NCT00513591

Duke Autoimmunity in Pregnancy Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 513 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pregnancy
• Systemic Lupus Erythematosus
• Cutaneous Lupus
• Rheumatoid Arthritis
• Sjogren's Syndrome
• Scleroderma

Timeline

• Start date: 2007-08-01
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2007-08-08
• Last updated: 2019-10-23

Locations

1 site across 1 country: United States