Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2026-01-31
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Topical lidocaine
topical vaginal application lidocaine gel
Application of topical vaginal lidocaine prior to cervical balloon ripening
Standard of care
No interventions assigned to this group
Interventions
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topical vaginal application lidocaine gel
Application of topical vaginal lidocaine prior to cervical balloon ripening
Eligibility Criteria
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Inclusion Criteria
* Gestational age ≥37 weeks
* Viable pregnancy
* Intact membranes
* English speaking
* Interested in cervical ripening balloon placement
* Able to provide consent
Exclusion Criteria
* Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural)
* Known uterine or cervical anomalies
18 Years
FEMALE
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Sarah Little
Associate Professor
Central Contacts
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Other Identifiers
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2025P000734
Identifier Type: -
Identifier Source: org_study_id
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