Methods |
2‐arm active‐controlled randomised trial |
Participants |
60 women were randomised in a hospital setting in UK. The population comprised women of both nulliparous and multiparous, either singleton or multiple pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria were not specified. |
Interventions |
10 IU of oxytocin administered by an IV bolus versus 400 mcg of misoprostol administered orally |
Outcomes |
The study recorded the following outcomes: PPH at 1000; additional uterotonics; transfusion; blood loss (mL; change in Hb; vomiting; shivering. |
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) |
Unclear risk |
Sequence generation was not reported. |
Allocation concealment (selection bias) |
Low risk |
Randomisation was performed using sealed opaque envelopes |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
High risk |
Investigators appraised intra‐operative blood loss by the estimation of attending physicians, and by measurement of preoperative and postoperative Hb concentration and hematocrit. |
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. |