Antiphospholipid Antibody Syndrome in PregnancyNOH-ADAMTSNCT04319341
Obstetric Antiphospholipid Antibody Syndrome : Contribution of the Evaluation of ADAMTS13 Made at the Diagnosis of Pregnancy on Evaluation the Risk of Pre-eclampsia
An observational study of Antiphospholipid Antibody Syndrome in Pregnancy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Antiphospholipid Antibody Syndrome in Pregnancy
- What is being tested?
- To study the prognostic value on the occurrence of pre-eclampsia, ADAMTS13 (ADAMTS13 protein and autoantibodies) in patients diagnosed with oAPS
- How many people
- 513 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Absence of frozen plasma sample from the blood sample from the positive pregnancy test.
- Patient who objected to the use of their data.
Trial locations and contacts
1 site in 1 country.
About this study
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, ...
- Being tested
- To study the prognostic value on the occurrence of pre-eclampsia, ADAMTS13 (ADAMTS13 protein and autoantibodies) in patients diagnosed with oAPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To study the prognostic value on the occurrence of pre-eclampsia, ADAMTS13 (ADAMTS13 protein and autoantibodies) in patients diagnosed with oAPSOther
ADAMTS13 activity, ADAMS13 antigen and anti-ADAMTS13 autoantibodies: U/ml.
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantification, in vitro, of the activity of ADAMTS13
ADAMTS13 function, U/ml.
Measured: at inclusion (J0)
The quantification, in vitro, of ADAMTS13 antigen
ADAMTS13 antigen, U/ml.
Measured: at inclusion (J0)
The quantification, in vitro, of ADAMTS13 autoantibodies
ADAMTS13 autoantibodies, U/ml.
Measured: at inclusion (J0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid Antibody Syndrome in PregnancyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319341
- Sponsor's protocol ID
- Local/2020/JCG-01
- Acronym
- NOH-ADAMTS
- Status last verified
- Jan 2021
- First submitted
- 19 Mar 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33989981
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04319341
- Acronym / sponsor ID
- NOH-ADAMTS / Local/2020/JCG-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Absence of frozen plasma sample from the blood sample from the positive pregnancy test.
- Patient who objected to the use of their data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To study the prognostic value on the occurrence of pre-eclampsia, ADAMTS13 (ADAMTS13 protein and autoantibodies) in patients diagnosed with oAPSADAMTS13 activity, ADAMS13 antigen and anti-ADAMTS13 autoantibodies: U/ml. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 33989981Bitsadze 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Antibody Syndrome in Pregnancy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quantification, in vitro, of the activity of ADAMTS13 (time frame: at inclusion (J0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.