Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01235858
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2010-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aseptic Techniques During Epidural Analgesia in the Labor Floor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-03', 'studyFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter.', 'timeFrame': 'one and one half year'}], 'secondaryOutcomes': [{'measure': 'length of epidural catheterization and positive culture', 'timeFrame': 'one year and a half'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epidural analgesia', 'Epidural anesthesia labor', 'Aseptic technique', 'gown', 'no gown'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '25304478', 'type': 'DERIVED', 'citation': 'Siddiqui NT, Davies S, McGeer A, Carvalho JC, Friedman Z. The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):520-4. doi: 10.1097/AAP.0000000000000171.'}]}, 'descriptionModule': {'briefSummary': 'There is an increasing trend in the incidence of infection related to epidural anesthesia. This could be related to methods of aseptic technique as adopted by the anesthesiologist during the performance of the procedure.\n\nThe purpose of this study is to compare two methods of aseptic technique for labor epidural insertion; a "conventional" method without wearing a sterile gown (free from living germs or microorganisms) versus strict aseptic method with wearing of sterile gowns.\n\nIt is our belief that there will be an increased contamination of epidural equipment and colonization of epidural catheter, secondary to bacterial fallout from the operators\' bare hands in the group not wearing the sterile gowns.', 'detailedDescription': 'At the present time there is no accepted standard for aseptic technique during insertion of an epidural catheter on the labor floor and what is considered to be essential is controversial. Recognizing this, the American Society of Regional Anesthesia (ASRA), the leading authority on regional anesthesia, established a task force to examine and establish guidelines for aseptic practice. Their findings highlighted the lack of good quality studies to support specific recommendations. This is especially true in regards to the use of sterile gowns during the performance of the procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women requesting epidural analgesia\n\nExclusion Criteria:\n\n* Patients who have fever requiring antibiotics\n* Patients who have received antibiotics in or within the previous 48 hours of labor\n* Immuno-compromised patients.'}, 'identificationModule': {'nctId': 'NCT01235858', 'acronym': 'EAS', 'briefTitle': 'Aseptic Techniques During Epidural Analgesia in the Labor Floor', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Responding to the ASRA (American Society of Regional Anesthesia) Challenge - Should Gowning be the Standard of Practice for Epidural Anesthesia: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'EAS-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Gown group', 'description': 'Anesthesiologists wearing sterile gown for epidural insertion', 'interventionNames': ['Procedure: wearing of sterile gowns']}, {'type': 'OTHER', 'label': 'No Gown group', 'description': 'Anesthesiologists not wearing gown for epidural insertion', 'interventionNames': ['Procedure: No gown']}], 'interventions': [{'name': 'wearing of sterile gowns', 'type': 'PROCEDURE', 'otherNames': ['Sterile gowns'], 'description': 'Anesthesiologists wearing sterile gown for epidural insertion', 'armGroupLabels': ['Gown group']}, {'name': 'No gown', 'type': 'PROCEDURE', 'description': 'Anesthesiologists not wearing sterile gown for epidural insertion', 'armGroupLabels': ['No Gown group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Anesthesia Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Naveed T Siddiqui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia and Pain Management Mount Sinai Hospital, Toronto,Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Naveed Siddiqui', 'investigatorAffiliation': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}}}}