| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
991 women were randomised in a hospital setting in Hong Kong. The population comprised women of parity 3 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with medical conditions that precluded the use of ergometrine, such as pre‐eclampsia, cardiac disease or conditions that required prophylactic oxytocin infusion after delivery such as grand multiparity (4 or more) or presence of uterine fibroids. |
| Interventions |
500 mcg plus 5 IU of ergometrine plus oxytocin administered IM versus 10 IU of oxytocin administered by an IV bolus |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); change in Hb; nausea; vomiting; hypertension;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) |
Low risk |
Computer‐generated random number. |
| Allocation concealment (selection bias) |
Low risk |
Used sealed consecutively‐numbered opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The preparation and administration of the medication was carried out by a second midwife who was not involved in the management of the patient except for the drug administration. The medical attendant who delivered the baby was not informed of the type of oxytocics used." |
| 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 quote: "by measuring the amount of blood clots and weighing the towels and swabs used". |
| 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 |
Unclear risk |
Source(s) of funding for the study were not reported. |
