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Vasculitis Pregnancy Registry (V-PREG)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of Pennsylvania
Sponsor:
Collaborators:
Duke University
University of South Florida
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02593565
First received: October 26, 2015
Last updated: April 27, 2017
Last verified: April 2017
  Purpose

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 Intervention
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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Vasculitis Pregnancy Registry (V-PREG)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: November 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention
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.

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.

All women enrolled in the Vasculitis Patient-Powered Research Network (V-PPRN) (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.

  Eligibility

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.
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.
  2. Unable to provide consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02593565

Contacts
Contact: Cristina Burroughs networkmanager@vpprn.org
Contact: Carol McAlear, MA cmcalear@upenn.edu

Locations
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
Investigators
Study Chair: Megan Clowse, MD, MPH Duke University
Study Chair: Peter A Merkel, MD, MPH University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02593565     History of Changes
Other Study ID Numbers: VCRC 5532
Study First Received: October 26, 2015
Last Updated: April 27, 2017

Additional relevant MeSH terms:
Purpura
Vasculitis
Granulomatosis with Polyangiitis
Behcet Syndrome
Churg-Strauss Syndrome
Microscopic Polyangiitis
Takayasu Arteritis
Aortic Arch Syndromes
Arteritis
Systemic Vasculitis
Purpura, Schoenlein-Henoch
Polyarteritis Nodosa
Vasculitis, Central Nervous System
Cryoglobulinemia
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 22, 2017