Abstract
PurposeTo provide real-world evidence using misoprostol vaginal insert (MVI) for induction of labor in nulliparous and parous women at two German Level I Centers in a prospective observational study.MethodsBetween 1 August 2014 and 1 October 2015, eligible pregnant women (≥ 36 + 0 weeks of gestation) requiring labor induction were treated with MVI. Endpoints included time to and mode of delivery rates of tocolysis use, tachysystole, uterine hypertonus or uterine hyperstimulation syndrome and newborn outcomes.ResultsOf the 354 women enrolled, 68.9% (244/354) achieved vaginal delivery (nulliparous, 139/232 [59.9%]; parous 105/122 [86.1%]; p < 0.001). Median time from MVI administration to vaginal delivery was 14.0 h (nulliparous, 14.5 h; parous, 11.9 h; p < 0.001). A total of 205/244 (84.0%) and 228/244 (93.4%) women achieved a vaginal delivery within 24 h and 30 h, respectively. The most common indications for cesarean delivery were pathologic cardiotocography (nulliparous, 41/232 [17.4%]; parous, 13/122 [10.7%]; p = 0.081) and arrested labor (dilation or descent; nulliparous, 45/232 [19.4%], parous, 3/122 [2.5%]; p ≤ 0.001). A total of 24.3% of women experienced uterine tachysystole and 9.6% experienced uterine tachysystole with fetal heart rate involvement, neither of which were significantly different for nulliparous and parous women. In total, 42/345 (12.2%) of the neonates had an arterial pH < 7.15 and 12/345 3.5% had a 5-min Apgar score ≤ 7.ConclusionWhen clinically indicated, MVI was efficient and safe for induction of labor in women with an unfavorable cervix. Women, however, should be counseled regarding the risk of uterine tachysystole prior to labor induction with MVI.
Highlights
Pregnancy is uncomplicated for the majority of women and progresses to term gestation and spontaneous labor without the need for intervention
*Chi-squared test for nominal data (%). This prospective clinical observational study confirmed the efficacy of Misoprostol vaginal insert (MVI) in both nulliparous and parous women who all had medical reasons for induction of labor, such as being post-term (> 40 + 0 weeks of gestation) diabetes, or hypertension
Another study by Bolla et al [16] that included 200 women who received MVI had a mean time from start of induction to vaginal delivery of approximately 17 h and 45 min
Summary
Pregnancy is uncomplicated for the majority of women and progresses to term gestation and spontaneous labor without the need for intervention. Misoprostol vaginal insert (MVI; Misodel®/Mysodelle®/ Myspess®, Ferring Pharmaceuticals) has been developed to provide continuous controlled-release of low-dose misoprostol, 7 μg/h over a period of 24 h [5], in an easy-touse application for cervical ripening and labor induction, and is combined with an integral retrieval system to allow the insert to be and quickly removed at the end of the dosing period once onset of active labor is achieved or if an adverse event occurs. Compared with dinoprostone (prostaglandin E2, PGE2), misoprostol has shown enhanced uterine contractility effects [7,8,9], which offer advantages in terms of shorter time interval to delivery and increases the risk for uterine tachysystole [7, 10, 11]. When compared with the dinoprostone vaginal insert (DVI; C ervidil®/Propess®, Ferring Pharmaceuticals) MVI provided a shorter time to vaginal delivery and comparable overall incidence of maternal and neonatal adverse events [7]
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