Duke Autoimmunity in Pregnancy Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 513
- 试验地点
- 1
研究概览
简要总结
It is difficult to predict how a women with an autoimmune disease will do during pregnancy. Some women will improve, others will worsen. Some pregnancies progress normally and others become very complicated.
The Duke Autoimmunity in Pregnancy (DAP) Registry will enroll women with autoimmune diseases, such as lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome who wish to become, or already are, pregnant. We will follow these women throughout pregnancy to better understand how their autoimmune disease affects their pregnancy, and vice versa.
详细描述
Women with a systemic autoimmune disease that would be followed by a rheumatologist will be included in this study.
All women will be seen every 4-6 weeks throughout pregnancy. At each visit, women will complete a questionnaire, the physician will determine the current level of disease activity, and a blood sample will be taken. For women with lupus and healthy women, and additional visit will occur at the start of the 3rd trimester for a closer evaluation of predictors of preterm birth.
This is not an intervention study. Women will not be given experimental medication. All recommendations for treatment and monitoring will be made based on the best available data with input from the treating obstetrician.
Women in this Registry are not required to be seen by Duke Obstetrics nor to deliver at a Duke Hospital.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Desire for pregnancy within 6 months or currently pregnant
- •Women with systemic autoimmune disease, including:
- •Lupus (systemic lupus erythematosus or cutaneous lupus)
- •Antiphospholipid Syndrome or positive antiphospholipid antibodies
- •Rheumatoid Arthritis
- •Scleroderma (systemic sclerosis)
- •Sjogren's Syndrome
- •Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)
- •Undifferentiated Connective Tissue Disease (UCTD)
- •Vasculitis
- •Myositis (Polymyositis or Dermatomyositis)
- •Positive Ro/SSA or La/SSB antibodies
排除标准
- •Unable to speak English
- •Unable to provide informed consent
- •Unable to travel to Duke University for follow-up visits