Journal
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
Volume 115, Issue 10, Pages 1279-1288Publisher
WILEY-BLACKWELL
DOI: 10.1111/j.1471-0528.2008.01829.x
Keywords
cervical ripening; dinoprostone; induced labour; intravaginal; misoprostol
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Funding
- Alliance Pharmaceuticals Limited
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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.
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