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

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.

Conditions

Systemic Lupus Erythematosus, Antiphospholipid Syndrome

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

New York

NYU Langone Medical Center/Hospital for Joint Diseases, New York, New York, United States, 10016

New York

Hospital for Special Surgery, New York, New York, United States, 10021

New York

Columbia University Medical Center, New York, New York, United States, 10032

Oklahoma City

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States, 73104

Salt Lake City

University of Utah Salt Lake City, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Hospital for Special Surgery, New York,

Jane E. Salmon, M.D., PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

2025-03