NCT00198068 · Hospital for Special Surgery, New York
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
(PROMISSE)
What this study is about
The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
- Baltimore, Maryland
- New York, New York
- Oklahoma City, Oklahoma
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations