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Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

RecruitingPhase 4Ages 18 Years - anyFemaleBnai Zion Medical Center
NCT07288021 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Topical Analgesia with Lidocaine-Prilocaine cream
  • Placebo
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Where

1 site
Bnai Zion Medical Center
Haifa, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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