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Trial record 4 of 31 for:    Recruiting Studies | Vasculitis | United States

Vasculitis Pregnancy Registry (V-PREG)

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ClinicalTrials.gov Identifier: NCT02593565
Recruitment Status : Recruiting
First Posted : November 1, 2015
Last Update Posted : May 18, 2022
Duke University
University of South Florida
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 Other: Online questionnaires

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Vasculitis Pregnancy Registry (V-PREG)
Study Start Date : November 2015
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Group/Cohort Intervention/treatment
Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.
Other: Online questionnaires
Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with vasculitis who are currently pregnant.

Inclusion Criteria:

  1. Women 18 years of age or older with one of the following diseases may take part in the study:

    • Behcet's disease;
    • CNS vasculitis;
    • cryoglobulinemic vasculitis;
    • eosinophilic granulomatosis with polyangiitis (Churg-Strauss);
    • granulomatosis with polyangiitis (Wegener's);
    • IgA vasculitis (Henoch-Schoenlein purpura);
    • microscopic polyangiitis;
    • polyarteritis nodosa;
    • Takayasu's arteritis;
    • urticarial vasculitis.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593565

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Contact: Christine Yeung christine.yeung@pennmedicine.upenn.edu
Contact: Carol McAlear, MA cmcalear@upenn.edu

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United States, Florida
University of South Florida Data Management and Coordinating Center Recruiting
Tampa, Florida, United States, 33612
Contact: Cristina Burroughs       networkmanager@vpprn.org   
Sponsors and Collaborators
University of Pennsylvania
Duke University
University of South Florida
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Study Chair: Megan Clowse, MD, MPH Duke University
Study Chair: Peter A Merkel, MD, MPH University of Pennsylvania
Additional Information:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02593565    
Other Study ID Numbers: VCRC 5532
First Posted: November 1, 2015    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Vasculitis, Central Nervous System
Systemic Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Behcet Syndrome
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Takayasu Arteritis
Aortic Arch Syndromes
Purpura, Schoenlein-Henoch
Churg-Strauss Syndrome
Polyarteritis Nodosa
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn