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Recruiting NCT07288021

Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

Phase IV Interventional Labor, Induced

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Topical Analgesia with Lidocaine-Prilocaine cream, Placebo.
Who it may be relevant to
Registry conditions: Labor, Induced. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug 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.
  • Other 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.

Primary outcome measures

  • Pain levels during insertion [Time frame: directly after application and insertion of balloon catheter.]
Secondary outcome measures (12)
  • analgesia while with balloon catheter [Time frame: 6-12 hours]
  • pain score during removal of catheter [Time frame: to be asked directly after removal, on a scale of 1-5.]
  • willingness to undergo cervical ripening with balloon catheter in the future [Time frame: to be asked directly after removal, on a scale of 1-5.]
  • analgesia during delivery [Time frame: From time of balloon insertion until the time of delivery, assessed up to 3 days and to be checked immediately after delivery.]
  • mode of delivery [Time frame: at delivery]
  • neonatal weight [Time frame: immediately after delivery]
  • APGAR [Appearance (color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing)] score [Time frame: up to 10 minutes after delivery]
  • cord blood gas [Time frame: up to 10 minutes after delivery]
  • Neonatal Intensive Care Unit (NICU) admission [Time frame: from delivery and up to 1 week]
  • neonatal infection [Time frame: 1st week after delivery]
  • duration of insertion procedure [Time frame: balloon insertion duration, estimated as up to 20 minutes]
  • difficulty of insertion [Time frame: to be reported by inserting doctor immediately after insertion procedure is completed, estimated up to 20 minutes.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Bnai Zion Medical Center — Haifa

Identifiers

NCT: NCT07288021 · 0061-23-BNZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗