Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Eligible age
18–45 yrs
Accepts
Women
Locations
5 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
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.
Sponsor: Hospital for Special Surgery, New York
You may qualify if…
- ✓ 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:
You may not qualify if…
- ✕ Diabetes mellitus (Type I and Type II) antedating pregnancy
- ✕ Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Where it's recruiting
Source: ClinicalTrials.gov · NCT00198068 · last updated 2026-04-28