Clinical trial NCT02593565: Vasculitis Pregnancy Registry
Official title: The Vasculitis Pregnancy Registry (V-PREG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Duke University
name: University of South Florida
First posted: 2015-11-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with vasculitis who are currently pregnant.

Brief summary: 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.

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.

Primary outcomes:
measure: Unique pregnancy characteristics among women with vasculitis.
timeFrame: Four years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Data Management and Coordinating Center
state: Florida
Study officials:
affiliation: Duke University
name: Megan Clowse, MD, MPH
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Peter A Merkel, MD, MPH
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.