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

Hospital for Special Surgery, New York · with National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NCT00198068

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
700
US sites recruiting
3
Study start
September 2003
Record last updated
April 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • NYU Langone Medical Center/Hospital for Joint Diseases

    New York, NY 10016

    Site contact: Marta M Guerra, MS · 212-774-7361 · guerram@hss.edu

  • Hospital for Special Surgery

    New York, NY 10021

    Site contact: Marta M Guerra, MS · 212-774-7361 · guerram@hss.edu

  • University of Utah Salt Lake City

    Salt Lake City, UT 84132

    Site contact: Tyler R Cavin · 801-585-7617 · tyler.cavin@hsc.utah.edu

Study contacts (from the official record)

  • Marta M. Guerra, MS · 212-774-7361 · guerram@hss.edu
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Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus… (NCT00198068) | Bored Studies