| Methods |
2‐arm controlled randomised trial |
| Participants |
1429 women were randomised in a hospital setting in Ireland. The population comprised women of parity 5 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing caesarean section, vaginal breech or instrumental delivery, or those with hypertension, epidural anaesthesia, antepartum haemorrhage, placenta praevia, placental abruption, first stage of labour more than 15 hours, "quick" delivery or needing resuscitation. |
| Interventions |
500 mcg of ergometrine administered IV bolus versus No treatment |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); third stage duration (minutes); nausea; vomiting. Hypertension. Headache. Abdominal pain. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number tables were used. The first number was selected from the table and the numbers were then allocated in blocks of 100, following in sequence. |
| Allocation concealment (selection bias) |
Low risk |
Used numbered, sealed envelopes |
| 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 |
High risk |
Assessors were not blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
A sterile receiver was placed against the perineum to collect the blood lost and was measured. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No losses but dropouts for change in Hb. |
| 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 supported by public funding, or conducted without external funding. |
