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)
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|ClinicalTrials.gov Identifier: NCT04319341|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
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, ...
|Condition or disease||Intervention/treatment|
|Antiphospholipid Antibody Syndrome in Pregnancy||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|
|Estimated Enrollment :||513 participants|
|Official Title:||Obstetric Antiphospholipid Antibody Syndrome : Contribution of the Evaluation of ADAMTS13 Made at the Diagnosis of Pregnancy on Evaluation the Risk of Pre-eclampsia|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||July 30, 2020|
- 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.
- The quantification, in vitro, of the activity of ADAMTS13 [ Time Frame: at inclusion (J0) ]ADAMTS13 function, U/ml.
- The quantification, in vitro, of ADAMTS13 antigen [ Time Frame: at inclusion (J0) ]ADAMTS13 antigen, U/ml.
- The quantification, in vitro, of ADAMTS13 autoantibodies [ Time Frame: at inclusion (J0) ]ADAMTS13 autoantibodies, U/ml.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319341
|Contact: Jean-Christophe GRIS||04.66.68.32.11||Jean.firstname.lastname@example.org|
|CHU de Nîmes - Hôpital Universitaire Carémea|
|Nîmes Cedex 09, France, 30029|