| Methods |
3‐arm active‐controlled double‐dummy randomised trial |
| Participants |
597 women were randomised in a hospital setting in South Africa and Thailand. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing elective caesarean section or abortion, or those with asthma, other severe chronic allergic conditions a contraindication to use of misoprostol or if they were not willing or able to give informed consent. |
| Interventions |
600 mcg or 400 mcg of misoprostol administered orally versus 10 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; death; blood loss (mL); diarrhoea; nausea; vomiting; fever; shivering. |
| 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 |
Random allocation sequence, generated centrally. |
| Allocation concealment (selection bias) |
Low risk |
The treatment packs were consecutively‐numbered and sealed. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The packs were identical in shape, colour, weight and feel. Each woman received an injection and 3 tablets. Thus, the trial was double‐blinded using double placebos". |
| 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 from the delivery of the baby until the mother was transferred to postnatal care. The collected blood was poured into a standard measuring jar provided by WHO for the purpose of volumetric measurement. Linen was not weighed but clots and small gauze swabs soaked with blood were included in the measurement. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Exclusion after randomisation: 8 women in the oxytocin group did not comply with treatment (6 had an emergency caesarean section, 1 was HIV positive and mistakenly excluded, 1 whose ampoule was not located). 1 woman in the 600 mcg group was excluded. |
| 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 funding from the WHO (public funding). Active and placebo medications, syringes and swabs were donated by Searle, Novartis Pharma AG and Becton Dickinson International. |
