| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
100 women were randomised in a hospital setting in India. The population comprised women of parity 4 or less, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with grand multiparity (not defined), rhesus negative blood group, cardiac disease, diabetes, bleeding disorder, precipitated labour, overdistended uterus, traumatic PPH, PROM/chorioamnionitis, intrauterine death, previous caesarean section/scar on uterus or inability to obtain the informed consent. |
| Interventions |
10 IU of oxytocin administered IM versus 200 mcg of ergometrine administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; additional uterotonics; transfusion; blood loss (mL); third stage duration (minutes); diarrhoea; nausea; vomiting; headache. |
| 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 |
Systematic random sampling method. |
| 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 |
Low risk |
Investigators appraised blood loss by collection with drapes that were weighed together with mops and clots, and by measurement of Hb concentration and haematocrit of a sample of venous blood before delivery and 24 hours after birth. A sample of venous blood before delivery and 24 hours after the birth was also collected, for Hb and haematocrit measurement quote: "as an objective index of blood loss". |
| 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. |
