Status:
RECRUITING
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Systemic Lupus Erythematosus
Antiphospholipid Syndrome
Eligibility:
FEMALE
18-45 years
Brief Summary
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 ...
Detailed Description
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 antibodi...
Eligibility Criteria
Inclusion
- 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
- Diabetes mellitus (Type I and Type II) antedating pregnancy
- Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00198068
Start Date
September 1 2003
End Date
March 1 2026
Last Update
April 13 2025
Active Locations (10)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
4
NYU Langone Medical Center/Hospital for Joint Diseases
New York, New York, United States, 10016