| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
200 women were randomised in a hospital setting in India. The population comprised women of any parity, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing emergency or elective caesarean section, or those with eclampsia, asthma, epilepsy, cardiac/kidney disorder or coagulopathy. |
| Interventions |
600 mcg of misoprostol administered orally versus 10 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; additional uterotonics; diarrhoea; nausea; vomiting; fever; shivering; abdominal pain. |
| 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 |
Randomly divided into 2 equal groups. |
| 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 |
Investigators appraised blood loss in mL, by collection with a calibrated plastic drape, after the drainage of amniotic fluid and delivery of the baby until the third stage of labour was completed. |
| 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. |
