Systemic Lupus Erythematosus
Conditions
Keywords
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Northwestern University
National Center for Research Resources (NCRR)
Study design
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria
Outcome results
None listed