ClinicalTrials.gov record NCT02593565
Vasculitis Pregnancy Registry
The Vasculitis Pregnancy Registry (V-PREG)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational registry studies the experiences and outcomes of pregnant women with vasculitis. Participants complete online questionnaires at study entry, in the second and third trimesters, and after delivery. Surveys take about 20 minutes each and are available in English, Spanish, Portuguese, Italian, and Turkish. Taking part is by invitation: the registry says women already enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) who meet the criteria are invited by email.
What it is studying. The study is collecting patient-reported information to learn about pregnancy characteristics and outcomes in women who have vasculitis, and how disease severity and pregnancy experiences relate to those outcomes.
What the researchers hope to learn. To describe pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester and postpartum; to document pregnancy experiences and self-reported vasculitis severity.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
- each woman's vasculitis severity and pregnancy-related experiences, and
- pregnancy outcomes.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Online questionnaires
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Women 18 years of age or older with one of the following diseases may take part in the study:
- Behçet's disease;
- Central nervous system (CNS) vasculitis;
- Cryoglobulinemic vasculitis (Cryoglobulinemia);
- Eosinophilic granulomatosis with polyangiitis (also called Churg-Strauss Syndrome);
- Giant Cell (Temporal) Arteritis (GCA);
- Granulomatosis with polyangiitis (also called Wegener's);
- IgA vasculitis (Henoch-Schoenlein purpura);
- Microscopic polyangiitis (MPA);
- Polyarteritis nodosa (PAN);
- Takayasu's arteritis (TAK);
- Urticarial vasculitis;
- Other/Suspected Diagnosis.
- Women must be pregnant (self-report) at the time of enrollment into the registry.
Exclusion criteria
- Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.
- Unable to provide consent.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants complete online questionnaires about their vasculitis severity, pregnancy experiences, and pregnancy outcomes at study entry, during the second trimester, during the third trimester, and postpartum. Investigators estimate each survey takes about 20 minutes, and the survey is available in Spanish, Portuguese, Italian, and Turkish. Women enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) will be invited to participate by email; survey responses are stored by the Data Management and Coordinating Center at the University of South Florida and later sent to the Study Chairs. No invasive procedures are listed—participation involves only online questionnaires and data storage as described in the registry.
How the study is structured. This is a prospective observational cohort study. Women enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) are invited by email to complete online questionnaires at enrollment, during the second trimester, during the third trimester, and postpartum. Each survey is estimated to take about 20 minutes; surveys are available in multiple languages. Survey data are stored by the Data Management and Coordinating Center at the University of South Florida and later shared with the study chairs.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Behçet's disease
This trial is also listed on this site under familial Mediterranean fever.
Important dates
- Study start
- November 2015
- Primary completion
- December 2027 (estimated)
- Study completion
- December 2027 (estimated)
- Target enrollment
- 100 participants (estimated)
- Last updated on registry
- Jan 23, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Pennsylvania
- Collaborators
- Duke University
- University of South Florida
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Christine Yeung ✉ christine.yeung@pennmedicine.upenn.edu
- Carol McAlear, MA ✉ cmcalear@upenn.edu
Participating sites (1)
- University of South Florida Data Management and Coordinating CenterRecruiting
Tampa, Florida, 33612 · United States
- Cristina Burroughs · networkmanager@vpprn.org
Terms used on this page · explanations by MedicalUpdates.ai
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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