Induction of labour in nulliparous and multiparous women: a UK, multicentre, open‐label study of intravaginal misoprostol in comparison with dinoprostone
Аннотация:Objective To compare the efficacy and safety of a 25‐microgram vaginal tablet of misoprostol (APL202) with dinoprostone (3‐mg vaginal tablet) in cervical ripening and labour induction. Design A randomised, open‐label, noninferiority, comparative study in two maternal populations. Setting Eighteen NHS study centres across the UK. Population Nulliparous or multiparous women with a singleton pregnancy eligible for induction of labour. Methods Women were randomised to receive either misoprostol, initially 25 micrograms (50 micrograms in nulliparous women with Bishop score ≤4) followed by 25 micrograms after 4 and 8 hours, or dinoprostone, initially 3 mg followed by 3 mg after 6 hours. Clinical noninferiority of misoprostol was defined as an absolute difference between treatments of no more than 10% for the primary outcome. Main outcome measures The number of vaginal deliveries achieved within 24 hours of labour induction. Maternal and fetal safety outcomes. Results A total of 626 women were randomised to misoprostol ( n = 318) or dinoprostone ( n = 308) treatment. The rate of vaginal deliveries achieved within 24 hours of induction did not significantly differ between the misoprostol and dinoprostone (43 versus 47%; 3.74% difference, 95% CI −3.58 to 11.05, respectively) treatment groups. The treatments were generally comparable for other secondary efficacy measures. Maternal and fetal adverse events were similarly distributed across the misoprostol and dinoprostone groups. Conclusions Low‐dose misoprostol is efficacious in cervical ripening and labour induction and demonstrates a similar fetal and maternal safety profile to dinoprostone.
