Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-01 @ 9:16 PM
Study NCT ID:
NCT00670020
Status:
COMPLETED
Last Update Posted:
2008-05-01
First Post:
2008-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-30', 'studyFirstSubmitDate': '2008-04-29', 'studyFirstSubmitQcDate': '2008-04-30', 'lastUpdatePostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical site infection', 'timeFrame': 'within two weeks of cesarean section'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Women undergoing Cesarean section after the onset of labor'], 'conditions': ['Wound Infection or Endometritis Post Cesarean Section']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether supplemental perioperative oxygen significantly decreases the incidence of post-Cesarean endometritis and wound infection among women who undergo Cesarean section after the onset of labor.', 'detailedDescription': 'Women undergoing cesarean section after rupture of membranes or onset of labor are randomized in a one to one ratio to either normal or supplemental perioperative oxygen during cesarean section and for two hours afterwards.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who underwent a clinically indicated cesarean delivery after the onset of labor or rupture of membranes\n\nExclusion Criteria:\n\n* Cesarean delivery prior to the onset of labor or rupture of membranes\n* emergent cesarean delivery\n* general endotracheal anesthesia\n* clinical chorioamnionitis\n* HIV infection\n* less than 16 years of age'}, 'identificationModule': {'nctId': 'NCT00670020', 'briefTitle': 'Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection', 'orgStudyIdInfo': {'id': '18821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'supplemental perioperative oxygen', 'interventionNames': ['Procedure: supplemental perioperative oxygen']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Normal'}], 'interventions': [{'name': 'supplemental perioperative oxygen', 'type': 'PROCEDURE', 'description': 'increased perioperative oxygen verses non-interventional oxygen', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carolyn M Gardella, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington Dept of Ob/Gyn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Carolyn Gardella, MD, MPH', 'oldOrganization': 'University of Washington'}}}}