Methods |
Random allocation from a central centre statistician using block randomisation for each participating centre. Consecutively‐numbered opaque, sealed packets for allocation concealment. No blinding of treatment or outcome assessments. |
Participants |
223 women with vaginal delivery from 3 hospitals in Toronto, Canada. Exclusion criteria: parity > 6, gestational age < 32 weeks, clotting disorder, anticoagulant therapy, history of postpartum haemorrhage, previous caesarean delivery. |
Interventions |
Misoprostol 400 mcg rectally after delivery vs oxytocin 5 IU IV or IM, or 10 IU IM given after delivery (sometimes given after placenta delivered). |
Outcomes |
Blood loss was captured by measuring change in measured haemoglobin. Other outcomes were duration of third stage, need for additional uterotonics, manual removal of placenta, blood transfusion, side‐effects. |
Notes |
No description of third stage management.
13 women excluded after randomisation secondary to having a caesarean section. 2 women lost to follow‐up. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"The coordinating centre statistician developed blocked randomization tables for each participating centre." |
Allocation concealment (selection bias) |
Low risk |
"consecutively numbered opaque, sealed packets that contained the group allocation and datasheets." |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
"the allocation was revealed to the caregivers and the women." |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
13 women were excluded after randomisation due to having caesarean sections. 2 women were lost to follow‐up early in the trial. Analysis of 223 women was on intention‐to‐treat basis. |
Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review were reported. |
Other bias |
Low risk |
There were no significant differences between the 2 groups. |