Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Labor, Induced

In brief

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 facts

Study ID

NCT07288021

Run by

Bnai Zion Medical Center

People needed

200

Starts

2024-02-05

Expected to finish

2026-07-01

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bnai Zion Medical Center — Haifa, Israel (enrolling)

Full record on ClinicalTrials.gov

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