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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Women with lupus | ||
| 2 | Health women who are matched to women with lupus by age and race | ||
| 3 | Women with other autoimmune diseases |
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Inclusion Criteria:
18 years of age or older
Desire for pregnancy within 6 months or currently pregnant
Women with systemic autoimmune disease, including:
Exclusion Criteria:
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Pregnant women with autoimmune disease.
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| Name | Affiliation | Role |
|---|---|---|
| Megan E. B. Clowse, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| Label | URL |
|---|---|
| The Duke Lupus Clinic website | View source |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| D012859 | Sjogren's Syndrome |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Blood samples will be collected and stored for future analysis.
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012595 | Scleroderma, Systemic |
| D012871 | Skin Diseases |