Maternal and Neonatal Outcomes Following Labor Induction With a Dinoprostone Vaginal Insert in Pregnancies With Prelabor Rupture of Membranes: A Retrospective Observational Study

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Abstract
Background:The safety and efficacy of the dinoprostone vaginal insert for labor induction in women with prelabor rupture of membranes (PROM) remains uncertain. This study compared clinical outcomes between women with PROM and those with intact membranes.Methods:In this single-centre retrospective study, singleton pregnancies at ≥37 weeks of gestation induced with a dinoprostone vaginal insert between January 2020 and June 2025 were categorized as PROM (n = 42) or controls (n = 84). Demographic characteristics, cervical status, labor characteristics, delivery mode, maternal complications, as well as neonatal outcomes were analyzed using the t-test or Mann-Whitney U test for continuous variables and the chi-square or Fisher’s exact test for categorical variables, with a significance level of α = 0.05. The study was approved by the institutional ethics committee (Approval No.: 2026/6295; Application ID: 29133).Results:Gestational age at delivery was significantly lower in the PROM group than in the control group (37.70 ± 1.17 vs. 39.54 ± 1.39 weeks; p < 0.001). Although pre-induction cervical dilatation was greater in the PROM group, post-induction cervical dilatation and cervical effacement were significantly lower than those in the control group (both p < 0.001). The overall cesarean delivery rate was higher in the PROM group, primarily driven by an increased incidence of cesarean delivery due to fetal distress (35.7% vs. 16.7%; p = 0.008). Tachysystole was rare in both groups (0% vs. 1.2%; p = 0.478). No cases of postpartum hemorrhage or third-degree perineal lacerations occurred, and hemoglobin concentration and blood transfusion rates were comparable between groups. Neonates in the PROM group had significantly lower birth weights (2770.60 ± 447.30 g vs. 3321.20 ± 344.50 g; p < 0.001) and lower 5-minute Apgar scores (8.33 ± 1.00 vs. 9.25 ± 0.65; p < 0.001).Conclusions:Pregnancies complicated by PROM were associated with a reduced cervical response to dinoprostone, higher cesarean delivery rates, primarily due to fetal distress, and less favorable neonatal outcomes, whereas maternal safety outcomes appeared acceptable. Careful patient selection and close intrapartum monitoring are recommended when using dinoprostone for labor induction in women with PROM.

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