Pain Control for Cervical Ripening Balloon

NCT ID: NCT07268118

Last Updated: 2025-12-05

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

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Labor Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical lidocaine

Group Type EXPERIMENTAL

topical vaginal application lidocaine gel

Intervention Type DRUG

Application of topical vaginal lidocaine prior to cervical balloon ripening

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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topical vaginal application lidocaine gel

Application of topical vaginal lidocaine prior to cervical balloon ripening

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sarah Little

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sarah Little, MD

Role: CONTACT

6176677000

Other Identifiers

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2025P000734

Identifier Type: -

Identifier Source: org_study_id

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