exclusion criteria comprised women undergoing elective caesarean section, vaginal delivery or general anaesthesia, or those who are multigravida, or with malpresentation, fetal anomalies, placenta praevia, diabetes, hypertension, pre‐eclampsia or cardiac disease. |
| Interventions |
100 mcg of carbetocin administered by an IV bolus versus 20 IU of oxytocin administered by an IV infusion |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; death; blood loss (mL;. change in Hb; headache; fever. |
| 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 |
Computer‐generated code. |
| Allocation concealment (selection bias) |
Low risk |
Used sealed, opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The study was quote: "double‐blinded": "a double dummy system for administration was used". |
| 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 |
Unclear risk |
180 women were included in the study, but 100 were excluded because 4 had congenital fetal anomalies, 7 cases had placenta praevia, 5 cases were diabetic, 8 had hypertension, 9 had pre‐eclampsia, 3 cases were cardiac, 28 cases needs general anaesthesia, 17 cases delivered vaginally and 19 cases delivered by elective caesarean section). It was unclear if these were excluded before or after randomisation. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
Unclear risk |
The authors did not specify whether 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. |
