Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- National Center for Research Resources (NCRR)
- Enrollment
- 480
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified