Recruiting
Phase 2

Lidocaine

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT07268118

Conditions

Labor Induction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

topical vaginal application lidocaine gel

Study Details

Brief summary:

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.

Conditions

Labor Induction

Study ID

NCT07268118

Start date

May 13, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Topical lidocaine

no intervention: Standard of care

Interventions

topical vaginal application lidocaine gel

Application of topical vaginal lidocaine prior to cervical balloon ripening

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sarah Little, MD

6176677000slittl10@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Sarah Little, MD

slittl10@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • cervical ripening
  • cervical balloon

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-07-15.