The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and/or 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and/or SLE.
Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)
Patient between the ages of 18-45 and able to give informed consent, or age < 18 years with parental consent
Hematocrit > 26%
aCL: IgG >= 40 GPL units; IgM >= 40 MPL units
Diabetes mellitus (Type I and Type II) antedating pregnancy
Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Hospital for Special Surgery, New York
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator