| Methods |
Sequentially‐numbered, opaque envelopes containing drug or placebo. |
| Participants |
103 women without complications at term with ruptured membranes. 43 were nulliparous. |
| Interventions |
Oral misoprostol 100 mcg or placebo 6‐hourly for 2 doses followed by dinoprostone gel 1 mg 6‐hourly until in labour. |
| Outcomes |
Labour and delivery outcomes.
Neonatal outcomes. |
| Notes |
7 postrandomisation exclusions. Placebo looked and tasted different to misoprostol. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation occurred by using computer generated numbers. |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate: Sequentially‐numbered, opaque envelopes containing drug or placebo. |
| 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 was double blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The study was double blinded. |
