Pain Control for Cervical Ripening Balloon

Beth Israel Lahey Health

Status and phase: Not yet enrolling; Phase 2

Conditions: Labor Induction

Treatments: Drug: topical vaginal application lidocaine gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07268118

2025P000734

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Topical lidocaine

Experimental group

Treatment:

Drug: topical vaginal application lidocaine gel

Standard of care

No Intervention group