RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2003-09
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00198068

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Patient between the ages of 18-45 and able to give informed consent, or age \< 18 years with parental consent
  3. * Hematocrit \> 26%
  4. * For APL positive:
  5. * aCL: IgG \>= 40 GPL units; IgM \>= 40 MPL units
  6. * Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)
  7. * Anti-β2GPI: IgG \>= 40 GPL units; IgM \>= 40 MPL units
  8. * For control subjects:
  9. * At least one successful pregnancy
  10. * No history of fetal death (death of conceptus ≥ 10 weeks' gestation)
  11. * No more than 1 miscarriage \< 10 weeks' gestation
  12. * No history of positive aPL in local lab or positive aPL in core labs at screening
  13. * Not currently a smoker
  14. * No medical problems requiring chronic treatment
  1. * Diabetes mellitus (Type I and Type II) antedating pregnancy
  2. * Known or suspected hereditary complement deficiency (defined by CH50 = 0)

Contacts and Locations

Study Contact

Marta M. Guerra, MS
CONTACT
212-774-7361
guerram@hss.edu

Principal Investigator

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

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago
Chicago, Illinois, 60637
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
NYU Langone Medical Center/Hospital for Joint Diseases
New York, New York, 10016
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Columbia University Medical Center
New York, New York, 10032
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
University of Utah Salt Lake City
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

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

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

Study Start Date2003-09
Study Completion Date2025-03

Study Record Updates

Study Start Date2003-09
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy outcomes
  • Systemic lupus erythematosus
  • Antiphospholipid syndrome

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus
  • Antiphospholipid Syndrome