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

• Published in: BJOG : an international journal of obstetrics and gynaecology 2019-08, Vol.126 (9), p.1148-1155
• Main Authors: Wallström, T, Strandberg, M, Gemzell‐Danielsson, K, Pilo, C, Jarnbert‐Pettersson, H, Friman‐Mathiasson, M, Wiberg‐Itzel, E
• Format: Article
• Language: English
• Subjects: Administration, Intravaginal; Administration, Oral; Adult; Apgar Score; Caesarean section; Cardiotocography - statistics & numerical data; Childbirth & labor; Delayed-Action Preparations; Delivery, Obstetric - statistics & numerical data; Evidence-based medicine; Female; Fetuses; Folkhälsovetenskap, global hälsa och socialmedicin; Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi; Gestation; Hemorrhage; Humans; Hälsovetenskap; Induced labor; induction of labour; Infant, Newborn; Klinisk medicin; Labor, Induced - methods; Medicin och hälsovetenskap; Misoprostol; Misoprostol - administration & dosage; Neonates; Oral administration; oral solution of misoprostol; Oxytocics - administration & dosage; Parity; Postpartum; Pregnancy; Reproduktionsmedicin och gynekologi; slow‐release vaginal insert of misoprostol; Sweden; Terbutaline; Term Birth - drug effects; Time Factors; Treatment Outcome; Vagina; VD24; Womens health
• ISSN: 1470-0328; 1471-0528; 1471-0528
• DOI: 10.1111/1471-0528.15796

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