Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Hospital for Special Surgery, New York
- Study ID
- NCT00198068
- Status
- Recruiting
Conditions
- Antiphospholipid Syndrome
- Systemic Lupus Erythematosus
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- Sep 30, 2003
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 700 participants (estimated)
Arms
- Arm: Group 1: aPL+/SLE-Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM \>= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM \>= 40 units; no SLE
- Arm: Group 2: aPL+/SLE+Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM \>= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM \>= 40 units AND SLE defined as four or more American College of Rheumatology criteria for SLE.
- Arm: Group 3: aPL-/SLE+No antiphospholipid antibodies; SLE defined as four or more American College of Rheumatology criteria for SLE.
- Arm: Group 4: aPL-/SLE-Healthy controls: no antiphospholipid antibodies; no SLE
Primary Outcome Measure
Otherwise unexplained fetal death occurring after 12 weeks gestation [ Time Frame: End of pregnancy ]
Central Contacts
- Marta M. Guerra, MS212-774-7361
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | - |
| University of Chicago | Chicago | Illinois | 60637 | - |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | - |
| Columbia University Medical Center | New York | New York | 10032 | - |
| Hospital for Special Surgery | New York | New York | 10021 | Michael D. Lockshin, M.D. (PRINCIPAL_INVESTIGATOR) Lisa R. Sammaritano, M.D. (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Medical Center/Hospital for Joint Diseases | New York | New York | 10016 | Jill P. Buyon, M.D. (PRINCIPAL_INVESTIGATOR) |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | - |
| University of Utah Salt Lake City | Salt Lake City | Utah | 84132 | Ware Branch, M.D. (PRINCIPAL_INVESTIGATOR) Flint Porter, M.D. (PRINCIPAL_INVESTIGATOR) |
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