Methods |
2‐arm active‐controlled randomised trial |
Participants |
144 women were randomised in a hospital setting in Panama. The population comprised women of parity 5 or more, a singleton pregnancy, at high risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing emergency caesarean section, or those with coagulopathy, unknown parity or known allergy to carbetocin. |
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: additional uterotonics; transfusion; manual removal of placenta; breastfeeding; nausea; vomiting; headache; shivering; abdominal pain. |
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) |
Unclear risk |
Sequence generation was not reported. |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
Unclear risk |
Methods of appraising blood loss were not reported. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
Selective reporting (reporting bias) |
High risk |
The protocol of the study was unavailable for verification, but not all of the outcomes projected by methodological descriptions were reported as results in the study report (cases of PPH were omitted). |
Intention to treat analysis |
High risk |
Not all study participants were included in the analysis. |
Funding source |
Low risk |
Ferring Pharmaceuticals donated carbetocin. No other external funding was required for the study. |