Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study

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.

Vaginal dinoprostone and misoprostol are equally safe in labour induction at term whereas dinoprostone is less efficacious for cervical ripening and shortening the time of labour

“…Our re-sults, however, showed different dynamics of the action of two compared drugs. Misoprostol has shown greater effectiveness compared to dinoprostone, which is consistent with studies by other authors [16][17][18]. Its higher efficiency is manifested by a significant shortening of the delivery time, both in the first and the second stage of labor [18].…”

“…In our studies, the mean time from vPG administration to the onset of labour differed significantly between primiparous and multiparous women. In the studies by Shmid et al [17], similar statistically significant relationships were obtained: 14.9 hours of primiparous women and 11.8 hours of multiparous women. According to the research literature, the use of dinorpostone compared to misoprostol is more often associated with the need to stimulate uterine contractions with oxytocin [16,20,21], although some authors report no significant differences between these two prostaglandins use [22].…”

Induction of labour in nulliparous women- quick or slow: a cohort study comparing slow-release vaginal insert with low-dose misoprostol oral tablets

“…The misoprostol slow-release vaginal insert has been assessed in five previous studies, also including multiparous women, that found consistent results compared with ours. Time from induction to delivery has been reported between 14.5-26.6 h and rates for CS was 7.5-40.1 [17][18][19][20][21][22][23]. Frequency of hyperstimulation was reported between 4.0 and 48.1%, leading to a higher CS rate and negative effects on neonatal outcomes.…”

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

“…Prostaglandins have been proven to induce labor whilst not increasing the rate of cesarean sections (CS) among women with unscarred uterus [7]. [8][9][10][11][12][13] even for women with an unfavourable cervix as to BISHOP scores [14], while reducing the need for oxytocin compared to dinoprostone vaginal insert or oral misoprostol [8,10,15].…”

“…Hyperstimulation syndrome requiring tocolysis is more common in women receiving MVI [8,10,11,14,16].…”