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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Antiphospholipid Antibody Syndrome in Pregnancy

Treatments: Other: To study the prognostic value on the occurrence of pre-eclampsia, ADAMTS13 (ADAMTS13 protein and autoantibodies) in patients diagnosed with oAPS

Study type: Observational

Funder types: Other

Identifiers

NCT04319341

Local/2020/JCG-01

Details and patient eligibility

About

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, ...

Enrollment: 513 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of frozen plasma samples from the positive pregnancy test blood sample.
• Adult patients, included in the NOH-APS cohort, who have successfully initiated a new pregnancy after diagnosis of oAPS.

Exclusion criteria

• Absence of frozen plasma sample from the blood sample from the positive pregnancy test.
• Patient who objected to the use of their data.