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. 2012 Aug 15;2012(8):CD000494. doi: 10.1002/14651858.CD000494.pub4

Canada 2002.

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.