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Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

Study acronym: TOLERANCE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 17, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07288021
Lead Sponsor Bnai Zion Medical Center
Conditions
(from sponsor)		 Labor, Induced
Related terms Pain
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov