Vasculitis Pregnancy Registry

Vasculitis Clinical Trial

— V-PREG  

Official title:

The Vasculitis Pregnancy Registry (V-PREG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02593565
• Other study ID #: VCRC 5532
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: University of Pennsylvania
• Contact: Christine Yeung
• Email: christine.yeung[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of South Florida Data Management and Coordinating Center	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Duke University, University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

Clowse ME, Richeson RL, Pieper C, Merkel PA; Vasculitis Clinical Research Consortium. Pregnancy outcomes among patients with vasculitis. Arthritis Care Res (Hoboken). 2013 Aug;65(8):1370-4. doi: 10.1002/acr.21983. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unique pregnancy characteristics among women with vasculitis.	To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.	Four years

External Links

•   The Vasculitis Patient-Powered Research Network
•   Vasculitis Pregnancy Registry (VPREG) Information