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

Recruitingn/aAges 18 Years - 45 YearsFemaleHospital for Special Surgery, New York
NCT00198068 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated ฮฒ-HCG, but โ‰ค 12 weeks by gestation (for subjects without aPL antibodies) and โ‰ค18 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-ฮฒ2GPI: IgG \>= 40 GPL units; IgM \>= 40 MPL units * For control subjects: * At least one successful pregnancy * No history of fetal death (death of conceptus โ‰ฅ 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)
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What it tests

  • Not listed
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Where

10 sites
Northwestern University
Chicago, United States
University of Chicago
Chicago, United States
Johns Hopkins Hospital
Baltimore, United States
NYU Langone Medical Center/Hospital for Joint Diseases
New York, United States
Hospital for Special Surgery
New York, United States
Columbia University Medical Center
New York, United States
Oklahoma Medical Research Foundation
Oklahoma City, United States
University of Utah Salt Lake City
Salt Lake City, United States

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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