| Methods |
Sequentially‐numbered, sealed envelopes stratified according to BS to the low or high group. |
| Participants |
206 women with intact membranes. |
| Interventions |
Either 50 mcg oral tablet with vaginal placebo or oral placebo with 50 mcg vaginal tablet.
Medication was given every 4 hours. |
| Outcomes |
Labour and delivery outcomes.
Uterine activity.
Neonatal outcomes.
Maternal side effects. |
| Notes |
No postrandomisation exclusions. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random number tables with randomization in blocks of four. |
| Allocation concealment (selection bias) |
Low risk |
Sequentially‐numbered, sealed envelopes stratified according to BS to the low or high group. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data for all women presented. |
| 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 induction method was concealed from all caregivers, participants, and investigators until data
analysis was completed. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The induction method was concealed from all caregivers, participants, and investigators until data
analysis was completed. |
