Systemic Lupus Erythematosus |
Sle |
Clinical Trial: Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus
This study has been completed.
|
Purpose
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.
| Condition |
|---|
| Systemic Lupus Erythematosus |
MedlinePlus related topics: Lupus
Study Type: Observational
Study Design: Screening, Longitudinal
Expected Total Enrollment: 480
Study start: 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.
Eligibility
Ages Eligible for Study: 18 Years - 50 Years, Genders Eligible for Study: Female
Criteria
- Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria
Location Information
Rosalind Ramsey-Goldman, Study Chair, Northwestern University
More Information
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: February 24, 2000
ClinicalTrials.gov Identifier: NCT00004663
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Autoimmune Diseases (Cleveland Clinic)
- Lupus (HealthWorld)

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