Completed

NCT Number: NCT04319341

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

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, ...

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Key information

Conditions

Antiphospholipid Antibody Syndrome in Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémea

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

ADAMTS13 activity, ADAMS13 antigen and anti-ADAMTS13 autoantibodies: U/ml.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: NOH-ADAMTS

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Mar 24, 2020
Registry last updated: Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.