Pain Control for Cervical Ripening Balloon

Phase 2Not Yet RecruitingNCT07268118

Beth Israel Deaconess Medical Center110 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Labor Induction

Interventions

topical vaginal application lidocaine gelDRUG

Application of topical vaginal lidocaine prior to cervical balloon ripening

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient-reported pain during cervical ripening balloon placement.

Patient-reported pain score during cervical ripening balloon placement on a visual analog scale from 0 (no pain) to 10 (most pain).

Time frame: Within 24 hours of cervical balloon ripening

Central Contacts

Sarah Little, MD

CONTACT

6176677000 slittl10@bidmc.harvard.edu

Data from ClinicalTrials.gov

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