Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

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)
ClinicalTrials.gov Identifier:	NCT00004663

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	480
Study Start Date:	February 1994

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004663

Sponsors and Collaborators

National Center for Research Resources (NCRR)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Northwestern University

Investigators

Study Chair:

Rosalind Ramsey-Goldman

Northwestern University

More Information

No publications provided

Study ID Numbers:	199/11926, NU-501
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004663 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

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

Study placed in the following topic categories:

Autoimmune Diseases
Lupus Erythematosus, Systemic
Lupus

Arthritis
Rare Diseases
Connective Tissue Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009