Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Sponsored by Hospital for Special Surgery, New York
About this study
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.
Thrombosis and pregnancy loss are common features of systemic lupus erythematosus (SLE), particularly in the presence of antiphospholipid (aPL) antibodies. The in vivo mechanisms by which aPL antibodies lead to vascular events and, specifically, to recurrent fetal loss are largely unknown. Studies in a mouse model of antiphospholipid antibody syndrome (APS) indicate that in vivo complement activation is necessary for fetal loss caused by aPL antibodies. This study represents an effort to translate these research observations on the potential role of complement activation in the pathogenesis of aPL antibody-mediated pregnancy loss to a clinically relevant human study. In addition, studies in humans and mice have shown 1) that the balance of circulating angiogenic and antiangiogenic factors…
Where this study is enrolling (3)
- I'm interested
Hospital for Special Surgery
New York, New York
- I'm interested
NYU Langone Medical Center/Hospital for Joint Diseases
New York, New York
- I'm interested
University of Utah Salt Lake City
Salt Lake City, Utah
Who can participate
Inclusion criteria
- ✓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%
- ✓For APL positive:
- ✓aCL: IgG \>= 40 GPL units; IgM \>= 40 MPL units
- ✓Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)
- ✓Anti-β2GPI: IgG \>= 40 GPL units; IgM \>= 40 MPL units
- ✓For control subjects:
- ✓At least one successful pregnancy
- ✓No history of fetal death (death of conceptus ≥ 10 weeks' gestation)
- ✓No more than 1 miscarriage \< 10 weeks' gestation
- ✓No history of positive aPL in local lab or positive aPL in core labs at screening
- ✓Not currently a smoker
- ✓No medical problems requiring chronic treatment
Exclusion criteria
- ✕Diabetes mellitus (Type I and Type II) antedating pregnancy
- ✕Known or suspected hereditary complement deficiency (defined by CH50 = 0)
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Trial data sourced from ClinicalTrials.gov.