Objective: To compare vaginal misoprostol with dinoprostone for induction of labour.
Design: Randomised multicentre trial.
Setting: Labour wards of one university hospital and two teaching hospitals.
Population: Six hundred and eighty-one women with indication for labour induction at >or=36 weeks of gestation, singleton pregnancy and no previous ceasarean section.
Methods: Misoprostol (25 mcg, hospital-prepared capsule) in the posterior vaginal fornix, every four hours, maximum three times daily or dinoprostone gel (1 mg) every four hours. Oxytocin was administered if necessary.
Main outcome measures: Primary: 'adverse neonatal outcome' (5-minute Apgar score <7 and/or umbilical cord pH <7.15). Secondary: labour duration, mode of delivery and patient satisfaction.
Results: Three hundred and forty-one women received misoprostol and 340 dinoprostone. The median induction-delivery interval was longer in the misoprostol group compared with the dinoprostone group (25 versus 19 hours, P= 0.008). The caesarean section rate was lower in the misoprostol group: 16.1%versus 21%, but this difference was not statistically significant RR = 0.8 (95% CI 0.6-1.04). 'Adverse neonatal outcome' was found to be similar in both groups: 21% in the misoprostol and 23% in the dinoprostone groups. Significantly fewer neonates were admitted to NICU in the misoprostol group compared with dinoprostone 19%versus 26% (RR = 0.7, 95% CI 0.5-0.98).
Conclusions: Misoprostol in this dosing regimen is a safe method of labour induction. NICU admission rates were lower in the misoprostol group. No difference could be detected in patient satisfaction between groups.