A Randomized Controlled Trial to Compare Vaginal Dinoprostone Pessary with Intracervical Dinoprostone Gel for Pre-induction Cervical Ripening.

Abstract

Purpose: To compare safety and efficacy of vaginal dinoprostone pessary with intracervical dinoprostone gel for cervical ripening at term.

Methods: A hundred women with singleton pregnancies requiring labor induction with a Bishop score of ≤ 6 with intact membranes and no previous Cesarean Section (CS) were randomized to the pessary or gel group. All patients underwent assessment at baseline and every 8 h thereafter, along with the grading of discomfort noted on the visual analog scale (VAS). Pessary was kept for a maximum of 24 h, and the gel was inserted 8 hourly (maximum 3 doses).

Results: The pessary group needed fewer assessments during the induction process (2.24 ± 0.82 vs. 2.58 ± 0.61, p = 0.004^**). The change in Bishop's score after 8 h was significantly higher in the pessary group (2.69 ± 1.42 vs. 1.81 ± 1.26, p = 0.006^**). The pessary group had a considerably better VAS score 2.54 ± 1.13 vs. 3.18 ± 1.24, p = 0.004^**), depicting better tolerance of pessary. There was no statistically significant difference between both groups in terms of induction to delivery interval (IDI), mode of delivery, duration of 1st, 2nd, and 3rd stage of labor, type of rupture of membrane, need for intervention, and the indication for intervention. The rate of CS was higher in the gel group, though the difference was not statistically significant. The neonatal outcomes showed no difference.

Conclusion: Dinoprostone vaginal pessary is faster and better tolerated than cervical gel for cervical ripening at term. The IDI, mode of delivery, and maternal and neonatal outcomes were similar in pessary versus gel groups.