NCT00198068Recruiting
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 12 Sept 2005
- Start date
- Sept 2003
- Primary completion date
- Mar 2027
- Lead sponsor
- Hospital for Special Surgery, New York
- Diseases
- Lupus (SLE)
- NCT number
- NCT00198068
What you commit to
- Study type: Observational
- Planned participants: 700
- From Sept 2003 to the primary completion date, Mar 2027
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes mellitus (Type I and Type II) antedating pregnancy
Other
- Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mt Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Guy's & St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Completed |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Completed |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Completed |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Completed |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Completed |
| NYU Langone Medical Center/Hospital for Joint Diseases Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Hospital for Special Surgery Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Oklahoma Medical Research Foundation Coordinator of this site? Confirm its status | Oklahoma City | United States | Completed |
| University of Utah Salt Lake City Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.