Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-16 @ 9:30 AM
Study NCT ID:
NCT03368157
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2017-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREG-MS: New England MS Pregnancy Registry
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The weight (pounds) of infants born to MS affected mothers', 'timeFrame': '3 years', 'description': 'The evaluation of the weight in pounds of infants born to mothers affected by MS compared to standard pediatric measurements.'}, {'measure': 'The length (inches) of infants born to MS affected mothers', 'timeFrame': '3 years', 'description': 'The evaluation of the length in inches of infants born to mothers affected by MS compared to pediatric standard measurements.'}, {'measure': 'The head circumference (inches) of infants born to MS affected mothers', 'timeFrame': '3 years', 'description': 'The evaluation of the head circumference in inches of infants born to mothers affected by MS compared to pediatric standard measurements.'}], 'primaryOutcomes': [{'measure': 'The relationship between EDSS and pregnancy course', 'timeFrame': '9 months', 'description': 'The investigators assessed the correlation between EDSS scores and the presence of pregnancy complications, or the lack thereof.'}], 'secondaryOutcomes': [{'measure': 'The relationship between MS treatments and pregnancy course', 'timeFrame': '9 months', 'description': 'The investigators assessed the effects of Disease modifying therapies used to treat MS and its implication on the pregnancy course.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '39810912', 'type': 'DERIVED', 'citation': 'Houtchens MK, Manieri MC, Mahlanza TD, Pol-Patil J, Klawiter EC, Solomon AJ, Lathi E, Katz J, Ionete C, Morales IB, Severson C, Zurawski J, Stankiewicz JM, Cabot A, Sadovnick AD. A Real-World Prospective Multiple Sclerosis Pregnancy Registry in the United States: PREG-MS. Neurol Clin Pract. 2025 Apr;15(2):e200425. doi: 10.1212/CPJ.0000000000200425. Epub 2025 Jan 10.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate.\n\nThe study will solely take place through phone interviews. One of the study coordinator at the Partners MS Center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their MS will be collected. Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. After birth, the coordinator will collect information on the growth and development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study.\n\nThrough this study, the investigators hope to learn more about the effects of MS on pregnancy and pediatric development, and about the effects of pregnancy on the course of MS."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who are pregnant or are actively trying to become pregnant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Multiple Sclerosis;\n* Pregnant or actively planning to become pregnant.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03368157', 'briefTitle': 'PREG-MS: New England MS Pregnancy Registry', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'PREG-MS: New England MS Pregnancy Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2016P000588'}}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology', 'investigatorFullName': 'Maria Houtchens', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}