Vasculitis Pregnancy Registry

Study Overview
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Brief Summary
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The purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess each woman's vasculitis severity and pregnancy-related experiences, and pregnancy outcomes.

Detailed Description
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The study will consist of several on-line surveys to assess each woman's vasculitis severity, pregnancy-related experiences, and pregnancy outcomes. Participants will be asked to complete questionnaires at study entry, during the second trimester, during the third trimester, and postpartum. Investigators estimate that it will take approximately 20 minutes to complete each survey. The survey is available in Spanish, Portuguese, Italian, and Turkish. 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.

Official Title
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The Vasculitis Pregnancy Registry (V-PREG)

Conditions
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Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Churg-Strauss Syndrome (CSS), Granulomatosis With Polyangiitis (GPA), Wegener's Granulomatosis, IgA Vasculitis, Henoch-Schoenlein Purpura (HSP), Microscopic Polyangiitis (MPA), Polyarteritis Nodosa (PAN), Takayasu Arteritis (TAK), Urticarial Vasculitis, Systemic Vasculitis

Intervention / Treatment
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* Other: Online questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years of age or older with one of the following diseases may take part in the study: Behcet's disease; CNS vasculitis; cryoglobulinemic vasculitis; eosinophilic granulomatosis with polyangiitis (Churg-Strauss); granulomatosis with polyangiitis (Wegener's); IgA vasculitis (Henoch-Schoenlein purpura); microscopic polyangiitis; polyarteritis nodosa; Takayasu's arteritis; urticarial vasculitis. Women must be pregnant (self-report) at the time of enrollment into the registry. Exclusion Criteria: Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish. Unable to provide consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis. | Other: Online questionnaires<br>* Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unique pregnancy characteristics among women with vasculitis. | To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester. | Four years |