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Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus - Article


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Systemic Lupus Erythematosus

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Clinical Trial: Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Northwestern University
Information provided by: Office of Rare Diseases (ORD)

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

Further Study Details: 

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


Location Information

Study chairs or principal investigators

Rosalind Ramsey-Goldman,  Study Chair,  Northwestern University   

More Information

Study ID Numbers:  199/11926; NU-501
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

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November 24, 2009



Page Updated: October 15, 2009
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