United Kingdom 2000.
Methods | Random allocation by sealed, opaque, consecutively‐numbered envelopes. No blinding of outcome assessments. | |
Participants | 1000 women delivering vaginally, in London, UK. Women with a history of asthma, planned caesarean section and water birth were excluded. | |
Interventions | Misoprostol group: 500 mcg misoprostol orally after baby delivered and cord clamped. Uterotonic group: this group was given uterotonics at delivery of anterior shoulder. The choice of uterotonics varied according to the hospital policy for different groups of women. Women at high risk of haemorrhage received ergometrine (2%), those with hypertension received oxytocin (18%). All others received ergometrine‐oxytocin (80%). |
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Outcomes | Blood loss, side‐effects. Measurement of blood loss: clinical estimation by the midwives. | |
Notes | Management of third stage: 'active': cord traction with signs of separation, oxytocics at anterior shoulder delivery. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer generated block randomization." |
Allocation concealment (selection bias) | Low risk | "opaque, sequentially numbered sealed envelopes." |
Blinding (performance bias and detection bias) All outcomes | High risk | Open trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No mention of postrandomisation exclusions or protocol violations. |
Selective reporting (reporting bias) | Low risk | Primary outcomes of the review have been reported. |
Other bias | Low risk | Both groups were comparable at entry to the trial. |