| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
370 women were randomised in a hospital setting in Singapore. The population comprised women of unspecified parity, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing elective caesarean section, or those with multiple pregnancy, previous PPH, coagulopathy, coronary artery disease, hypertension or hypersensitivity/contraindications for the use of syntometrine or carbetocin. |
| Interventions |
100 mcg of carbetocin administered IM versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); third stage duration (minutes); nausea; vomiting; headache; shivering; abdominal pain. |
| Notes |
Contact with study authors for additional information: no. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was blocked and stratified by parity. The randomisation list with the allocation of the mode of intervention was forwarded from the Biostatistics Unit to the Department of Pharmacy at National University Hospital, where the purchased medications were kept. |
| Allocation concealment (selection bias) |
Low risk |
Used opaque packages made at pharmacy. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote "The identities of the medications were not known to the midwives, obstetricians and the participants. The medication codes were only broken following completion of the trial". |
| 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 by the visual estimation of attending obstetricians and midwives. |
| 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 protocol was registered 2 years after beginning recruitment (ClinicalTrial.gov NCT00499005). |
| 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 |
Low risk |
The study was supported by funding from the National Healthcare Group of Singapore (public funding). |
