MISODEL (misoprostol), uterotonic prostaglandin

Clinical benefit insufficient in Induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated.

• MISODEL has Marketing Authorisation for
• Induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated.
• In a double-blind study of MISODEL versus PROPESS (vaginal delivery system releasing 10 mg of dinoprostone, prostasglandin E2), the interval between the initiation of treatment and delivery (primary endpoint) was shorter in the MISODEL group (median: 21.5 hours) than in the PROPESS group (median: 32.6 hours, p < 0.001). This study demonstrated that MISODEL is not inferior to PROPESS in respect of the percentage of caesareans.Foetal and neonatal safety criteria should have been chosen as the primary efficacy endpoint.
• Taking into account the excessive effect of misoprostol on uterine activity at the dose contained in MISODEL (200 µg), without any advantage in terms of maternal and/or foetal morbidity in comparison with intravaginal administration of prostaglandin E2, MISODEL has no place in the therapeutic strategy.