| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
84 women were randomised in a hospital setting in Austria. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised women requiring general anaesthesia, or those with placenta praevia, placental abruption, multiple pregnancy, pre‐eclampsia, gestational diabetes, pre‐existing insulin‐dependent diabetes, cardiovascular/renal disorders, hypo‐/hyperthyroidism or women on cardiovascular system medications. |
| Interventions |
100 mcg of carbetocin administered by an IV bolus versus 5 IU of oxytocin administered by an IV bolus |
| Outcomes |
The study recorded the following outcomes: additional uterotonics change in Hb; nausea; headache. |
| 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 |
Randomisation was performed by a computer‐generated randomisation sequence 1:1 ratio—blocks of 10 without stratification. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "Study medication was double‐blinded to the clinical staff (obstetricians as well as anaesthesiologists) and the technicians performing the measurements". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Investigators did not appraise blood loss. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
After randomisation, investigators excluded 28 women from analysis for technical problems (n = 15), change to general anaesthesia (n = 9), recording artefacts (n = 3) and patient withdrawal (n = 1). |
| Selective reporting (reporting bias) |
Low risk |
The study report matches the study protocol that was registered (EudraCT 2007‐005498‐78). |
| Intention to treat analysis |
High risk |
Not all study participants were included in the analysis. |
| Funding source |
Low risk |
CNSystems Medizintechnik AG in Graz, Austria provided the Task Force® Monitor 3040i system used to measure haemodynamic parameters. No other external funding was required for the study. |
