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)

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, ...

Study Overview

• Status: Completed
• Conditions: Antiphospholipid Antibody Syndrome in Pregnancy
• Intervention / Treatment: 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
• Enrollment (Actual): 513

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes - Hôpital Universitaire Carémea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with an initially pure, non-thrombotic oAPS; included in the NOH-APS cohort; having been followed in Nîmes for their first pregnancy following the diagnosis of oAPS; N=513.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quantification, in vitro, of the activity of ADAMTS13	ADAMTS13 function, U/ml.	at inclusion (J0)
The quantification, in vitro, of ADAMTS13 antigen	ADAMTS13 antigen, U/ml.	at inclusion (J0)
The quantification, in vitro, of ADAMTS13 autoantibodies	ADAMTS13 autoantibodies, U/ml.	at inclusion (J0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Bitsadze V, Bouvier S, Khizroeva J, Cochery-Nouvellon E, Mercier E, Perez-Martin A, Makatsariya A, Gris JC. Early ADAMTS13 testing associates with pre-eclampsia occurrence in antiphospholipid syndrome. Thromb Res. 2021 Jul;203:101-109. doi: 10.1016/j.thromres.2021.04.021. Epub 2021 Apr 27.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Pregnancy Complications; Hypertension, Pregnancy-Induced; Syndrome; Eclampsia; Pre-Eclampsia; Antiphospholipid Syndrome; Amino Acids, Peptides, and Proteins; Proteins; Carbohydrates; Hydrolases; Enzymes; Enzymes and Coenzymes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Glycoproteins; Glycoconjugates; Metalloendopeptidases; Peptide Hydrolases; Metalloproteases; Extracellular Matrix Proteins; Scleroproteins; ADAMTS Proteins; ADAM Proteins; Autoantibodies; ADAMTS13 Protein
• Other Study ID Numbers: Local/2020/JCG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No