Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 12:35 AM
Study NCT ID:
NCT06940869
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-28
First Post:
2025-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Network to Understand Reproductive Rheumatology Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005193', 'term': 'Family Planning Services'}], 'ancestors': [{'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D034121', 'term': 'Reproductive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2035-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edinburgh post-partum depression scale', 'timeFrame': 'up to 20 years', 'description': 'Depression at entry in NURTURE defined by the Edinburgh Postnatal Depression Scale (EPDS) score ≥10 indicating minor depression.'}], 'secondaryOutcomes': [{'measure': 'Readiness for Pregnancy', 'timeFrame': 'up to 20 years', 'description': 'We will explore the effect size of the HOP-STEP Intervention on \'personally-ready and \'medically-ready\' pregnancies by comparing women who did and did not receive the HOP-STEP Intervention.\n\n"Medically ready" will be defined as \\<1g of proteinuria, no rheumatic teratogens at conception, and continuing pregnancy compatible SLE medications after conception.\n\n"Personally ready" will be defined as a planned pregnancy based on a London Measure of Unplanned Pregnancy (LMUP) score ≥10.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatic Diseases', 'Pregnancy Related', 'Pregnancy Interest', 'Reproductive Health', 'Autoimmune Diseases']}, 'descriptionModule': {'briefSummary': "The purpose of the NURTURE Registry is to enroll those who are pregnant and/or potentially capable of pregnancy. Participants will complete patient-reported surveys at enrollment and periodically prior to conception, during pregnancy, and following the completion of the study pregnancy. The study rheumatologist will provide the patient's diagnosis and record rheumatic disease activity at each clinic visit. Medication use, vital signs, and routine laboratory assessments will be collected throughout this period. Pregnancy, maternal, and infant outcomes will be obtained through the electronic medical record and from patient-reported surveys. This Registry will provide a rich data repository for research to improve pregnancy and birth outcomes for women with rheumatic diseases and will be used in on-going and future research to better understand the risk factors that are associated with poor pregnancy outcomes, including preterm birth, intrauterine growth restriction, and preeclampsia, as well as the effects of medication on disease management in pregnancy. Infant outcomes, medications, provider care, pregnancy planning, and social determinants of health on pregnancy and pregnancy outcomes will also be collected.\n\nThe majority of the information collected in NURTURE, such as labs, disease activity, and medications, PRO's will originate from the EHR. Upon consent, participants will complete an enrollment survey that will include relevant patient reported measures. No study visits outside of routine care will occur. Participants may also complete a yearly survey about their reproductive health journey.\n\nThe registry will be ongoing and will include periodic analysis of clinical data within this protocol. Additional analysis will be covered under seperate IRB approved protocols. Enrollment in the registry does not significantly increase the risk for a patient.", 'detailedDescription': "The purpose of the NURTURE Registry is to obtain information on those who are pregnant and/or potentially capable of pregnancy. This Registry will provide a rich data repository for research to improve pregnancy and birth outcomes for women with rheumatic diseases and will be used in on-going and future research to better understand the risk factors that are associated with poor pregnancy outcomes, including preterm birth, intrauterine growth restriction, and preeclampsia, as well as the effects of medication on disease management in pregnancy. Infant outcomes, medications, provider care, pregnancy planning, and social determinants of health on pregnancy and pregnancy outcomes will also be collected.\n\nParticipation in NURTURE will be seamless with routine patient care. Any patient with a rheumatic disease seen by a participating site study provider as part routine care, and who could potentially become pregnant (females between the ages of 12 and 55), or who is currently pregnant, will be invited to participate in NURTURE. Participants will complete patient-reported surveys at enrollment and periodically prior to conception, during pregnancy, and following the completion of the study pregnancy. The study rheumatologist will provide the patient's diagnosis and record rheumatic disease activity at each clinic visit. Medication use, vital signs, and laboratory assessments will be collected as part of standard clinical care vistis and used in this registry. Pregnancy, maternal, and infant outcomes will be obtained through the electronic medical record and from patient-reported surveys.\n\nPrior to or at each standard of care (non-study, routine) visit, the patient will complete routine clinical questionnaires.\n\nThis is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care. Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician.\n\nEnrollment in the registry will not dictate specific therapy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Currently pregnant or desire to become pregnant and have an autoimmune or rheumatic condition.', 'genderDescription': 'Capable of pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of an automimmune or rheumatic condition determined by health care provider.\n2. Age 12-55 who are capable of pregnancy (currently pregnant or planning a pregnancy).\n3. A patient who receives their care in the Duke Health System.\n4. Capable of providing informed consent.\n\nExclusion Criteria:\n\n1\\. Unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06940869', 'acronym': 'NURTURE', 'briefTitle': 'Network to Understand Reproductive Rheumatology Registry', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Network to Understand Reproductive Rheumatology Registry', 'orgStudyIdInfo': {'id': 'Pro00117179'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NURTURE Registry', 'type': 'OTHER', 'otherNames': ['Women with rheumatic/autoimmune diseases who are pregnant or planning pregnancy'], 'description': 'To improve pregnancy and birth outcomes for women with rheumatic diseases and to understand risk factors associated with poor pregnancy outcomes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Megan Clowse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine, Duke University Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}