Methods |
2‐arm active‐controlled double‐blinded randomised trial. |
Participants |
Between 12th June 2005 and 18th December 2006, 48 parturients were randomised in a hospital setting in Canada. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by emergency caesarean section. Exclusion criteria comprised parturients requiring general anaesthesia, or those with cardiac disease, hypertension or any condition predisposing to uterine atony and PPH, such as placenta praevia, multiple pregnancy, pre‐eclampsia, macrosomia, polyhydramnios, uterine fibroids, bleeding disorders, chorioamnionitis, previous uterine atony, previous PPH or allergy/hypersensitivity to oxytocin or ergot derivatives. |
Interventions |
250 mcg plus 20 IU of ergometrine plus oxytocin administered by an intravenous bolus (n = 24) versus 20 IU of oxytocin administered by an intravenous bolus plus infusion (n = 24). |
Outcomes |
The study recorded the following outcomes: additional uterotonics, transfusion, blood loss (mL), nausea, vomiting, hypertension, tachycardia. hypotension. |
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 achieved using a computer‐generated list of numbers. |
Allocation concealment (selection bias) |
Low risk |
Investigators used consecutively‐numbered opaque sealed packets or 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 |
High risk |
Investigators evaluated blood loss by measurement of haematocrit preoperatively and 48 hours postoperatively. |
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 |
Low risk |
The study was supported by funding from the institution of the authors. |