India 2009d.
Methods | Randomised controlled trial. | |
Participants | 200 pregnant women at ≥ 32 weeks of gestation with either spontaneous or induced labour (what authors identified as low‐risk) were included. Exclusion criteria included grandmultipara (≥ 5), multiple gestation, < 32 weeks of gestation, HELLP syndrome, hydramnios, known blood coagulation disorders, history of asthma or drug allergy, heart disease, severe renal disease, epilepsy, hypertension and haemoglobin concentration < 8 g%. |
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Interventions | 400 mcg sublingual misoprostol versus 0.2 mg IM methylergometrine | |
Outcomes | Primary outcome measures were amount of blood loss in third stage of labour, postpartum haemorrhage (blood loss greater than 500 mL). Secondary outcome measures were change in haemoglobin concentration, need for additional oxytocic and side‐effects (nausea, temperature ≥ 38 C, shivering, pain in the abdomen and diarrhoea). |
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Notes | Active management of third stage of labour. Blood loss was estimated by measuring blood collected in the BRASS‐V drape, up to 1 hour after delivery of the baby, and blood soaked in gauze pieces. Blood loss in gauze pieces was calculated by subtracting weight of dry gauze from the weight of blood‐soaked gauze pieces. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated random number." |
Allocation concealment (selection bias) | Unclear risk | Unclear on how the allocation concealment was done. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not clear on blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up or exclusion postrandomisation were reported. |
Selective reporting (reporting bias) | Unclear risk | Not all of the primary outcomes of the review were reported. |
Other bias | Low risk | Demographic variables were equally distributed in the groups. |