Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2015-11-30
2027-12-31
Brief Summary
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1. each woman's vasculitis severity and pregnancy-related experiences, and
2. pregnancy outcomes.
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Detailed Description
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All women enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) (with specified disease, sex, and age inclusion criteria described below) will be invited via email to participate in this on-line study. The survey data will be stored by the Data Management and Coordinating Center (DMCC) at the University of South Florida. Upon conclusion of the study period, the data will be sent to the Study Chairs.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention
Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.
Online questionnaires
Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.
Interventions
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Online questionnaires
Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.
Eligibility Criteria
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Inclusion Criteria
* Behçet's disease;
* Central nervous system (CNS) vasculitis;
* Cryoglobulinemic vasculitis (Cryoglobulinemia);
* Eosinophilic granulomatosis with polyangiitis (also called Churg-Strauss Syndrome);
* Giant Cell (Temporal) Arteritis (GCA);
* Granulomatosis with polyangiitis (also called Wegener's);
* IgA vasculitis (Henoch-Schoenlein purpura);
* Microscopic polyangiitis (MPA);
* Polyarteritis nodosa (PAN);
* Takayasu's arteritis (TAK);
* Urticarial vasculitis;
* Other/Suspected Diagnosis.
2. Women must be pregnant (self-report) at the time of enrollment into the registry.
Exclusion Criteria
2. Unable to provide consent.
18 Years
50 Years
FEMALE
No
Sponsors
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Duke University
OTHER
University of South Florida
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Megan Clowse, MD, MPH
Role: STUDY_CHAIR
Duke University
Peter A Merkel, MD, MPH
Role: STUDY_CHAIR
University of Pennsylvania
Locations
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University of South Florida Data Management and Coordinating Center
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Sims CA, Eudy AM, Larson K, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB; VPREG Collaborative Group. Reproductive Outcomes for Women With Vasculitis. J Rheumatol. 2024 Oct 1;51(10):1003-1008. doi: 10.3899/jrheum.2023-1246.
Sims CA, Perry B, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB. Exploring Reproductive Experiences With Women Enrolled in the International Vasculitis Pregnancy Registry. J Rheumatol. 2024 Oct 1;51(10):997-1002. doi: 10.3899/jrheum.2023-1055.
Related Links
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The Vasculitis Patient-Powered Research Network
Vasculitis Pregnancy Registry (VPREG) Information
Other Identifiers
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VCRC 5532
Identifier Type: -
Identifier Source: org_study_id
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