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

Completed

• Conditions: Antiphospholipid Antibody Syndrome in Pregnancy

• Registration Number: NCT04319341
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 (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, ...

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Study Start: 2020-04-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 513

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The quantification, in vitro, of the activity of ADAMTS13	at inclusion (J0)	ADAMTS13 function, U/ml.
The quantification, in vitro, of ADAMTS13 antigen	at inclusion (J0)	ADAMTS13 antigen, U/ml.
The quantification, in vitro, of ADAMTS13 autoantibodies	at inclusion (J0)	ADAMTS13 autoantibodies, U/ml.

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémea; 🇫🇷 Nîmes Cedex 09, France