Methods |
3‐arm active‐controlled randomised trial. |
Participants |
Between dates unspecified, 156 parturients were randomised in a hospital setting in Spain. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised parturients with comorbidities, refractory hypotension due to neuraxial blockage, vasoactive drugs needed to control haemodynamic issues or multiple pregnancy. |
Interventions |
100 mcg of carbetocin administered by an intravenous bolus (n = 52) versus 61 IU of oxytocin administered by an intravenous bolus plus infusion (n = 104). |
Outcomes |
The study recorded the following outcomes: additional uterotonics, nausea, vomiting, headache, shivering. |
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 |
Randomisation was achieved using a computer‐generated sequence. |
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 unclear. |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
Unclear risk |
Investigators evaluated blood loss by the estimation of delivery attendants, but blood loss data were not reported in a format way that could be extracted for the purpose of this review. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
The study authors did not mention any incomplete outcome data. |
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. |