Randomized Control Trial for Pain Control With Topical Lidocaine for Cervical Ripening Balloon Placement

NCT07268118 Phase 2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	110
Start date	2026-04
Completion	2027-06

Conditions

• Labor Induction

Interventions

• topical vaginal application lidocaine gel

Primary outcomes

• Patient-reported pain during cervical ripening balloon placement. — Within 24 hours of cervical balloon ripening
  Patient-reported pain score during cervical ripening balloon placement on a visual analog scale from 0 (no pain) to 10 (most pain).