NCT07268118

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
13mo left

Started Apr 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

November 24, 2025

Last Update Submit

March 3, 2026

Conditions

Labor Induction

Keywords

cervical ripeningcervical balloon

Outcome Measures

Primary Outcomes (1)

  • 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).

    Within 24 hours of cervical balloon ripening

Study Arms (2)

Topical lidocaine

EXPERIMENTAL
Drug: topical vaginal application lidocaine gel

Standard of care

NO INTERVENTION

Interventions

topical vaginal application lidocaine gelDRUG

Application of topical vaginal lidocaine prior to cervical balloon ripening

Topical lidocaine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Gestational age ≥37 weeks
  • Viable pregnancy
  • Intact membranes
  • English speaking
  • Interested in cervical ripening balloon placement
  • Able to provide consent

You may not qualify if:

  • Allergy or sensitivity to lidocaine
  • Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural)
  • Known uterine or cervical anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Sarah Little, MD

CONTACT

6176677000slittl10@bidmc.harvard.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03