Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-04 @ 10:17 PM
Study NCT ID:
NCT02865551
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Retention After Vaginal Delivery With Epidural Anesthesia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000767', 'term': 'Anesthesia, Epidural'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-21', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of urinary retention after vaginal delivery with epidural anesthesia', 'timeFrame': 'Up to 3 days'}], 'secondaryOutcomes': [{'measure': 'Rate of urinary tract infections', 'timeFrame': 'Up to 3 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Retention']}, 'descriptionModule': {'briefSummary': 'The investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor.', 'detailedDescription': "An explanation about the study will be delivered to each participant and each participant will sign a confirmed consent. Patients will be randomized between 2 groups of treatment: 1. intermittent catheterization applied every 4 hours during labor. 2. foley catheter inserted adjacent to epidural anesthesia.\n\nIn patients with a foley catheter, the catheter will be removed soon after delivery. Participants will be followed by a clinician post labor. An abdominal US will be performed either 4 hours after delivery or after the participant urinates to check the bladder volume.\n\nPatient information including demographic information, information regarding the patient's pregnancy and delivery will be collected from the patient's electronic record."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients in labor designated for vaginal delivery with epidural anesthesia.\n\nExclusion Criteria:\n\n* Patients with neurological problems including gestational diabetes.\n* Patients either designated for elective cesarean delivery or emergent cesarean delivery.'}, 'identificationModule': {'nctId': 'NCT02865551', 'briefTitle': 'Urinary Retention After Vaginal Delivery With Epidural Anesthesia.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Rate of Urinary Retention in Women After Vaginal Delivery With Epidural Anesthesia Who Underwent Prolonged Catheterization Compared With Intermittent Catheterization During Labor.', 'orgStudyIdInfo': {'id': '0141-15-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended catheterization', 'description': 'Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.', 'interventionNames': ['Device: Foley catheter', 'Drug: Epidural anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent catheterization', 'description': 'Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.', 'interventionNames': ['Device: Short term catheter', 'Drug: Epidural anesthesia']}], 'interventions': [{'name': 'Foley catheter', 'type': 'DEVICE', 'description': 'Extended bladder catheterization after epidural anesthesia.', 'armGroupLabels': ['Extended catheterization']}, {'name': 'Short term catheter', 'type': 'DEVICE', 'description': 'Intermittent catheterization every 4 hours after epidural anesthesia.', 'armGroupLabels': ['Intermittent catheterization']}, {'name': 'Epidural anesthesia', 'type': 'DRUG', 'description': 'Performance of epidural anesthesia by a certified anesthesiologist.', 'armGroupLabels': ['Extended catheterization', 'Intermittent catheterization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Roy Lauterbach, MD', 'role': 'CONTACT', 'email': 'r_lauterbach@rambam.health.gov.il', 'phone': '0529432416'}, {'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Roy Lauterbach, MD', 'role': 'CONTACT', 'email': 'r_lauterbach@rambam.health.gov.il', 'phone': '972529432416'}], 'overallOfficials': [{'name': 'Lior Lowenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Roy Lauterbach', 'investigatorFullName': 'ROY LAUTERBACH MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}