Methods |
2‐arm active‐controlled randomised trial |
Participants |
120 women were randomised in a hospital setting in Pakistan. The population comprised women of parity 4 or less, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with medical disorders, multiple pregnancy, instrumental births, stillbirths and over 42 weeks. |
Interventions |
400 mcg of Misoprostol administered sublingually versus 10 IU of Oxytocin administered IM |
Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; death; blood loss (mL); 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) |
Unclear risk |
1:1 simple randomisation but the sequence generation was not reported in sufficient detail. |
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 unclear. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
High risk |
Visual assessment of blood loss. |
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. |