RecruitingPhase 4NCT07288021

Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

Sponsor

Bnai Zion Medical Center

Enrollment

200 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Labor, Induced

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a drug called Topical Analgesia with Lidocaine-Prilocaine cream for people with labor, induced. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTopical 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.

OTHERPlacebo

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.