PROMISSE: Predictors of Pregnancy Outcome: Biomarkers in Anti-Phospholipid Antibody Syndrome (APS) and Systemic Lupus Erythematosus (SLE)

February 27, 2018

Institutional Review Board, Hospital for Special Surgery

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Principal Investigator

Jane E. Salmon, MD

Co-Investigators

Michael Lockshin, MD
Lisa Sammaritano, MD

Summary

 

The study objective is to define predictors of outcome in pregnant patients with Systemic Lupus Erythematosus (SLE) and/or anti-phospholipid antibodies (APL). During the course of pregnancy, we collect monthly clinical data along with serial blood and urine specimens. As of January 1, 2018,  more than 700 participants have been enrolled into this multi-center observational study.

 

Inclusion/Exclusion Criteria

Inclusion Criteria

Participants must have an unequivocal diagnosis of SLE (satisfying 4 or more American College of Rheumatology criteria for SLE), APL (positive for anti-ß2 GPI, aCL and/or LAC), or both conditions. Additionally, the patient must meet the following criteria:

• Pregnant as defined by positive test for elevated ß-HCG
• Live single intrauterine pregnancy at less than 12 weeks’ gestation
• 18-45 years of age and able to give informed consent, or a minor with parental consent
• Hematocrit greater than 26%

Exclusion Criteria

Patients with any of the following criteria are ineligible for participation:

• Prednisone > 20mg/day
• Renal disease:
• Proteinuria > 1000mg/24 hr
• RBC casts
• Serum creatinine >1.2 mg/dl
• Diabetes mellitus (Type I and Type II) antedating pregnancy
• Hypertension BP > 140/90
• Multiple fetal gestations

Contact Information

Project Coordinator
Marta M. Guerra, M.S.
guerram@hss.edu
212.774.7361

Research Coordinator
Haley Slosberg
slosbergh@hss.edu
212.774.2223