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

Antiphospholipid Antibody Syndrome in Pregnancy Clinical Trial

— NOH-ADAMTS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319341
• Other study ID #: Local/2020/JCG-01
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, ...

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antiphospholipid Antibody Syndrome in Pregnancy
• Antiphospholipid Syndrome
• Eclampsia
• Pre-Eclampsia
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémea	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quantification, in vitro, of the activity of ADAMTS13	ADAMTS13 function, U/ml.	at inclusion (J0)
Primary	The quantification, in vitro, of ADAMTS13 antigen	ADAMTS13 antigen, U/ml.	at inclusion (J0)
Primary	The quantification, in vitro, of ADAMTS13 autoantibodies	ADAMTS13 autoantibodies, U/ml.	at inclusion (J0)