Methods |
2‐arm active‐controlled double‐dummy randomised trial. |
Participants |
Between October 2000 and February 2004, 622 parturients were randomised in a hospital setting in Canada. The population comprised women of unspecified parity, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing caesarean section, or those with placenta praevia, placental abruption, coagulopathy or unstable asthma. |
Interventions |
5 IU of oxytocin administered by an intravenous bolus (n = 311) versus 400 mcg of misoprostol administered orally (n = 311). |
Outcomes |
The study recorded the following outcomes: PPH at 1000, additional uterotonics, transfusion, manual removal of placenta, death, fever, shivering. |
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 |
Computer‐generated randomisation cards were produced. |
Allocation concealment (selection bias) |
Low risk |
Investigators used sealed, opaque, sequentially numbered envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
"The packages were prepared by the hospital pharmacy and their active drug unknown to the physicians and nurses." |
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 a combination of the visual estimation of attending physicians and measurement of blood volume in a kidney dish placed under the mother during the third stage of labour. |
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 Nova Scotia Health Research Foundation (public funding). |