| Methods |
Sequentially numbered opaque envelopes. |
| Participants |
178 women with intact membranes and unfavourable cervix (BS < 7). Each woman had either medical or obstetric complication requiring delivery. |
| Interventions |
Oral misoprostol 200 mcg and 1/2 tablet placebo vaginally or oral placebo tablet and a 1/2 tablet of 100 mcg misoprostol (50 mcg) vaginally. Doses were repeated every 6 hours (maximum 3) or until labour was established. |
| Outcomes |
Labour and delivery outcomes.
Neonatal outcomes. |
| Notes |
No postrandomisation exclusions. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Block randomisation‐no more details. |
| Allocation concealment (selection bias) |
Low risk |
Placebo controlled trial. |
| 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 |
Randomised double blinded study. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Randomised double blinded study. |
