This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The hypothesis of this multicenter trial is that antiphospholipid (aPL)-positive patients' risk of thrombosis and pregnancy loss requires complement activation. A total of 400 patients (65 at NYU/HJD) will be followed during pregnancy and analyzed according to presence or absence of aPL antibodies. The objective is to determine surrogate markers of fetal loss in a longitudinal study in which monthly serological assays are determined. The primary outcomes are 1) fetal or neonatal death and 2) preterm delivery due to pre-eclampsia or placental insufficiency. The secondary outcome is systemic lupus erythematosus (SLE) flares. The significance of this study is that it will determine which specific complement measure increases risk of poor outcome. Recruitment has begun on this study. Results are not yet available.
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