Trial Information

Summary: The PROMISSE Study: (Predictors of pRegnancy Outcome: bioMarkers In antiphospholipid Syndrome and Systemic lupus Erthematosus)

This trial is supported by the National Institutes of Health and the University of Chicago’s National Institute of Health (NIH) General Clinical Research Center (GCRC).

The antiphospholipid syndrome (APS) and systemic lupus erythematosus (SLE) are associated with problems in pregnancy. It is not known why these problems occur or how they can be prevented. The University of Chicago and Dr. Mary Stephenson, as well as other investigators at seven other major clinical centers around the U.S. and Canada, are conducting a clinical study to find out whether increased amounts of certain proteins in the blood that can injure healthy organs can be used to predict whether or not pregnant women with APS and/or SLE will have a healthy pregnancy.

If you decide to participate you will be involved in the study from approximately 6 weeks of pregnancy until approximately 3 months post partum. If it is determined that you are eligible, you would

• Have research blood and urine tests done every 4-6 weeks in pregnancy
• If you have SLE, you would have a research assessment for disease activity 3 times during pregnancy and once post partum

There will be no charge for the study-related procedures. The cost of routine care prior to, during, and after pregnancy will be the participant’s responsibility.

The benefits of participating in this trial include the possibility of helping Dr. Stephenson and her colleagues better understand how problems in pregnant women with APS and/or SLE occur. If the investigators find that inflammatory proteins in blood predict problems in pregnancy, then such blood tests may be used to predict complications in other pregnant patients with APS and SLE. The result of this study may also lead to better treatments for pregnancy loss in such women.

Participation Details
Initial selection criteria for the study include:

• 18 - 45 years of age
• Less than 3 months pregnant
• Presence of antiphospholipid antibodies and/or systemic lupus erythematosus

Study Director: Mary D. Stephenson, MD, MSc
Department: Obstetrics and Gynecology, Reproductive Endocrinology & Infertility

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Trial listings updated: June 1, 2008 at 5:45:17 AM