Methods |
2‐arm placebo‐controlled randomised trial. |
Participants |
Between 16th December 1993 and 6th October 1994, 1000 parturients were randomised in a hospital setting in Sweden. 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 were not specified. |
Interventions |
10 IU of oxytocin administered by an intravenous bolus (n = 513) versus placebo or control (n = 487). |
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 (min). |
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 |
The randomisation was computer‐generated. |
Allocation concealment (selection bias) |
Low risk |
Ampoules were prepared at the hospital pharmacy and consecutively‐numbered. |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
"The content of the ampullas was unknown to mothers, midwives and doctors until the study was completed." |
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 measuring collected blood and adding what was estimated to have been absorbed by surgical cloths and tissues." |
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 County Council and County Health Authority Research and Development Foundation in the County of Jämtland, Sweden (public funding). |