| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
200 women were randomised in a hospital setting in India. The population comprised women of parity 3 or less, either singleton or multiple pregnancy, at high risk for PPH, who delivered by both elective or emergency caesarean. Exclusion criteria were not specified. |
| Interventions |
600 mcg of misoprostol administered rectally versus 10 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: additional uterotonics; transfusion; death; change in Hb; nausea; vomiting; hypertension; 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 |
The patients were randomised in 2 groups using random number table generated online (http://www.graphpad.com/quickcalcs/randomize1/). |
| 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 |
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 |
Low risk |
No funding was sought for this study. |
