| Methods |
Sequentially‐numbered, opaque envelopes. |
| Participants |
167 women at term with intact membranes who were unsuitable for amniotomy. |
| Interventions |
Oral or vaginal misoprostol, both 50 mcg 6‐hourly, max 8 doses. |
| Outcomes |
Labour and delivery outcomes.
Minimal neonatal outcomes.
Maternal side effects. |
| Notes |
7 women excluded. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Envelopes were prepared by the study pharmacist using random number tables with randomisation in blocks of four. No more details described. |
| Allocation concealment (selection bias) |
Low risk |
Sequentially numbered opaque envelope. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data for all women presented. |
| Selective reporting (reporting bias) |
Low risk |
Selective reporting not apparent. |
| Other bias |
Low risk |
None noted. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The study participants, attending staff and residents were unaware of the blocked randomisation and group assignment was concealed until the envelope was opened |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double blinded randomised controlled trial. |
