Nigeria 2003.
Methods | Randomised double‐blind trial with identical looking double placebos. Randomisation schedule generated using random‐number tables. Allocation concealment achieved by using sealed opaque packets containing both active and the corresponding placebo medication. | |
Participants | 496 low‐risk women having vaginal births in 2 hospitals in Delta State, Nigeria. Women undergoing caesarean section and who had other risk factors for haemorrhage were excluded. | |
Interventions | Misoprostol 600 mcg in powder form dissolved in 50 mL water per os vs oxytocin 10 IU IM at delivery of anterior shoulder. | |
Outcomes | Blood loss, postdelivery haemoglobin, side‐effects. Blood loss estimated by the clinicians. | |
Notes | Management of third stage: controlled cord traction, no other details. No loss to follow‐up or postrandomisation exclusions reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "random number‐generated tables." |
Allocation concealment (selection bias) | Low risk | "opaque sealed packets containing a card indicating group allocation." |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up or postrandomisation exclusions reported. |
Selective reporting (reporting bias) | Unclear risk | Not all of the primary outcomes of the review were reported. |
Other bias | Low risk | There were no significant differences between 2 groups. |