Abstract
BackgroundMisoprostol vaginal insert for induction of labor has been recently reported to be superior to dinoprostone vaginal insert in a phase III trial, but has never been compared to vaginal misoprostol in another galenic form. The aim of this study was to compare misoprostol vaginal insert (MVI) with misoprostol vaginal tablets (MVT) for induction of labor in term pregnancies.MethodsIn this retrospective cohort study we compared 200 consecutive women induced with 200-μg misoprostol 24-h vaginal insert (Misodel®) with a historical control of 200 women induced with Misoprostol 25-μg vaginal tablets (Cytotec®) every 4-6 h. Main outcomes variables included induction-to-delivery interval, vaginal delivery within 24-h, incidence of tachysystole, mode of delivery, and neonatal outcome. A subanalysis in the MVI group was performed in order to identify predictive factors for tachysistole and vaginal delivery within 24 h.ResultsThe time from induction to vaginal delivery was 1048 ± 814 min in the MVI group and 1510 ± 1043 min in the MVT group (p < 0.001). Vaginal delivery within 24-h occurred in 127 (63.5%) patients of the MVI group and in 110 (55%) patients of the MVT group (p < 0.001). Tachysystole was more common in the MVI group (36% vs. 18%; p < 0.001). However, no significant predictors of uterine tachysystole in MVI group have been identified in crude and fully adjusted logistic regression models. Bishop score was the only predictor for vaginal delivery within 24 h (p < 0.001) in MVI group. Caesarean delivery rate (27% vs. 20%) and vaginal-operative deliveries (15.5% vs. 15.5%) did not differ significantly between the two groups. Neonatal outcomes were similar in both groups.ConclusionsMVI achieves a more vaginal delivery rate within 24 h and Tachysystole events compared to MVT. However, no differences in caesarean section, operative vaginal delivery, and neonatal outcomes are reported. No predictors of tachysistole after MVI administration have been identified. Bishop score and parity are the only predictors of vaginal delivery within 24 h after MVI administration.
Highlights
Misoprostol vaginal insert for induction of labor has been recently reported to be superior to dinoprostone vaginal insert in a phase III trial, but has never been compared to vaginal misoprostol in another galenic form
During the study interval a total of 400 women were included, 200 consecutive women induced with misoprostol vaginal insert (MVI) and 200 consecutive women induced with misoprostol vaginal tablets (MVT)
Uterine tachysystole was more frequent in the MVI group (36% n = 72 vs. 18% n = 36; p = 0.002)
Summary
Misoprostol vaginal insert for induction of labor has been recently reported to be superior to dinoprostone vaginal insert in a phase III trial, but has never been compared to vaginal misoprostol in another galenic form. An unfavourable cervix characterized by low cervical Bishop score decreases the success of labour induction and is associated with a higher incidence of caesarean sections (CS) [4,5,6,7]. In this context, the use of prostaglandins has proven to be more effective for cervical ripening in women with low Bishop score as compared to other commonly used methods (oxytocin, Foley catheter, amniotomy), but is associated with an increased rate of uterine tachysystole, hyperstimulation syndrome, and uterine rupture [8, 9]. The World Health Organization entered Misoprostol in the list of the essential drugs for obstetrical use and medical organisations such as the International Federation of Gynaecology and Obstetrics and the American College of Obstetrician and Gynaecologists recommended their use in pregnant women [2, 12,13,14,15]
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