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Taking people in CanadaNo phase

Studies pregnancy outcomes in people with lupus or antiphospholipid syndrome

Observes pregnant adults with lupus or antiphospholipid syndrome to see what predicts pregnancy problems.

Plain-language title generated from the registry record
Registry title: Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)

Key facts

Where
Toronto, CanadaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 45 years old?

Source: NCT00198068, who can take part

Where in Canada

  • Mt Sinai HospitalToronto, CanadaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Hospital for Special Surgery, New York
Trial code
NCT00198068
Record updated
28 April 2026
Original description
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.Read full original descriptionShow less

Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (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.

Inclusion: 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: Diabetes mellitus (Type I and Type II) antedating pregnancy; Known or suspected hereditary complement deficiency (defined by CH50 = 0).

ClinicalTrials.gov NCT00198068