China 2007.
Methods | Randomised, double‐blind, placebo‐controlled trial. | |
Participants | 355 women having a singleton pregnancy beyond 34 weeks of gestation, low risk for postpartum haemorrhage and a vaginal delivery. Women were considered low risk for postpartum haemorrhage if the index pregnancy was not complicated by presence of fibroids, polyhydramnios, fetal microsomia or any significant history of antepartum haemorrhage. Exclusion criteria included presence of contraindications for the use of either misoprostol or syntometrine, such as pre‐eclampsia, cardiac disease and asthma, and the presence of conditions requiring prophylactic oxytocin after delivery such as multiparity (parity >= 4) or presence of uterine fibroids. |
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Interventions | 400 mcg oral misoprostol versus 2 mL of syntometrine). | |
Outcomes | Change in Hb levels before and 48 hr after delivery Blood loss, duration of 3rd stage labour, use of additional oxytocics, use of blood transfusion, manual removal of placenta and side‐effects (nausea, vomiting, headache, diarrhoea, shivering, pyrexia) |
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Notes | Active management of third stage of labour. Blood loss was assessed by clinical estimation. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "table of computer generated random numbers." |
Allocation concealment (selection bias) | Low risk | "All women were asked to swallow the tablets directly from the opaque cup without looking at them." |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinded, placebo‐controlled. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 women were excluded from the analysis because of missing postdelivery haemoglobin level, all of them had postpartum blood loss of < 500 mL. Results from 355 women were analyzed on an intention‐to‐treat basis. |
Selective reporting (reporting bias) | Low risk | Primary outcomes of the review were reported. |
Other bias | Low risk | Baseline characteristics between the 2 groups are similar. |