| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
200 women were randomised in a hospital setting in India. The population comprised women of nulliparous, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria were not specified. |
| Interventions |
600 mcg of misoprostol administered orally versus 200 mcg of ergometrine administered by an IV bolus |
| Outcomes |
The study recorded the following outcomes: PPH at 500; additional uterotonics; manual removal of placenta; third stage duration (minutes); diarrhoea; nausea; vomiting; headache; 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 |
Randomised in 1:1 ratio by random number sequence. |
| 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 |
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 |
Unclear risk |
Source(s) of funding for the study were not reported. |
