Understanding pregnancy complications in lupus and antibody disorders

Plain-English translation of NCT00198068 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

This research study is trying to understand why some pregnant women with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS) — conditions where the immune system attacks the body — have higher rates of miscarriage and pregnancy complications. By following 700 pregnant women and collecting blood samples throughout pregnancy, researchers hope to identify early warning signs that could help predict and prevent these problems.

Current treatments help some women with these conditions, but doctors don't fully understand why pregnancy loss happens or how to reliably predict which women will have complications. Animal studies suggest that certain immune factors called complement proteins play a role, but this hasn't been proven in pregnant women yet. This study aims to translate those discoveries into real-world guidance for patient care.

Do you qualify?

You likely qualify if…

you are pregnant and between 18–45 years old (or under 18 with parental consent)
you are in early pregnancy (12 weeks or less if you don't have antiphospholipid antibodies; 18 weeks or less if you do)
you have a healthy blood count (hematocrit above 26%)
you have a confirmed diagnosis of lupus or antiphospholipid antibodies, or you are a healthy control with at least one successful prior pregnancy and no history of blood clotting antibodies

You likely don't qualify if…

you have diabetes (type 1 or type 2) that existed before this pregnancy
you have a known hereditary complement deficiency
you are a control participant and have had a fetal death after 10 weeks of pregnancy, or more than one miscarriage before 10 weeks
you currently smoke
you have medical conditions that require ongoing treatment (for control participants only)

What participation looks like

You would visit the research clinic regularly throughout your pregnancy for standard obstetrical care and monitoring. At each visit, you'll have blood drawn to measure immune markers and other factors that may predict pregnancy outcomes. The study follows you and your baby from early pregnancy through delivery. You'll also share your medical history and pregnancy information with the research team. This is an observational study, meaning researchers are watching and learning from your pregnancy rather than testing a new medication.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(10 sites)

United States

Northwestern University, Chicago, Illinois

University of Chicago, Chicago, Illinois

Johns Hopkins Hospital, Baltimore, Maryland

NYU Langone Medical Center/Hospital for Joint Diseases, New York, New York

Hospital for Special Surgery, New York, New York