Maternal Autoimmune Disease Research Alliance (MADRA) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.
研究概览
简要总结
This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases.
The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy.
Prior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. The future research will seek to better define these risk factors and to identify ways to may improve them.
详细描述
At each site, the patients will be under the care of the participating rheumatologist and their local obstetrician during the pregnancy. This is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care.
Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician. Enrollment in the registry will not dictate specific therapy. The Registry will include data from each office visit during pregnancy and up to 12 months after delivery.
The registry will be ongoing, with periodic analysis of clinical data samples as specific studies are approved.
Enrollment in the registry does not significantly increase risks for a patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
结局指标
主要结局
Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.
时间窗: up to 10 years
The investigators will ask the participants questions from the MADRA-DAP questionnaire to determine poor pregnancy outcomes.
次要结局
未报告次要终点