Predicting pregnancy outcomes in women with lupus and antiphospholipid syndrome
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Hospital for Special Surgery, New York · NCT00198068
This study is trying to see if certain proteins can help predict pregnancy outcomes for women with lupus and antiphospholipid syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Hospital for Special Surgery, New York (other) |
| Locations | 10 sites (Chicago, Illinois and 9 other locations) |
| Trial ID | NCT00198068 on ClinicalTrials.gov |
What this trial studies
This observational study involves 700 pregnant patients across nine major clinical centers, focusing on the role of specific proteins and factors in predicting pregnancy outcomes for women with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS). The study aims to determine if complement split products and circulating antiangiogenic factors can forecast complications during pregnancy. By translating findings from animal models to human subjects, the research seeks to enhance understanding of how these factors contribute to pregnancy loss and other complications in affected women.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18-45 with live intrauterine pregnancies and specific antibody profiles related to SLE and APS.
Not a fit: Patients with diabetes mellitus or significant medical problems requiring chronic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and management of pregnancy complications in women with SLE and APS.
How similar studies have performed: Previous studies have shown promising results in understanding the role of angiogenic factors in pregnancy outcomes, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Chicago, Illinois and 9 other locations
- Northwestern University — Chicago, Illinois, United States (COMPLETED)
- University of Chicago — Chicago, Illinois, United States (COMPLETED)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (COMPLETED)
- NYU Langone Medical Center/Hospital for Joint Diseases — New York, New York, United States (RECRUITING)
- Hospital for Special Surgery — New York, New York, United States (RECRUITING)
- Columbia University Medical Center — New York, New York, United States (COMPLETED)
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (COMPLETED)
- University of Utah Salt Lake City — Salt Lake City, Utah, United States (RECRUITING)
- Mt. Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
- Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom (COMPLETED)
Study contacts
- Principal investigator: Jane E. Salmon, M.D. — Hospital for Special Surgery, New York
- Study coordinator: Marta M. Guerra, MS
- Email: guerram@hss.edu
- Phone: 212-774-7361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Systemic Lupus Erythematosus, Antiphospholipid Syndrome, Pregnancy outcomes, Systemic lupus erythematosus, Antiphospholipid syndrome