Predicting pregnancy outcomes in women with lupus and antiphospholipid syndrome
Official title: Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Run by Hospital for Special Surgery, New York · NCT00198068 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 700 (estimated) |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 10 sites (Chicago, Illinois and 9 other locations) |
| Status | Recruiting |
| Started | September 2003 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT00198068 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women aged 18-45 with live intrauterine pregnancies and specific antibody profiles related to SLE and APS.
✕Probably not a fit
Patients with diabetes mellitus or significant medical problems requiring chronic treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results in understanding the role of angiogenic factors in pregnancy outcomes, suggesting that this approach may yield valuable insights.
Who can join: the full rules
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 it's running
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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 -
University of Utah Salt Lake City
Salt Lake City, Utah, United States Recruiting -
Mt. Sinai Hospital
Toronto, Ontario, Canada Recruiting -
Northwestern University
Chicago, Illinois, United States Completed -
University of Chicago
Chicago, Illinois, United States Completed
Show 4 more locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States Completed -
Columbia University Medical Center
New York, New York, United States Completed -
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States Completed -
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.