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Recruiting NCT07268118

Pain Control for Cervical Ripening Balloon

Phase II Interventional Labor Induction

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 vaginal application lidocaine gel.
Who it may be relevant to
Registry conditions: Labor Induction. 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
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Control Trial for Pain Control With Topical Lidocaine for Cervical Ripening Balloon Placement

Overview

No standard of care exists for pain management during cervical ripening balloon placement. The purpose of this study is to evaluate if vaginal topical lidocaine reduces pain related to cervical ripening balloon placement during induction of labor.

Interventions

  • Drug topical vaginal application lidocaine gel
    Application of topical vaginal lidocaine prior to cervical balloon ripening

Primary outcome measures

  • Patient-reported pain during cervical ripening balloon placement. [Time frame: Within 24 hours of cervical balloon ripening]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Gestational age ≥37 weeks
  • Viable pregnancy
  • Intact membranes
  • English speaking
  • Interested in cervical ripening balloon placement
  • Able to provide consent

Exclusion criteria

  • Allergy or sensitivity to lidocaine
  • Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural)
  • Known uterine or cervical anomalies

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
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT07268118 · 2025P000734

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗