| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
2040 women were randomised in a hospital setting in United Arab Emirates. The population comprised women of any parity, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing induction or augmentation of labour, caesarean section or instrumental delivery, or requiring general anaesthesia, epidural or diazepam, or those with antenatal hypertension (160/100 mmHg or more), hypertension on antihypertensive drugs, multiple pregnancy, cardiac disease or Hb of 90 g/L or less. |
| Interventions |
10 IU of oxytocin administered IM versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; transfusion; manual removal of placenta; vomiting; headache. |
| 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) |
Unclear risk |
Number code by the hospital pharmacist who alone was aware of the content of the ampoules. |
| Allocation concealment (selection bias) |
Low risk |
Participants were assigned an opaque sealed envelope. Each envelope carried the instruction to use a numbered vial of the study drug. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Study participants and caregivers were blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss "in the standard way" by measurement of blood and clots in a graduated jug, and by weighing swabs and linen. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "12 patients had to be excluded from the trial (oxytocin 5; ergometrine plus oxytocin 7) after randomisation because they no longer fulfilled the inclusion criteria (2 who required caesarean section and 10 who were delivered by forceps or ventouse (oxytocin, 4; Ergometrine plus oxytocin 6)." |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
High risk |
Those who withdrew from the study after randomisation were not included in the analysis. |
| Funding source |
Unclear risk |
Source(s) of funding for the study were not reported. |
