Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

February 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004663 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus

Official Title ^ICMJE

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Longitudinal

Condition ^ICMJE

Systemic Lupus Erythematosus

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

480

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004663

Responsible Party

Study ID Numbers ^ICMJE

199/11926, NU-501

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

Rosalind Ramsey-Goldman

Northwestern University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

July 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP