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| ID | Type | Description | Link |
|---|---|---|---|
| NU-501 |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| Northwestern University | OTHER |
OBJECTIVES: I. Evaluate whether pregnancy is an independent risk factor that affects disease activity in women with systemic lupus erythematosus.
II. Evaluate whether maternal disease activity is a risk factor for adverse pregnancy outcome.
PROTOCOL OUTLINE: This is a case-controlled study. Intensive data collection begins when a patient becomes pregnant.
Pregnant women are evaluated with interval pregnancy/exposure history and a clinical exam, including the Systemic Lupus Activity Measure (SLAM). Assessments are scheduled every 3 months as follows: visit 1 when the pregnancy is confirmed, visit 2 during the second trimester, visit 3 during the third trimester, visit 4 at 3 months postpartum, and visit 5 at 6 months postpartum. Visits 4 and 5 include an infant exam for growth and morphologic parameters; these visits occur on the same schedule if there is a miscarriage or stillbirth.
Patients not currently pregnant are randomly chosen to be followed as controls. These patients undergo a review of current pregnancy status and measures of disease activity, including SLAM, every 3 months for 5 visits.
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| Name | Affiliation | Role |
|---|---|---|
| Rosalind Ramsey-Goldman | Northwestern University | Study Chair |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001168 | Arthritis |
| D003240 | Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D003141 | Communicable Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |