NCT04319341

Obstetric Antiphospholipid Antibody Syndrome : Contribution of the Evaluation of ADAMTS13 Made at the Diagnosis of Pregnancy on Evaluation the Risk of Pre-eclampsia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 513 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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, ...

Conditions

• Antiphospholipid Antibody Syndrome in Pregnancy

Interventions

Type	Name	Description
OTHER	To study the prognostic value on the occurrence of pre-eclampsia, ADAMTS13 (ADAMTS13 protein and autoantibodies) in patients diagnosed with oAPS	ADAMTS13 activity, ADAMS13 antigen and anti-ADAMTS13 autoantibodies: U/ml.

Timeline

• Start date: 2020-04-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-03-24
• Last updated: 2025-12-04

Locations

1 site across 1 country: France