Efficacy and Safety of Misoprostol Vaginal Insert to Induce Labor beyond 40 + 0 Weeks of Gestation

Abstract

Objective: Misoprostol vaginal insert (MVI) is proven to induce labor by a continuously release of PGE1. Previous reports showed that MVI reduced induction to delivery time as well as active labor time but it also increased uterine tachysystole. Here we attempted to clarify whether MVI is safe and efficient for women with pregnancies >40 weeks in a single institute. Methods: This study was performed in Lutheran Hospital Bergisch Gladbach, Germany 2014-2019. A total of 304 women between 40 + 0 to 42 + 0 weeks underwent labor induction with MVI. Outcomes were: 1) maternal: time from insertion to delivery, interventions, mode of delivery, and uterine tachysystole, 2) neonatal: cord blood pH, APGAR scores, and admission to a neonatal clinic. This study ended unexpectedly due to the withdrawal of MVI (Misodel™) in September 2019. Results: 75.7% (n = 230) of women gave birth within 24 hours after MVI placement. 72.2% (n = 140) nulliparous women and 81.8% (n = 90) parous women delivered within 24 hours. In two cases emergency CS was required. 67.8% (n = 206) of women delivered vaginal. 2.3% (n = 7) of cord pH levels were below 7.10. 3.3% (n = 10) of newborns were transmitted to a neonatal clinic. Conclusion: MVI is an efficient method to induce labor for pregnant women beyond 40 + 0 weeks. However, considering various complications observed (uterine tachysystole and fetal distress leading to a high number of CS), we cannot universally advocate the use of MVI.