Methods |
2‐arm active‐controlled double‐blinded randomised trial. |
Participants |
Between May 2009 and December 2009, 240 parturients were randomised in a hospital setting in Kuwait. The population comprised women of parity 5 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients less than 18 years old and those with known or suspected coagulopathy, grand multiparity (5 or more), uterine fibroids, polyhydramnios, multiple pregnancy, fetal macrosomia, severe anaemia, cervical tears or who required prophylactic oxytocin infusion. The presence of contraindications for the use of either Syntometrine or carbetocin that include pre‐existing hypertension, pre‐eclampsia, asthma, cardiac, renal or liver diseases, epilepsy, or history of hypersensitivity to Syntometrine or carbetocin. |
Interventions |
100 mcg of carbetocin administered intramuscularly (n = 120) versus 5 IU and 500 mcg of ergometrine plus oxytocin administered intramuscularly (n = 120). |
Outcomes |
The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, manual removal of placenta, blood loss (mL), change in Hb level, nausea, vomiting, hypertension, headache, abdominal pain. |
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 code prepared before the recruitment. |
Allocation concealment (selection bias) |
Low risk |
Investigators used sealed, consecutively‐numbered, opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
Study participants and caregivers were blinded to treatment allocations. |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
Objective assessment of blood loss |
Low risk |
Investigators evaluated blood loss by collection with a new plastic sheet placed under the mother following delivery of the placenta, and weighed (together with any gauzes, tampons and pads applied during the delivery) beforehand and 2 hours afterwards. A digital scale was used for weight measurement. |
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. |