| Methods |
2‐arm active‐controlled double‐dummy randomised trial |
| Participants |
360 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 requiring oxytocin infusion in the third stage, or those with pre‐eclampsia, cardiac disorder, asthma, grand multiparity (more than 3), fibroids or contraindications for the use of either misoprostol or syntometrine. |
| Interventions |
400 mcg of misoprostol administered orally 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; additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); change in Hb; diarrhoea; nausea; vomiting; hypertension; headache; fever; shivering; maternal satisfaction. |
| 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) |
Low risk |
The randomisation was based on a table of computer‐generated random numbers. |
| Allocation concealment (selection bias) |
Low risk |
Used consecutively‐numbered and sealed opaque packages. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The placebo was identical in size and colour but had a different shape to the misoprostol tablet. All women were asked to swallow the tablets directly from the opaque cup without looking at them. The identity of the active medication and placebo were concealed from the caregivers and the parturient." |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| 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 |
Quote: "5 women were excluded from the analysis because of missing post‐delivery haemoglobin level". |
| Selective reporting (reporting bias) |
High risk |
The protocol of the study was unavailable for verification, but not all of the outcomes projected by methodological descriptions were reported as results in the study report (cases of tachycardia and dizziness were omitted). |
| 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. |
