India 2009b.
Methods | Randomised, double‐blind, placebo‐controlled trial (2 arms of misoprostol and 1 arm of oxytocin). | |
Participants | 300 women with healthy singleton pregnancies in spontaneous or induced labour at term were included. Exclusion criteria included known hypersensitivity/contraindication to prostaglandins, intrauterine fetal demise, antepartum haemorrhage, multiple pregnancy, malpresentation, cardiac disease, Rhesus‐negative mother, hypertensive disorders, and severe anaemia (haemoglobin < 7 g/dL). |
|
Interventions | 400 mcg sublingual misoprostol, 600 mcg sublingual misoprostol versus 5 IU IV oxytocin. | |
Outcomes | Blood loss during the 3rd and 4th stage of labour, duration of 3rd stage of labour, need for additional oxytocics, need for blood transfusion and adverse effects of the drugs. | |
Notes | Active management of third stage of labour 1 hour after delivery, the preweighted, blood‐soaked linen‐saver sheet and preweighted sanitary pads were weighted to assess maternal blood loss. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated random numbers." |
Allocation concealment (selection bias) | Unclear risk | Unclear how the allocation concealment was done. |
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 were reported. |
Selective reporting (reporting bias) | Unclear risk | Not all of the primary outcomes of the review were reported. |
Other bias | Low risk | Baseline demographic and clinical characteristics of patients were similar among the groups. |