| Methods |
2‐arm controlled randomised trial |
| Participants |
193 women were randomised in a hospital setting in UK. 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 induction or augmentation of labour or instrumental delivery, or those with grand multiparity (not defined), malpresentation, multiple pregnancy, previous caesarean, previous PPH, APH, hypertension in pregnancy, intrauterine death, PROM, cervical lacerations or third degree perineal tears. |
| Interventions |
No treatment versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); change in Hb; third stage duration (minutes). |
| 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 |
Randomly allocated using standard randomisation tables. |
| 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 |
High risk |
Investigators appraised blood loss by the estimation of attending physicians. |
| 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 |
Low risk |
The study was conducted without external funding. |
