Methods |
"Pharmacy prepared and distributed the medication according to the schedule"; study described as double‐blind. |
Participants |
160 women requiring induction at term; 50 had ruptured membranes and 79 were nulliparous. |
Interventions |
Oral misoprostol 200 mcg or placebo as a single dose followed 12 hours later by iv oxytocin if not in labour. |
Outcomes |
Labour and birth outcomes.
Neonatal outcomes. |
Notes |
4 women were excluded after randomisation. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
The randomisation was performed using a computer‐generated random number table. |
Allocation concealment (selection bias) |
Unclear risk |
Method of allocation concealment was not described. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Other bias |
Unclear risk |
Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The study described as double‐blinded. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The study described as double‐blinded. |