Ireland
--:--IST
Latest
Clinical Trials in Israel / NCT07288021
Recruiting Phase 4

Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

NCT07288021 · tracked via the Priya Life Science Israel tracker
Phase
Phase 4
Started
2024-02-05
Last updated
2025-12-17

Condition(s) studied

Labor, Induced

Investigational drug(s) / intervention(s)

Topical Analgesia with Lidocaine-Prilocaine creamPlacebo

Topical Analgesia with Lidocaine-Prilocaine cream: patients allocated to \'EMLA\' arm will receive topical analgesia cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made to allow for maximal analgesic affect.

Placebo: patients allocated to \'Placebo\' arm will receive lubrication with placebo cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women scheduled for labor induction with balloon catheter. * 18 years of age or older. * Singleton pregnancy with a cephalic presentation. * ≥ 34 completed gestational weeks. * Does not participate in any other trial that might affect maternal or fetal/neonatal outcomes. * No contraindication for vaginal delivery Exclusion Criteria: * Unable or unwilling to provide and sign informed consent forms. * Known sensitivity to EMLA or placebo substance. * Known vulvodynia or vaginismus - rendering vaginal examination not possible. * Any chronic pain syndrome

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Bnai Zion Medical Center Haifa Israel Recruiting

More Bnai Zion Medical Center trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07288021 on ClinicalTrials.gov ↗ ← All trials in Israel