Methods |
Random allocation sequence concealed until enrolment. Packs containing both active and placebo were made available after random allocation. It is not clear if the placebos are identical. No mention of blind outcome assessments. |
Participants |
400 women in active labour or undergoing induction of labour in Los Angeles, USA were enrolled. Women with multiple gestation, known coagulation disorders, contraindication to prostaglandin or oxytocin use, known initial haemoglobin below 7.0 mg/dL and an indication for caesarean section were excluded. |
Interventions |
Misoprostol 400 mcg rectally + placebo (2 mL saline) vs oxytocin 20 IU + placebo (lactose tablets). Oxytocin (and its placebo) was administered as IV infusion in 1 L of Ringer's lactate solution. |
Outcomes |
Blood loss (estimated and measured by weighing linen etc.), haematocrit, side‐effects. |
Notes |
Management of the third stage not mentioned. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"random number sequence." |
Allocation concealment (selection bias) |
Unclear risk |
Unclear on how the allocation concealment was done. |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Unclear if the blinding was not broken. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Exclusions after randomisation: 75/400 (18.75%), 73 had caesarean section during labour, 1 had Hb < 7.0 mg/dL and 1 was discharged home before delivery. |
Selective reporting (reporting bias) |
Unclear risk |
Not all of the primary outcomes of the review were reported. |
Other bias |
Low risk |
2 groups were comparable. |