Labor Induction
Conditions
Keywords
cervical ripening, cervical balloon
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.
Interventions
DRUGtopical vaginal application lidocaine gel
Application of topical vaginal lidocaine prior to cervical balloon ripening
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTSarah Little, MD
Outcome results
None listed