Egypt 2009.
| Methods | Double blind, randomised, placebo‐controlled trial. | |
| Participants | 514 women with spontaneous normal delivery of a live, singleton neonate, and absence of any contraindications for misoprostol or oxytocin use were included. The women were excluded if they delivered by caesarean, had a history of antepartum haemorrhage or bleeding tendency, were diagnosed with hypertensive disorder with pregnancy or had the need for anticoagulants. |
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| Interventions | 800 mcg rectal misoprostol versus 5 IU of oxytocin in 5 mL lactated Ringer. | |
| Outcomes | The primary outcome was the number of patients estimated to have postpartum haemorrhage. Secondary outcomes were a haematocrit drop of 10% or more 24 hours postpartum; haemoglobin concentration 24 hours postpartum; changes in systolic and diastolic blood pressure; duration of the third stage of labour; need for manual removal of the placenta and/or blood transfusion; additional uterotonics, and nausea, shivering and fever (≥ 38 C) assessed 1 hour postpartum as the adverse effects of misoprostol. |
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| Notes | Active management of third stage of labour. Estimation of blood loss was not done on a quantitative basis; diagnosis of blood loss greater than 500 mL and the decision to apply further measures to control postpartum blood loss were based on a subjective estimation of blood loss by the obstetrician. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "computer generated random allocation system." |
| Allocation concealment (selection bias) | Low risk | "sealed, opaque, consecutively numbered and coded envelopes." |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinded. The randomisation code of data sheets was not broken until completion of the study. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up or exclusions reported. |
| Selective reporting (reporting bias) | Low risk | Primary outcomes of the review have been reported. |
| Other bias | Low risk | 2 groups were comparable at baseline. |