Vasculitis Pregnancy Registry (V-PREG)
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| ClinicalTrials.gov Identifier: NCT02593565 |
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Recruitment Status :
Recruiting
First Posted : November 1, 2015
Last Update Posted : May 18, 2022
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| 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 |
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] |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | The Vasculitis Pregnancy Registry (V-PREG) |
| Study Start Date : | November 2015 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Intervention
Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.
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Other: Online questionnaires
Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire. |
- 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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593565
| Contact: Christine Yeung | christine.yeung@pennmedicine.upenn.edu | ||
| Contact: Carol McAlear, MA | cmcalear@upenn.edu |
| United States, Florida | |
| University of South Florida Data Management and Coordinating Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Cristina Burroughs networkmanager@vpprn.org | |
| Study Chair: | Megan Clowse, MD, MPH | Duke University | |
| Study Chair: | Peter A Merkel, MD, MPH | University of Pennsylvania |
Publications:
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT02593565 |
| Other Study ID Numbers: |
VCRC 5532 |
| First Posted: | November 1, 2015 Key Record Dates |
| Last Update Posted: | May 18, 2022 |
| Last Verified: | May 2022 |
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Vasculitis, Central Nervous System Vasculitis Systemic Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Behcet Syndrome Granulomatosis with Polyangiitis Microscopic Polyangiitis Arteritis Takayasu Arteritis Aortic Arch Syndromes Purpura, Schoenlein-Henoch Churg-Strauss Syndrome Polyarteritis Nodosa Purpura Blood Coagulation Disorders |
Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Vascular Diseases Cardiovascular Diseases Mouth Diseases Stomatognathic Diseases Uveitis, Anterior Panuveitis Uveitis Uveal Diseases Eye Diseases Hereditary Autoinflammatory Diseases Genetic Diseases, Inborn |