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NCT Number: NCT07288021

Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

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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Key information

Conditions

Labor, Induced Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bnai Zion Medical Center

Haifa, 3339419, Israel

Location status: Recruiting

Location contact

Dafna Ben Yehuda Raz, MD

CONTACT

[email protected]

+97248359366

Dafna Ben Yehuda Raz, MD, OBGYN resident

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Analgesia with Lidocaine-Prilocaine cream

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

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.

Primary outcomes

  1. Pain levels during insertion

    Time frame: directly after application and insertion of balloon catheter.

    Pain levels during insertion of balloon catheter, as experienced by participant and ranked from 1 to 5 [1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)].

Secondary outcomes

  1. analgesia while with balloon catheter

    Time frame: 6-12 hours

    need for medical analgetics while with balloon catheter, to be checked by analgetics given by nursing staff while the patient is with the balloon cathether in place - a dichotomic variable (yes/no).

  2. pain score during removal of catheter

    Time frame: to be asked directly after removal, on a scale of 1-5.

    Pain levels during removal of balloon catheter, as experienced by participant and ranked from 1 to 5 [1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)].

  3. 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.

    willingness to undergo cervical ripening with balloon catheter in the future, on a scale of 1-5 (1- no, not under any circumstances; 2 - only if no other option exists; 3 - ambivalent; 4 - yes, but with concern; 5 - yes, no problem).

  4. 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.

    need and use for medical analgetics during the delivery process, including epidural, dolestion and NO.

  5. mode of delivery

    Time frame: at delivery

    mode of delivery - vaginal, operative vaginal of cesarean delivery

  6. neonatal weight

    Time frame: immediately after delivery

    neonatal weight in grams and percentile according to birth weight curves

  7. APGAR [Appearance (color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing)] score

    Time frame: up to 10 minutes after delivery

    APGAR scores at 1, 5 and 10 minutes of life of newborn, as given by midwife/doctor present at the time. higher values on this score reflect a better outcome.

  8. cord blood gas

    Time frame: up to 10 minutes after delivery

    cord blood gas levels, the first measurement taken after birth and up to 10 minutes after delivery.

  9. Neonatal Intensive Care Unit (NICU) admission

    Time frame: from delivery and up to 1 week

    NICU admission of newborn within first week of life

  10. neonatal infection

    Time frame: 1st week after delivery

    neonatal infection or suspicion of during birth hospitalization

  11. duration of insertion procedure

    Time frame: balloon insertion duration, estimated as up to 20 minutes

    duration of insertion of catheter procedure

  12. difficulty of insertion

    Time frame: to be reported by inserting doctor immediately after insertion procedure is completed, estimated up to 20 minutes.

    difficulty of insertion of catheter, as described by inserting physician

  13. obstetric trauma

    Time frame: up to an hour after delivery

    presence of, and degree, of perineal lacerations

Other outcomes

  1. Participant Satisfaction After Balloon Catheter Insertion

    Time frame: the patient is to be asked by inserting physician directly after insertion, on a scale of 1-5.

    satisfaction of participant from insertion of balloon catheter, as ranked by participant on a scale of 1-5 (1 - completely unhappy; 2 - slightly unhappy; 3 - ambivalent; 4 - mildly pleased; 5 - very pleased).

Study contacts

Contact information is provided by the study sponsor or research team.

Dafna Ben Yehuda Raz, MD, resident doctor

CONTACT

[email protected]

+97248359366

Inna Bleicher, MD, MFM specialist

CONTACT

[email protected]

+97248359366

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Acronym: TOLERANCE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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