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Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
Sponsor: Bnai Zion Medical Center
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-02-05
Completion Date
2026-07-01
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Bnai Zion Medical Center
Haifa, Israel