The Vasculitis Pregnancy Registry (V-PREG)
| Registry | NCT02593565, acronym V-PREG |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | University of Pennsylvania (Other); collaborators: Duke University, University of South Florida |
| Conditions | 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 |
| Interventions | Online questionnaires (Other) |
| Dates | start 2015-11-01, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2015-11-02, last updated 2026-01-23 |
| Locations | 1 site in United States |
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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
1. each woman's vasculitis severity and pregnancy-related experiences, and
2. pregnancy outcomes.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention | Other: Online questionnaires | Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis. |
Sex: Female, ages: 18 Years to 50 Years
Inclusion Criteria: 1. Women 18 years of age or older with one of the following diseases may take part in the study: * 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: 1. Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish. 2. Unable to provide consent.
| Facility | City | Country | Status |
|---|---|---|---|
| University of South Florida Data Management and Coordinating Center | Tampa, Florida | United States | Recruiting |