| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
100 women were randomised in a hospital setting in India. The population comprised women of parity 2 to 4, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with previous PPH, multiple pregnancy, previous caesarean, macrosomia, pre‐eclampsia, diabetes, cardiac/lung/bleeding/clotting disorders or taking anticoagulants. |
| Interventions |
10 IU of oxytocin administered by an IV bolus versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500. |
| 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) |
Low risk |
Study participants (patients) were divided by lottery system in the 2 groups, each group comprising of 50 patients. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High 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 |
Low risk |
Investigators appraised blood loss after the delivery of baby quote "by squeezing the soaked pads and quantifying the amount of blood clots in a kidney tray of standard size to be equal to 500 mL". |
| 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. |
