Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 10:35 AM
Study NCT ID:
NCT00811304
Status:
WITHDRAWN
Last Update Posted:
2013-02-04
First Post:
2008-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Ultrasound Guided Labor Epidural Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'We are unable to find a clip used to stabilize the epidural needle on the ultrasound probe to allow adequate epidural catheter placement.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-01', 'studyFirstSubmitDate': '2008-12-16', 'studyFirstSubmitQcDate': '2008-12-17', 'lastUpdatePostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failed epidural placement rate', 'timeFrame': 'From admission untill delivery'}], 'secondaryOutcomes': [{'measure': 'The incidence of post dural puncture headache.', 'timeFrame': 'From insertion of epidural to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ultrasound', 'labor epidural', 'failed epidural', 'outcome', 'Epidural insertion under realtime ultrasound guidance'], 'conditions': ['Epidural Anesthesia']}, 'descriptionModule': {'briefSummary': 'Specific Aim: The purpose of this study is to determine if labor epidural placement using real-time (concurrent) ultrasound guided placement is superior to the conventional "standard" epidural technique without the use of ultrasound at Magee-Womens Hospital.\n\nHypothesis: Ultrasound guided labor epidural placement in real-time will decrease the traditional epidural failure rate from 5% to 1%.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant women in labor.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital will be eligible to participate in the study.\n\nExclusion Criteria:\n\n* Men will not be included.'}, 'identificationModule': {'nctId': 'NCT00811304', 'briefTitle': 'Real-time Ultrasound Guided Labor Epidural Placement', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Real-time Ultrasound Guided Labor Epidural Placement', 'orgStudyIdInfo': {'id': 'PRO08090016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'US group', 'description': 'All patients admitted to the labor and delivery suite who request an epidural for labor analgesia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Manuel C Vallejo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Manuel C. Vallejo, MD / Associate Professor/University Faculty Member', 'oldOrganization': 'Magee-Womens Hospital of UPMC'}}}}