Efficacy and safety of Misoprostol vaginal insert to induce labor beyond 40 + 0 weeks of gestation

Abstract

IntroductionOne of the most common reasons for inducing labor are pregnancies beyond 40 + 0 weeks. Prostaglandins have been proven to induce labor whilst not increasing the rate of caesarean delivery. As a vaginal insert Misoprostol was available in Germany from 2014 to 2019. Studies show that Misoprostol vaginal insert (MVI) reduces induction to delivery time as well as active labor time. But it is also known to increase uterine tachysystole. This study aimed to clarify whether MVI is safe and efficient for women with pregnancies past 40 + 0 to 42 + 0 weeks since there is a lack of studies focussing on this particular group of women.MethodsThis single centre prospective cohort study was performed between December 2014 and September 2019 at a tertiary academic centre at the Presbyterian Hospital Bergisch Gladbach, Germany. A total of 304 women between 40 + 0 to 42 + 0 weeks of gestation have been induced to labor with MVI. MVI was placed in the posterior vaginal fornix to release to release 200 μg synthetic prostaglandin E1 in a controlled manner. Time from insertion of MVI to delivery was documented for each patient. In addition, we recorded all kinds of intervention, CTG alterations and fetal outcome. We recorded mode of delivery, the need of epidural anaesthesia as well as the rate of tocolysis to treat signs of fetal distress due to pathological heart rates. And thirdly we had an interest in fetal outcome reflected by cord blood pH-levels or admission to a neonatal clinic.Results75.7 % (n = 230) of women gave birth within 24 hours which means time from insertion to delivery. After MVI insertion 72.2 % (n = 140) nulliparous women and 81.8 % (n = 90) multiparous women gave birth within 24 hours. Subgroup analyses revealed that within 24 hours after removal of MVI 259 women out of 304 (85.2 %) delivered their babies. 67.8 % (n = 206) of women induced with MVI delivered vaginal. ConclusionMVI is an efficient and safe method to induce labor for women with pregnancies beyond 40 + 0 weeks. ISRCTN No. 14702259 date of registration: 21.08.2020URL: http://www.isrctn.com/ISRCTN14702259