| Methods |
Random allocation by computer‐generated random sequence. Double‐blinded, placebo‐controlled trial. Tablets kept in numbered, sealed, opaque containers. Non‐identical placebo tablets. |
| Participants |
500 women after delivery at Coronation Hospital, Johannesburg, South Africa. No mention of risk status.
Exclusion criteria: oxytocin infusion in progress at the time of delivery, hypertension, diabetes, previous caesarean section delivery. |
| Interventions |
Misoprostol 400 mcg orally vs placebo. |
| Outcomes |
Blood loss greater than or equal to 1000 mL within first hour of birth, use of additional uterotonics, side‐effects, third stage 30 minutes or longer, manual removal of the placenta, blood transfusion.
Measurement of blood loss: blood and clots collected in bedpans and volume assessed. Linen weighed. |
| Notes |
Management of third stage: placenta removed by cord traction once firm uterine contraction diagnosed by palpation.
No withdrawals after randomisation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"computer‐generated random sequence." |
| Allocation concealment (selection bias) |
Low risk |
"numbered, opaque test tubes." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No exclusions after the randomisation. Intention‐to‐treat analysis. |
| Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review have been reported. |
| Other bias |
Low risk |
The groups were well‐matched. |
