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

Recruiting now

Conditions studied: Systemic Lupus Erythematosus, Antiphospholipid Syndrome

In brief

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.

Key facts

Study ID

NCT00198068

Run by

Hospital for Special Surgery, New York

People needed

700

Starts

2003-09-01

Expected to finish

2027-03-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Hospital for Special Surgery — New York, New York, United States (enrolling)
• University of Utah Salt Lake City — Salt Lake City, Utah, United States (enrolling)
• Mt. Sinai Hospital — Toronto, Ontario, Canada (enrolling)
• NYU Langone Medical Center/Hospital for Joint Diseases — New York, New York, United States (enrolling)
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Northwestern University — Chicago, Illinois, United States
• Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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