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Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus



Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus

For Condition: Systemic Lupus Erythematosus
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),Northwestern University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Observational, Screening, Longitudinal
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Female
Protocol Entry Criteria: - Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria
Total Enrollment: 480

Location and Contact Information:

Overall Study Official:
RosalindRamsey-Goldman,  Study Chair,  Northwestern University


Additional Information:
Study ID Numbers:  199/11926;  NU-501
Study Start Date: February 1994
Record last reviewed: February 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004663

Other Systemic Lupus Erythematosus Studies:
1. Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus

2. Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders

3. Drug Therapy in Lupus Nephropathy

4. Monoclonal Antibody Treatment for Systemic Lupus Erythematosus

5. Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture

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