Methods |
Sequentially‐numbered, opaque envelopes. |
Participants |
695 women in whom the decision has been made to induce labour with dinoprostone regardless of membrane and cervical status. Women with previous CS, twins and breech presentation were excluded. |
Interventions |
Titrated oral misoprostol versus vaginal dinoprostone 2 mg. Oral misoprostol was administered as solution (200 mcg tablet dissolved in 200 mL of water). Initial 2‐3 doses were 20 mcg increased to 40 mcg every 2 hours. Further doses were not given if contractions were judged to be clinically adequate.
Vaginal dinoprostone was given as a 2 mg gel followed by another dose 6 hours later.
In both groups oxytocin was started if there was no response after 24 hours. |
Outcomes |
Labour and birth outcomes.
Neonatal outcomes.
Maternal side effects. |
Notes |
5 women lost to follow‐up. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Envelopes were prepared using a computer‐ generated list of allocation. Allocations were balanced between groups using random block size (Betwwen two and six). |
Allocation concealment (selection bias) |
Low risk |
Sequentially‐numbered, opaque envelopes. |
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 |
High risk |
The study was not blinded. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
The study was not blinded. |