Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Collaborators:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 30, 2014