Slow-release vaginal insert of misoprostol versus orally administrated solution of misoprostol for the induction of labour in primiparous term pregnant women: a randomised controlled trial

Autor: Hans Järnbert-Pettersson, Kristina Gemzell-Danielsson, M Friman-Mathiasson, M Strandberg, C Pilo, Tove Wallstrom, Eva Wiberg-Itzel
Rok vydání: 2019
Předmět:
Zdroj: BJOG : an international journal of obstetrics and gynaecology. 126(9)
ISSN: 1471-0528
Popis: OBJECTIVE To compare the World Health Organization (WHO) recommended orally administrated dosage of misoprostol (25 μg) with a vaginal slow-release (7 μg/hour) insert of misoprostol regarding time from induction to delivery and safety of the method. DESIGN Open label, Randomised controlled trial (RCT). SETTING Delivery ward at a secondary referral hospital in Stockholm, Sweden, from 1 October 2016 to 21 February 2018. POPULATION One hundred and ninety-six primiparous women with singletons in cephalic presentation at ≥37 weeks of gestation and with a Bishop score of ≤4. METHODS Women were randomised to an oral solution of misoprostol (Cytotec® n = 99) or vaginal slow-release misoprostol (Misodel® [MVI] n = 97). MAIN OUTCOME MEASURES Primary outcome: time from induction to vaginal delivery. SECONDARY OUTCOMES mode of delivery; proportion of vaginal deliveries within 24 hours (VD24); neonates with an Apgar score of 1000 ml; hyperstimulation; and women's delivery experience (VAS). RESULTS There was no difference in the time to delivery [corrected] (median 21.1 hours in the MVI group and 23.2 hours in the oral group; Kaplan-Mayer log rank P = 0.31). There was no difference regarding the proportion of VD24 (50.5 versus 55.7%, P = 0.16). Hyperstimulation with non-reassuring cardiotocography (CTG) was more common in the MVI group (14.4 versus 3.0%, P
Databáze: OpenAIRE