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

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Sep 12, 2005

Keywords

ClinConnect Summary

The PROMISSE Study is looking at how certain proteins in the body can help predict pregnancy outcomes for women who have systemic lupus erythematosus (SLE) or antiphospholipid syndrome (APS). The research involves 700 pregnant women from nine major medical centers. Specifically, the study aims to see if levels of specific proteins, which can harm healthy organs, and other substances in the blood can indicate whether a pregnancy might have complications.

To participate in this study, women need to be between the ages of 18 and 45, and they must be pregnant with a live baby, at an early stage of pregnancy (up to 12 weeks if they don't have aPL antibodies, or up to 18 weeks if they do). Participants should also have a good level of hemoglobin in their blood and meet specific health criteria. Women who join the study can expect to be monitored closely throughout their pregnancy, and their health will be compared to those who have had successful pregnancies without complications. This research is important because it could lead to better care and outcomes for women with these conditions during pregnancy.

Gender

FEMALE

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)