Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-03 @ 5:15 AM
Study NCT ID:
NCT05010902
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Cohort in Multiple Sclerosis (MS)
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time until relapse', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Time (in days) until relapse during the observation period'}], 'secondaryOutcomes': [{'measure': 'Number of T2 lesions', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Number of T2 lesions in spinal and cerebral magnetic resonance imaging'}, {'measure': 'Number of gadolinium enhancing lesions', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Number of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging'}, {'measure': 'Volume of T2 lesions', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Volume of T2 lesions in spinal and cerebral magnetic resonance imaging'}, {'measure': 'Volume of gadolinium enhancing lesions', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Volume of gadolinium enhancing lesions in spinal and cerebral magnetic resonance imaging'}, {'measure': 'Change in immune cell phenotypes', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Change in immune cell phenotypes of peripheral blood mononuclear cells (PBMC)'}, {'measure': 'Galectin-1', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Change in serum galectin-1 concentration measured by ELISA'}, {'measure': 'Galectin-3', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Change in serum galectin-3 concentration measured by ELISA'}, {'measure': 'Galectin-9', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Change in serum galectin-9 concentration measured by ELISA'}, {'measure': 'Neurofilament (NfL)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Change in neurofilament serum concentration by using Simoa NfL assay'}, {'measure': 'Pro-inflammatory interleukin-17', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Change in interleukin-17 serum concentration assessed by ELISA'}, {'measure': 'Anti-inflammatory interleukin-10', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Change in anti-inflammatory interleukin-10 serum concentration assessed by ELISA'}, {'measure': 'Autoantibody profiling', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Identification and quantification of autoantibodies by using protein microarray and ELISA'}, {'measure': 'Fecal microbiome composition', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Composition of fecal microbiome measured by 16S Sequencing'}, {'measure': 'Thickness of the retinal nerve fibre layer', 'timeFrame': '12 months after delivery (compared to baseline)', 'description': 'Thickness of the retinal nerve fibre layer by Optical Coherence Tomography (OCT)'}, {'measure': 'Total macular volume (TMV)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Total macular volume by Optical Coherence Tomography (OCT)'}, {'measure': 'Mini-International Neuropsychiatric Interview (M.I.N.I.) German Version 5.0.0 Module A-C', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Structured diagnostic interview to assess depression, dysthymia and suicidality'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Rating of ten depression related symptoms on a scale from 0 to 6 (higher numbers indicate more severe symptoms)'}, {'measure': 'Beck Depression Inventory (BDI-II)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Rating of 21 depression related symptoms on a scale from 0 to 3 (higher numbers indicate more severe symptoms)'}, {'measure': 'Edinburgh Postpartum Depression Scale (EPDS)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'Self-report survey containing 10 items, each item is rated 0-3 (higher scores indicate a higher probability of postpartum depression)'}, {'measure': 'Modified Fatigue Inventory Scale (MFIS)', 'timeFrame': '12 months after delivery compared to baseline', 'description': "Self-report survey containing 21 items, each item is rated 0-4 (higher scores indicate a greater impact of fatigue on a person's activities)"}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'A self-report survey consisting of 11 items, each item ranges from 1 to 7 (higher scores indicate higher levels of fatigue)'}, {'measure': 'Visual Fatigue Analogue Scale (VFAS)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'A self-administered, single scale indication measuring visual fatigue, ranging from 0 to 100 (higher scores indicate worse fatigue)'}, {'measure': 'Short-Form Health Survey (SF-36)', 'timeFrame': '12 months after delivery compared to baseline', 'description': 'A self-report survey measuring health in eight dimensions (higher scores indicate less disability)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy'], 'conditions': ['Multiple Sclerosis (MS)', 'Clinically Isolated Syndrome (CIS)']}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (MS) is a common inflammatory demyelinating disorder of the central nervous system frequently affecting females in their reproductive phase of life. In this prospective observational study, we obtain data on the outcome of pregnancies in MS patients and the influence of pregnancy on clinical, laboratory and MRI parameters in MS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients will be recruted at neurological outpatient clinics and neurological clinics of the Charité and neurologists' medical practices.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* signed informed consent\n* diagnosis of multiple sclerosis or clinically isolated syndrome\n\nExclusion Criteria:\n\n* clinically relevant comorbidities\n* contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium\n* alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT05010902', 'briefTitle': 'Pregnancy Cohort in Multiple Sclerosis (MS)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Pregnancy Cohort in Multiple Sclerosis (MS)', 'orgStudyIdInfo': {'id': 'PreCoMS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple sclerosis', 'description': 'Patients with clinically isolated syndrome, relapsing-remitting or progressive multiple sclerosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13125', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nadja Siebert, MD', 'role': 'CONTACT', 'email': 'nadja.siebert@charite.de'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Nadja Siebert, MD', 'role': 'CONTACT', 'email': 'nadja.siebert@charite.de'}, {'name': 'Friedemann Paul, Prof.', 'role': 'CONTACT', 'email': 'friedemann.paul@charite.de'}], 'overallOfficials': [{'name': 'Nadja Siebert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Experimental & Clinical Research Unit, Charité Universitätsmedizin Berlin'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification', 'accessCriteria': 'Researchers who provide a methodologically sound proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nadja Siebert', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}