NCT00198068 Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
| NCT ID | NCT00198068 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2003-09 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2003-09 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Jane E. Salmon, M.D.
PRINCIPAL INVESTIGATOR
Hospital for Special Surgery, New York
Frequently Asked Questions
Who can join the NCT00198068 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00198068 currently recruiting?
Yes, NCT00198068 is actively recruiting participants. Contact the research team at guerram@hss.edu for enrollment information.
Where is the NCT00198068 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Baltimore, United States, New York, United States and 6 additional locations.
Who is sponsoring the NCT00198068 clinical trial?
NCT00198068 is sponsored by Hospital for Special Surgery, New York. The principal investigator is Jane E. Salmon, M.D. at Hospital for Special Surgery, New York. The trial plans to enroll 700 participants.
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