Evaluation of Pregnancy Outcomes in Women with Systemic Lupus Erythematosus
Data Collection
Autoimmune Diseases+11
+ Infections
+ Joint Diseases
Summary
Study start date: February 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.480 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria