Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04319341
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2020-03-19
Brief Title:
Obstetric Antiphospholipid Antibody Syndrome Contribution of the Evaluation of ADAMTS13 Made at the Diagnosis of Pregnancy on Evaluation the Risk of Pre-eclampsia
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOH-ADAMTS
Brief 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 yesno 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
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 yesno 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None