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
- each woman's vasculitis severity and pregnancy-related experiences, and
- pregnancy outcomes.
|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)|
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02593565
|United States, Florida|
|University of South Florida Data Management and Coordinating Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Cristina Burroughs firstname.lastname@example.org|
|Study Chair:||Megan Clowse, MD, MPH||Duke University|
|Study Chair:||Peter A Merkel, MD, MPH||University of Pennsylvania|