Vasculitis Pregnancy Registry (V-PREG)

University of Pennsylvania

Status: Enrolling

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

Treatments: Other: Online questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02593565

VCRC 5532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Intervention

Description:

Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.

Treatment:

Other: Online questionnaires