Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vasculitis Pregnancy Registry (V-PREG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02593565
Recruitment Status : Recruiting
First Posted : November 1, 2015
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
Duke University
University of South Florida
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date October 26, 2015
First Posted Date November 1, 2015
Last Update Posted Date March 24, 2020
Study Start Date November 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with vasculitis who are currently pregnant.
Condition
  • 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
Intervention Other: Online questionnaires
Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.
Study Groups/Cohorts Intervention
Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.
Intervention: Other: Online questionnaires
Publications * Clowse ME, Richeson RL, Pieper C, Merkel PA; Vasculitis Clinical Research Consortium. Pregnancy outcomes among patients with vasculitis. Arthritis Care Res (Hoboken). 2013 Aug;65(8):1370-4. doi: 10.1002/acr.21983.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 29, 2015)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
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.
  2. Unable to provide consent.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cristina Burroughs networkmanager@vpprn.org
Contact: Carol McAlear, MA cmcalear@upenn.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02593565
Other Study ID Numbers VCRC 5532
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators
  • 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
PRS Account University of Pennsylvania
Verification Date March 2020