Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004663|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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 or disease|
|Systemic Lupus Erythematosus|
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.
|Study Type :||Observational|
|Estimated Enrollment :||480 participants|
|Study Start Date :||February 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004663
|Study Chair:||Rosalind Ramsey-Goldman||Northwestern University|