Vasculitis Pregnancy Registry

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Brief Title

Vasculitis Pregnancy Registry

Official Title

The Vasculitis Pregnancy Registry (V-PREG)

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 Type

Observational [Patient Registry]


Primary Outcome

Unique pregnancy characteristics among women with vasculitis.


Condition

Vasculitis

Intervention

Online questionnaires

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

November 2015

Completion Date

December 2023

Primary Completion Date

December 2022

Eligibility Criteria

        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.
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Megan Clowse, MD, MPH, , [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02593565

Organization ID

VCRC 5532


Responsible Party

Sponsor

Study Sponsor

University of Pennsylvania

Collaborators

 Duke University

Study Sponsor

Megan Clowse, MD, MPH, Study Chair, Duke University


Verification Date

April 2021