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Predictors of Pregnancy Outcome in Lupus (SLE) and Antiphospholipid Syndrome (APS)
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.
Conditions:
🦠 Systemic Lupus Erythematosus 🦠 Antiphospholipid Syndrome
🗓️ Study Start (Actual) September 2003
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 700
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Baltimore, Maryland, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Oklahoma City, Oklahoma, United States
📍 Salt Lake City, Utah, United States
📍 Toronto, Ontario, Canada
📍 London, United Kingdom
More locations available...

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 September 2005
  • First Submitted that Met QC Criteria 12 September 2005
  • First Posted 20 September 2005

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 April 2024
  • Last Update Posted 8 April 2024
  • Last Verified April 2024
I'm interested ...!!