A randomised trial comparing low dose vaginal misoprostol and dinoprostone for labour induction.

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.