Methods |
Random‐number scheme generated by computer. Allocation concealment by opening the next sequentially‐numbered, sealed, opaque envelope. The study was not blinded. Power calculation is reported. |
Participants |
450 women delivering vaginally at Holy Family hospital, Techiman, Ghana. Women at both high and low risk for postpartum haemorrhage were included. |
Interventions |
Misoprostol 800 mcg orally vs oxytocin 10 IU IM. |
Outcomes |
Primary outcome: change in haemoglobin concentration, other measures of blood loss, side‐effects. Blood loss was estimated. |
Notes |
Management of the third stage: 'active', no further details. No loss to follow‐up. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"random, computer‐generated assignment." |
Allocation concealment (selection bias) |
Low risk |
"sequentially numbered, opaque, sealed envelope." |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
The study was not blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Analysis was intent‐to‐treat. No loss to follow‐up and exclusion after randomisation was reported. |
Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review have been reported. |
Other bias |
Low risk |
"There was no difference between the groups regarding baseline characteristics or risk factors for postpartum haemorrhage." |