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Recruiting NCT02593565

Vasculitis Pregnancy Registry

— Observational Vasculitis Behcet's Disease CNS Vasculitis Cryoglobulinemic Vasculitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Online questionnaires.
Who it may be relevant to
Registry conditions: Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Vasculitis Pregnancy Registry (V-PREG)

Overview

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.

Detailed description

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.

Interventions

  • Other Online questionnaires
    Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.

Primary outcome measures

  • Unique pregnancy characteristics among women with vasculitis. [Time frame: Four years]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of South Florida Data Management and Coordinating Center — Tampa

Publications

  • 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. PMID 38825354
  • 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. PMID 38825350

Identifiers

NCT: NCT02593565 · VCRC 5532

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗