Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-11 @ 3:41 AM
Study NCT ID:
NCT03247894
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstetric Anesthesia and Analgesia and Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'targetDuration': '10 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-25', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multiple sclerosis decompensation/progression at 3rd month', 'timeFrame': '3 months after labour', 'description': 'Relapse occurence from labour to 3 months, after delivery was recorded. A relapse was defined as the appearance or worsening of symptoms of neurologic dysfunction lasting more than 24 hours, new lesions on MRI or need of reinforcement in treatment. For disease state after delivery we used dichotomic approach: relapse (at least one) or no relapses.'}, {'measure': 'Multiple sclerosis decompensation/progression', 'timeFrame': '3 months after labour', 'description': 'Relapse occurence from labour to 6 months after delivery'}], 'secondaryOutcomes': [{'measure': 'MS progression and the type of anesthetic method', 'timeFrame': '6 months after labour', 'description': 'MS progression comparison due to the type of anethesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis, anesthesia'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Aim of the retrospective study was to evaluate the influence of the labour on the clinical course of the parturients with MS in selected 6 month follow-up interval and to evaluate to possible influence of the different anesthesia/analgesia types on the course of MS.', 'detailedDescription': 'The role of anesthesia in multiple sclerosis (MS) progression remains unclear in spite of few foreign studies. The most frequently afflicted patients by MS are women of childbearing age and influence of anesthesia or obstetric epidural analgesia has only not been investigated in Czech Republic. The study aims to retrospectively compare the further course of the disease of MS in patients who labor between 2004 and 2013 in University Hospital Brno either by caesarean section or vaginally with epidural analgesia , with patients who gave birth spontaneously without anesthesia.The aim of the study was to evaluate the influence of the labour on the clinical course of MS and further evaluate the possible influence of the type of anesthesia/analgesia in the peripartal period on the MS progression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parturients with multiple sclerosis after labour in tertiary perinatology center', 'genderDescription': 'Parturients with multiple sclerosis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturients with multiple sclerosis\n* Possible follow up - neurologic examination available after 10 month from delivery\n\nExclusion Criteria:\n\n* probable or no multiple sclerosis at time of labor\n* unknown neurology history\n* unknown data on neurology outcome 6 months after labour\n* Incomplete data\n* Follow-up not possible'}, 'identificationModule': {'nctId': 'NCT03247894', 'acronym': 'OBAANAMS', 'briefTitle': 'Obstetric Anesthesia and Analgesia and Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Influence of Obstetric Anesthesia and Analgesia on the Progression of the Disease in Multiple Sclerosis Parturients: Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'KDAR FN Brno 2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS patients who after labour', 'description': 'Patients with multiple sclerosis after labour in tertiary center was screened for progression of MS in 10 months period after labour', 'interventionNames': ['Other: Data search']}], 'interventions': [{'name': 'Data search', 'type': 'OTHER', 'description': 'Patients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period', 'armGroupLabels': ['MS patients who after labour']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno, Czechia, 62500', 'state': 'Czechia', 'country': 'Czechia', 'facility': 'Brno University Hospital', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doc.MD. Ph.D.', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}