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Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)

Systemic Lupus Erythematosus | Antiphospholipid Syndrome

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.

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Participation Requirements

  • Sex:

    FEMALE

  • Eligible Ages:

    18 to 45

Participation Criteria

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)

Study Location

Mt. Sinai Hospital
Mt. Sinai Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Karen Spitzer

[email protected]
416-506-9203
Study Sponsored By
Hospital for Special Surgery, New York
Participants Required
More Information
Study ID: NCT00198068