Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-28 @ 7:56 AM
Study NCT ID:
NCT05973435
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2023-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elevated level of oxidative stress', 'timeFrame': '2 hours after C section', 'description': 'We will measure enzymes of oxidative stress before cesarean section, during cesarean section and after cesarean section.'}], 'secondaryOutcomes': [{'measure': 'Lactate level', 'timeFrame': '2 hours after C section', 'description': 'We will measure lactate levels before cesarean section, during cesarean section and after cesarean section.'}, {'measure': 'Level of cortisol', 'timeFrame': '2 hours after C section', 'description': 'We will measure cortisol levels before cesarean section, during cesarean section and after cesarean section.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstetric Anesthesia Problems']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess the level of oxidative stress during cesarean section depending on the type of anesthesia applied and to determine the factors that can affect the level of oxidative stress.\n\nThe main questions it aims to answer are:\n\n* is there any association between specific parameters of pregnancy, socio-demographic characteristics and laboratory analyses with an increased level of oxidative stress\n* is there any association between type of anesthesia for ceasarean section with an increased level of oxidative stress\n\nBlood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).\n\nResearchers will compare patients that received general anesthesia with patients under spinal regional anesthesia to see if there is any difference in level of oxidative stress measured by laboratory parameters.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status I and II\n\nExclusion Criteria:\n\n* ASA status III and IV\n* Emergency C section'}, 'identificationModule': {'nctId': 'NCT05973435', 'briefTitle': 'Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University Clinic Dr Dragisa Misovic-Dedinje'}, 'officialTitle': 'Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section', 'orgStudyIdInfo': {'id': '17/I-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Anesthesia', 'interventionNames': ['Other: Blood sampling']}, {'label': 'Spinal anesthesia', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).', 'armGroupLabels': ['General Anesthesia', 'Spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinic Dr Dragisa Misovic-Dedinje', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marina Boboš', 'investigatorAffiliation': 'University Clinic Dr Dragisa Misovic-Dedinje'}}}}