An observational study in Antiphospholipid Antibody Syndrome in Pregnancy, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
Study based on data concerning the first pregnancy treated and followed up after the diagnosis of oAPS in the NOH-APS cohort, according to clinical results already published; and on a thematic library collected and preserved at the time of the positive pregnancy test.
ADAMTS 13 will be explored in the available samples defined above: ADAMTS13 antigen (presence of the molecule), ADAMTS13 activity (VWF proteolysis activity of the molecule), global autoantibodies against ADAMTS13 (plasma antibodies recognizing solid phase insolubilized ADAMTS13), these 3 parameters for the description of ADAMTS13 being measured using commercially available diagnostic kits, ELISA type, Technozyme® range, Technoclone, Vienna, Austria.
The clinical endpoint evaluated will be the occurrence (yes/no) of preeclampsia, which is assessed globally, all subtypes combined. Then evaluated according to subtype: late preeclampsia from 34 weeks, early preeclampsia before 34 weeks, eclampsia (convulsions), HELLP syndrome, preeclampsia associated with the birth of a small-for-gestational-age child (defined at percentile 10 of the tables adjusted for gestational age and sex; severe: defined at percentile 3), preeclampsia associated with a retro-placental hematoma, ...
Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with an initially pure, non-thrombotic oAPS; included in the NOH-APS cohort; having been followed in Nîmes for their first pregnancy following the diagnosis of oAPS; N=513.
Exclusion Criteria:
ADAMTS13 activity, ADAMS13 antigen and anti-ADAMTS13 autoantibodies: U/ml.
The quantification, in vitro, of the activity of ADAMTS13
ADAMTS13 function, U/ml.
Time frame: at inclusion (J0)
The quantification, in vitro, of ADAMTS13 antigen
ADAMTS13 antigen, U/ml.
Time frame: at inclusion (J0)
The quantification, in vitro, of ADAMTS13 autoantibodies
ADAMTS13 autoantibodies, U/ml.
Time frame: at inclusion (J0)
Plan to share: No
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes