| Methods |
2‐arm placebo‐controlled randomised trial. |
| Participants |
1345 parturients were randomised in a hospital setting in Nigeria. The population comprised multiparous women, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered vaginally. Exclusion criteria comprised severe allergic conditions or asthma, age below 18 years, pyrexia above 38°C, or abortion of the pregnancy. |
| Interventions |
400 mcg of misoprostol administered sublingually plus 10 IU of oxytocin or 250 mcg to 500 mcg of ergometrine administered IM or by an intravenous bolus (n = 658) or IV bolus versus 10 IU of oxytocin or 250 mcg to 500 mcg of ergometrine administered IM or intravenously (n = 660). |
| Outcomes |
Could not include in the analysis as could not separate out the patients who received oxytocin from those who received ergometrine. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes, but data not provided separate for each drug used and could not be included in the meta‐analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Treatment was allocated in blocks of 6‐8 women by the research nurse, who used a computer‐generated randomisation sequence. |
| Allocation concealment (selection bias) |
Low risk |
The trial drugs were concealed in sealed, sequentially numbered opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Placebo was identical in shape, colour, size, and design. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinded. |
| Objective assessment of blood loss |
Low risk |
Blood collection was initiated as soon as possible after administration of the trial medication. A low‐profile plastic fracture bedpan was placed below the woman’s perineum to collect all subsequent blood loss for a period of 1 hour. Blood collected in the bedpan and all blood‐soaked small gauze swabs were emptied into a plastic measuring jar and the volume was measured. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No losses stated by authors but 27 women randomised were not included in the analysis for the primary outcome. |
| Selective reporting (reporting bias) |
Unclear risk |
No available protocol. |
| Intention to treat analysis |
Unclear risk |
27 women randomised were not included in the analysis for the primary outcome. |
| Funding source |
Low risk |
The trial was funded by theMedical Research Council of South Africa. |
