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Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004663
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: July 2004
History of Changes
  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

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Longitudinal

Resource links provided by NLM:

U.S. FDA Resources

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

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

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 13, 2013