Registry for women with vasculitis during pregnancy

The Vasculitis Pregnancy Registry (V-PREG)

This study is gathering information from pregnant women with vasculitis to understand their experiences and health outcomes during and after pregnancy.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: University of Pennsylvania (Academic / other)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT02593565 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather information about the experiences of women with various types of vasculitis who are pregnant. Participants will complete online surveys assessing their vasculitis severity, pregnancy-related experiences, and outcomes at multiple points during their pregnancy and postpartum. The surveys are designed to be accessible in several languages, including Spanish, Portuguese, Italian, and Turkish. Data collected will be managed by the University of South Florida's Data Management and Coordinating Center.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older who are pregnant and have a diagnosis of one of the specified types of vasculitis.

Not a fit: Patients who do not speak one of the supported languages or are unable to provide consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the management of pregnancy in women with vasculitis, potentially improving maternal and fetal outcomes.

How similar studies have performed: While there may be limited studies specifically focused on pregnancy outcomes in women with vasculitis, the approach of using patient-reported outcomes through surveys has been successful in other similar patient registries.

Eligibility criteria

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.

Where this trial is running

Tampa, Florida

• University of South Florida Data Management and Coordinating Center — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Christine Yeung

Conditions Vasculitis; Behcet's Disease; CNS Vasculitis; Cryoglobulinemic Vasculitis; Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome; Granulomatosis With Polyangiitis; Wegener's Granulomatosis