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Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

NCT ID: NCT07288021

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Labor, Induced

Keywords

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induction balloon catheter EMLA Lidocaine/prilocaine pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Both creams (EMLA and placebo) are specially made in similar containers, labeled as A and B. Head of pharmacy in the study's medical center alone is aware which is EMLA or placebo. Both substances are of similar smell, texture and color.

Study Groups

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EMLA

Group Type EXPERIMENTAL

Topical Analgesia with Lidocaine-Prilocaine cream

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bnai Zion Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Dafna Ben Yehuda Raz, MD, resident doctor

Role: CONTACT

Phone: +97248359366

Email: [email protected]

Inna Bleicher, MD, MFM specialist

Role: CONTACT

Phone: +97248359366

Email: [email protected]

Facility Contacts

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Dafna Ben Yehuda Raz, MD

Role: primary

Other Identifiers

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0061-23-BNZ

Identifier Type: -

Identifier Source: org_study_id