Vasculitis Pregnancy Registry (V-PREG)

May 25, 2023 updated by: University of Pennsylvania

The Vasculitis Pregnancy Registry (V-PREG)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida Data Management and Coordinating Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with vasculitis who are currently pregnant.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

University of South Florida
Duke University

Investigators

  • Study Chair: Peter A Merkel, MD, MPH, University of Pennsylvania
  • Study Chair: Megan Clowse, MD, MPH, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimated)

November 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCRC 5532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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