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

Sponsored by Hospital for Special Surgery, New York

Phase Quota
Phase N/A

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.

Study Start Date: September 2003

Estimated Completion Date: August 2016

Specialties: Rheumatology: Systemic Lupus (SLE) Obstetrics & Gynecology: Maternal Fetal Medicine Physician Assistant: Obstetrics/Gynecology,Rheumatology

Interventions

No interventions cited

Inclusion criteria

  • Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated ß-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-ß2GPI: 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
  • Multiple fetal gestations
  • Known or suspected hereditary complement deficiency (defined by CH50 = 0)

Study Locations And Contact Information

  • University of Utah Salt Lake City, Salt Lake City Utah
    Contact: Samantha Nielsen BS 801-585-7617 sam.nielsen@hsc.utah.edu
  • NYU Langone Medical CenterHospital for Joint Diseases, New York New York
    Contact: Marta M Guerra MS 212-774-7361 guerram@hss.edu
  • NYU Langone Medical CenterHospital for Joint Diseases, New York New York
  • Northwestern University, Chicago Illinois
  • University of Chicago, Chicago Illinois
  • University of Utah Salt Lake City, Salt Lake City Utah
  • Johns Hopkins Hospital, Baltimore Maryland
  • Guys St Thomas NHS Foundation Trust, London
  • Oklahoma Medical Research Foundation, Oklahoma City Oklahoma
  • Guys St Thomas NHS Foundation Trust, London
  • Mt Sinai Hospital, Toronto Ontario
  • Hospital for Special Surgery, New York New York
  • University of Chicago, Chicago Illinois
  • Columbia University Medical Center, New York New York

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