Pain Control for Cervical Ripening Balloon

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT07268118
Phase
PHASE2
Status
Recruiting
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Conditions

  • Labor Induction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 5, 2025
Start date
May 13, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Topical lidocaine
  • No Intervention: Standard of care

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Sarah Little, MD
[email protected]

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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