Vasculitis Pregnancy Registry

NCT02593565 | Recruiting

• 1 other identifier: VCRC 5532
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.each woman's vasculitis severity and pregnancy-related experiences, and
2. 2.pregnancy outcomes.

Conditions

Behcet's Disease; CNS Vasculitis; 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; Vasculitis; Eosinophilic Granulomatosis With Polyangiitis (EGPA); Cryoglobulinemic Vasculitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention

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

Other: Online questionnaires

Interventions

Online questionnaires OTHER

Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with vasculitis who are currently pregnant.

You may qualify if:

• 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.
• Women must be pregnant (self-report) at the time of enrollment into the registry.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Duke University: collaborator
• University of South Florida: collaborator

Study Sites (1)

University of South Florida Data Management and Coordinating Center

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 38825354 RESULT

• 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.

  PMID: 38825350 RESULT

Related Links

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

MeSH Terms

Conditions

Vasculitis; Behcet Syndrome; Vasculitis, Central Nervous System; Cryoglobulinemia, Familial Mixed; Churg-Strauss Syndrome; Granulomatosis with Polyangiitis; IgA Vasculitis; Microscopic Polyangiitis; Polyarteritis Nodosa; Takayasu Arteritis; Systemic Vasculitis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Immune Complex Diseases; Hypersensitivity; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Cerebral Small Vessel Diseases; Arteritis; Aortic Arch Syndromes; Aortic Diseases

Study Officials

• Megan Clowse, MD, MPH

  Duke University

  STUDY CHAIR

• Peter A Merkel, MD, MPH

  University of Pennsylvania

  STUDY CHAIR

Central Study Contacts

Christine Yeung

CONTACT

christine.yeung@pennmedicine.upenn.edu

Carol McAlear, MA

CONTACT

cmcalear@upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 2, 2015
• Study Start: November 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)