Methods |
2‐arm active‐controlled double‐dummy randomised trial |
Participants |
50 women were randomised in a hospital setting in Nigeria. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised women with asthma or with hypersensitivity to prostaglandins. |
Interventions |
600 mcg of misoprostol administered rectally versus 20 IU of oxytocin administered by an IV infusion |
Outcomes |
The study recorded the following outcomes: nausea; vomiting; fever; 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) |
Low risk |
1:1 computer‐generated randomisation. |
Allocation concealment (selection bias) |
Low risk |
The pharmacy department provided the study drugs and placebos in unidentifiable form but the resident doctor was responsible for the patient’s allocation according to the randomisation table. |
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 |
Outcome assessors were blinded. |
Objective assessment of blood loss |
Low risk |
Investigators weighed the pads 4 hours postpartum for assessment of blood loss. |
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. |