Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Recruiting · NCT00198068 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospital for Special Surgery, New York
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
10 locations listed across 5 US states.
- Northwestern University - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- NYU Langone Medical Center/Hospital for Joint Diseases - New York, New York, United States
- Hospital for Special Surgery - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Oklahoma Medical Research Foundation - Oklahoma City, Oklahoma, United States
- University of Utah Salt Lake City - Salt Lake City, Utah, United States
- Guy's & St Thomas' NHS Foundation Trust - London, United Kingdom
- Mt. Sinai Hospital - Toronto, Ontario, Canada