Vasculitis Pregnancy Registry

Recruiting

• Conditions: Cryoglobulinemic Vasculitis; Eosinophilic Granulomatosis With Polyangiitis (EGPA); Henoch-Schoenlein Purpura (HSP); Microscopic Polyangiitis (MPA); Systemic Vasculitis; Behcet's Disease; Granulomatosis With Polyangiitis (GPA); IgA Vasculitis; Churg-Strauss Syndrome (CSS); Vasculitis
• Interventions: Other: Online questionnaires

• Registration Number: NCT02593565
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-29
• Study Start: 2015-11
• Study First Posted: 2015-11-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Read More

Exclusion Criteria

1. Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.
2. Unable to provide consent.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Online questionnaires	Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.

Primary Outcome Measures

Name	Time	Method
Unique pregnancy characteristics among women with vasculitis.	Four years	To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.

Trial Locations

Locations (1)

University of South Florida Data Management and Coordinating Center; 🇺🇸 Tampa, Florida, United States