| Methods |
Sequentially‐numbered, opaque envelopes. |
| Participants |
330 women with singleton pregnancies at over 32 weeks and with BS of < 6 (intact and ruptured membranes included). Women with more than 1 previous CS excluded ‐ 27 women had 1 previous CS. |
| Interventions |
3 groups, blinded to operator and patient. Misoprostol 25 mcg pv and 25 mcg po OR misoprostol 25 mcg pv and placebo po or misoprostol 25 mcg po with placebo pv. All doses given 4‐hourly up to 12 doses. |
| Outcomes |
Labour and delivery outcomes.
Neonatal outcomes.
Maternal side effects. |
| Notes |
The combined oral and vaginal group was not considered in this review. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Group allocation was predetermined in the pharmacy by means of a computer‐generated randomisation table |
| Allocation concealment (selection bias) |
Low risk |
Sequentially‐numbered, opaque envelopes |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data for all women reported. |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’ |
| Other bias |
Low risk |
None noted |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double blinded study. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double blinded study. |
