| Methods |
Random allocation by computer‐generated random numbers. Tablets kept in numbered, sealed, opaque containers. Non‐identical placebo tablets. Outcome assessments were blinded. |
| Participants |
550 low‐risk women after delivery at Coronation Hospital Johannesburg, South Africa.
Exclusion criteria: not noted. |
| Interventions |
Misoprostol 400 mcg rectally vs placebo. |
| Outcomes |
Blood loss greater than or equal to 1000 mL, use of additional uterotonics, spontaneous delivery of the placenta, third stage longer than or equal to 30 minutes, side‐effects.
Measurement of blood loss: blood collected in bedpan until 1 hour after delivery. Linens weighed. |
| Notes |
Management of third stage: placenta delivered either by cord traction or spontaneous expulsion. |
| 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 |
"sealed, opaque containers." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Non‐identical placebo. The blinding of the midwife administering the tablets was not possible, as identical placebo tablets were not available. Outcome assessments were blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Exclusions after randomisation: records for 4 allocations (all in placebo group), could not be traced. |
| Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review have been reported. |
| Other bias |
Low risk |
The 2 groups were well‐matched. |
