| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
120 women were randomised in a hospital setting in Malaysia. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at high risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women younger than 18 years old, or those with cardiac disorder, hypertension requiring treatment, liver/renal/vascular/endocrine disorder (excluding gestational diabetes) or hypersensitivity to oxytocin 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; severe maternal morbidity: intensive care admissions; additional uterotonics; transfusion; manual removal of placenta; death; blood loss (mL); change in Hb; nausea; vomiting; hypertension; 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 |
Computer‐generated randomisation. |
| Allocation concealment (selection bias) |
Unclear risk |
Used sealed, sequentially‐numbered envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "The preparation and administration of the medication was carried out by midwives who were not involved in the management of the patient except for the drug administration". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss by "the gravimetric method" from immediately after drug administration. They used a digital scale (Soehnle, Venezia) for weight measurement. In order to minimise confounding by fluid absorbed into drapes, they collected blood with a new plastic sheet placed under the mother after delivery of the baby. They also weighed any gauzes, tampons and pads used in the first hour after delivery of the placenta, and subtracted the dry weights of these materials to calculate blood loss on the basis that 1 g is equivalent to 1 mL. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| 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 |
Unclear risk |
Source(s) of funding for the study were not reported. |
