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. (15th May 2019)

• Record Type: Journal Article
• Authors: Wallström, T; Strandberg, M; Gemzell‐Danielsson, K; Pilo, C; Jarnbert‐Pettersson, H; Friman‐Mathiasson, M; Wiberg‐Itzel, E
• Is Part Of: BJOG. Volume 126:Number 9(2019)
• Page Start: 1148
• Page End: 1155
• Publication Date: 2019-05-15
• Subjects: Caesarean section -- induction of labour -- oral solution of misoprostol -- slow‐release vaginal insert of misoprostol -- VD24; Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1111/1471-0528.15796
• Languages: English
• ISSNs: 1470-0328

Abstract

Abstract : 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 <7 at 5 minutes; pH < 7.10; postpartum haemorrhage (PPH) of >1000 ml; hyperstimulation; and women's delivery experience (VAS). Results: There was no difference in the time to vaginal delivery (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 < 0.01). Terbutaline (Bricanyl ® ) was used more often for hyperstimulation in the MVI group (22.7 versus 4.0%, P < 0.01). There was no difference in the numbers of children admitted to the neonatal intensive care unit (NICU). Conclusions: Vaginal delivery after induction of labour (IOL) with slow‐release misoprostol did not result in a shorter time from induction to vaginal delivery, compared with oral misoprostol solution, but was associated with a higher risk for hyperstimulation and fetal distress. There were no differences in mode of delivery or neonatal outcome. Tweetable abstract: IOL with MVI was similar to oral solution of misoprostol but hyperstimulation and fetal distress were more common. Tweetable abstract: IOL with MVI was similar to oral solution of misoprostol but hyperstimulation and fetal distress were more common.