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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
Sponsor:
Information provided by (Responsible Party):
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, ...


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

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Study Type : Observational
Estimated Enrollment : 513 participants
Observational Model: Cohort
Time Perspective: Retrospective
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



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. The quantification, in vitro, of the activity of ADAMTS13 [ Time Frame: at inclusion (J0) ]
    ADAMTS13 function, U/ml.

  2. The quantification, in vitro, of ADAMTS13 antigen [ Time Frame: at inclusion (J0) ]
    ADAMTS13 antigen, U/ml.

  3. The quantification, in vitro, of ADAMTS13 autoantibodies [ Time Frame: at inclusion (J0) ]
    ADAMTS13 autoantibodies, U/ml.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jean-Christophe GRIS 04.66.68.32.11 Jean.christophe.gris@chu-nimes.fr

Locations
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France
CHU de Nîmes - Hôpital Universitaire Carémea
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04319341    
Other Study ID Numbers: Local/2020/JCG-01
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Antiphospholipid Syndrome
Syndrome
Disease
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Autoimmune Diseases
Immune System Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs