Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
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.
Systemic Lupus Erythematosus
|Study Design:||Primary Purpose: Screening
Time Perspective: Longitudinal
|Study Start Date:||February 1994|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004663
|Study Chair:||Rosalind Ramsey-Goldman||Northwestern University|