| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
200 women were randomised in a hospital setting in India. The population comprised women of parity 4 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing caesarean section, or those with cardiac disorder in pregnancy, uterine tumour in pregnancy, secondary PPH, grand multiparity (not defined), multiple pregnancy, polyhydramnios, anaemia, coagulopathy, antepartum haemorrhage, previous PPH, prolonged labour, precipitate labour or known allergic or hypersensitivity reaction to prostaglandins. |
| Interventions |
10 IU of oxytocin administered by an IV infusion versus 800 mcg of misoprostol administered rectally |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; blood loss (mL); diarrhoea; nausea; 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 |
Used simple random sampling. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Study participants and caregivers were not blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Unclear risk |
Methods of appraising 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. |
