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Ficha bibliográfica (sin autores) : | Induction of labour in nulliparous and multiparous women: A UK, multicentre, open-label study of intravaginal misoprostol in comparison with dinoprostone - BJOG: An International Journal of Obstetrics and Gynaecology - Vol. 115, 10 - p.1279-1288 |
Autores : | Calder, A.A.; Loughney, A.D.; Weir, C.J.; Barber, J.W. |
Año de publicación : | 2008 |
URL(s) : | https://www.scopus.com/inward/record.uri?eid=2-s2.… |
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Abstract (English) : | 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. © 2008 Alliance Pharmaceuticals Ltd. |
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Autor de este registro : | Import 26/11/2017 — 26 Nov 2017 |
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