drugset / Trial / NCT07288021

Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

NCT07288021

Phase 4 Recruiting 200 enrolled Bnai Zion Medical Center
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals. All participants are 18 or older, carrying a singleton in vertex position and in need of labor induction, are late-preterm or term (34 weeks gestation and onward) and without contraindication to vaginal delivery. Investigators seek to compare pain levels and patient satisfaction between two groups: Nulliparous patients, using EMLA or placebo (randomized, double blinded). Multiparous patients, EMLA or placebo.

Timeline

Start
2024-02-05
Primary completion
2026-02-28
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine-Prilocaine Unknown Topical

Indications

No indication recorded.