WHO 1999.
Methods | Random allocation sequence, generated centrally. Sealed and numbered identical treatment packs taken consecutively from a dispenser. Double‐blinded, placebo controlled pilot trial. | |
Participants | 597 women after delivery in Khon Kaen, Thailand and Johannesburg, South Africa. Risk status not stated. Exclusion criteria: asthma, other severe chronic allergic condition, if delivery considered an abortion, planned caesarean section, not willing or able to give informed consent. |
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Interventions | Misoprostol 600 mcg orally vs misoprostol 400 mcg orally vs oxytocin 10 IU IV. | |
Outcomes | Shivering, pyrexia, side‐effects, blood loss from delivery to transferal of mother to postnatal care. Measurement of blood loss: collected blood poured in standard measuring jar. Linen not weighed. Small gauze swabs soaked with blood put into measuring jar and included in measurement. |
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Notes | Management of third stage: uterotonics, clamping and cutting of cord immediately after delivery, fundal or suprapubic pressure with cord traction after signs of placental separation. | |
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 | Sealed and numbered identical treatment packs taken consecutively from a dispenser. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double blinded using double placebos. |
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 because her tablets could not be located, and 1 woman in the 400 mcg group was excluded because of an emergency caesarean section. |
Selective reporting (reporting bias) | Low risk | Primary outcomes of the review were reported. |
Other bias | Low risk | The groups were comparable at the trial entry and at delivery except for low birthweight, which was higher in the misoprostol 600 mch group. |