Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-02-28

Brief Summary

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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

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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.

Conditions

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Systemic Lupus Erythematosus

Keywords

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arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus

Study Design

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Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Rosalind Ramsey-Goldman

Role: STUDY_CHAIR

Northwestern University

Other Identifiers

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NU-501

Identifier Type: -

Identifier Source: secondary_id

199/11926