Methods |
3‐arm placebo‐controlled randomised trial. |
Participants |
Between November 2009 and September 2011, 76 parturients were randomised in a hospital setting in Norway. 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 pre‐eclampsia, placenta praevia, placenta accreta, von Willebrand disease or other bleeding disorder or preoperative systolic arterial pressure less than 90 mmHg. |
Interventions |
5 IU of oxytocin administered by an intravenous bolus (n = 26) versus 100 mcg of carbetocin administered by an intravenous bolus (n = 25) versus placebo or control (n = 25). |
Outcomes |
The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, blood loss (mL), change in Hb level, headache. |
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 |
Treatment was allocated by a computer‐generated list of random numbers. The block size varied between 6 and 9, with stratification into 2 strata: BMI less than 30 and BMI of 30 or more. |
Allocation concealment (selection bias) |
Low risk |
Investigators used sequentially‐numbered, opaque, sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
The study was "double‐blinded": "to maintain blinding of the participants and investigators, the test medicine was delivered to the Department of Anaesthesiology in 10 mL syringes containing 5 mL of solution marked only with trial identification and randomisation numbers. The 10 mL syringes with the test medicines were prepared by a staff anaesthesiologist, who was otherwise uninvolved in the study." |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
Objective assessment of blood loss |
High risk |
Investigators evaluated blood loss with the following formula: (0.75 x height in inches x 50) plus (weight in pounds x 50) x ((predelivery haematocrit measurement ‐ postdelivery haematocrit measurement)/predelivery haematocrit measurement). |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
Selective reporting (reporting bias) |
Low risk |
The study report matches the study protocol that was registered (ClinicalTrials.gov NCT00977769). |
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 |
High risk |
The study was supported by funding from Ferring Pharmaceuticals. |