Methods |
2‐arm placebo‐controlled randomised trial. |
Participants |
Between dates unspecified, 214 parturients were randomised in a hospital setting in Korea. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at high risk for PPH, who delivered by caesarean (unspecified whether elective or emergency). Exclusion criteria were not specified. |
Interventions |
20 IU of oxytocin administered by an intravenous infusion (n = 118) versus 400 mcg plus 20 IU of misoprostol plus oxytocin administered rectally plus by an intravenous infusion (n = 96). |
Outcomes |
The study recorded the following outcomes: additional uterotonics, transfusion, change in Hb level, 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) |
Unclear risk |
Randomisation sequence generation was not reported. |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
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 |
Low risk |
Assessor blinding was not reported, but the use of placebo impeded knowledge of treatment allocations. |
Objective assessment of blood loss |
Unclear risk |
Methods of evaluating blood loss were not reported. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
The study authors did not mention any incomplete outcome data. |
Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
Intention to treat analysis |
Unclear risk |
The authors did not specify whether 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. |