Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT07268118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Control for Cervical Ripening Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported pain during cervical ripening balloon placement.', 'timeFrame': 'Within 24 hours of cervical balloon ripening', 'description': 'Patient-reported pain score during cervical ripening balloon placement on a visual analog scale from 0 (no pain) to 10 (most pain).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical ripening', 'cervical balloon'], 'conditions': ['Labor Induction']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Gestational age ≥37 weeks\n* Viable pregnancy\n* Intact membranes\n* English speaking\n* Interested in cervical ripening balloon placement\n* Able to provide consent\n\nExclusion Criteria:\n\n* Allergy or sensitivity to lidocaine\n* Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural)\n* Known uterine or cervical anomalies'}, 'identificationModule': {'nctId': 'NCT07268118', 'briefTitle': 'Pain Control for Cervical Ripening Balloon', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Randomized Control Trial for Pain Control With Topical Lidocaine for Cervical Ripening Balloon Placement', 'orgStudyIdInfo': {'id': '2025P000734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical lidocaine', 'interventionNames': ['Drug: topical vaginal application lidocaine gel']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care'}], 'interventions': [{'name': 'topical vaginal application lidocaine gel', 'type': 'DRUG', 'description': 'Application of topical vaginal lidocaine prior to cervical balloon ripening', 'armGroupLabels': ['Topical lidocaine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah Little, MD', 'role': 'CONTACT', 'email': 'slittl10@bidmc.harvard.edu', 'phone': '6176677000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sarah Little', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}