The Vasculitis Pregnancy Registry (V-PREG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Unique pregnancy characteristics among women with vasculitis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.
- •Unable to provide consent.
研究组 & 干预措施
Intervention
Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.
干预措施: Online questionnaires (Other)
结局指标
主要结局
Unique pregnancy characteristics among women with vasculitis.
时间窗: Four years
To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.
次要结局
未报告次要终点