Pain Control for Cervical Ripening Balloon

Purpose

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.

Condition

  • Labor Induction

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Topical lidocaine
  • Drug: topical vaginal application lidocaine gel
    Application of topical vaginal lidocaine prior to cervical balloon ripening
No Intervention
Standard of care

Recruiting Locations

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Sarah Little, MD
slittl10@bidmc.harvard.edu

More Details

Status
Recruiting
Sponsor
Beth Israel Deaconess Medical Center

Study Contact

Sarah Little, MD
6176677000
slittl10@bidmc.harvard.edu