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NCT Number: NCT02593565

Vasculitis Pregnancy Registry

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.

Recruiting

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Key information

Conditions

Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Aortic Arch Syndromes Aortic Diseases Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behcet Syndrome Behcet's Disease Blood Coagulation Disorders Brain Diseases CNS Vasculitis Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Churg-Strauss Syndrome Churg-Strauss Syndrome (CSS) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryoglobulinemia, Familial Mixed Cryoglobulinemic Vasculitis Eosinophilic Granulomatosis With Polyangiitis (EGPA) Eye Diseases Genetic Diseases, Inborn Granuloma Granulomatosis With Polyangiitis (GPA) Granulomatosis with Polyangiitis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Henoch-Schoenlein Purpura (HSP) Hereditary Autoinflammatory Diseases Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Microscopic Polyangiitis Microscopic Polyangiitis (MPA) Mouth Diseases Nervous System Diseases Panuveitis Pathologic Processes Pathological Conditions, Signs and Symptoms Polyarteritis Nodosa Polyarteritis Nodosa (PAN) Purpura Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Stomatognathic Diseases Systemic Vasculitis Takayasu Arteritis Takayasu Arteritis (TAK) Urticarial Vasculitis Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis, Central Nervous System Wegener's Granulomatosis

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of South Florida Data Management and Coordinating Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Cristina Burroughs

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

online questionnaires

Other

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

Primary outcomes

  1. Unique pregnancy characteristics among women with vasculitis.

    Time frame: Four years

    To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.

Study contacts

Contact information is provided by the study sponsor or research team.

Carol McAlear, MA

CONTACT

[email protected]

Christine Yeung

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Duke University
  • University of South Florida

Registry information

Official study title

The Vasculitis Pregnancy Registry (V-PREG)

Acronym: V-PREG

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Nov 2, 2015
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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