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临床试验/NCT04319341
NCT04319341已完成不适用

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

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 513 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
513
试验地点
1
主要终点
The quantification, in vitro, of the activity of ADAMTS13

研究概览

简要总结

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, ...

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Absence of frozen plasma sample from the blood sample from the positive pregnancy test.
  • Patient who objected to the use of their data.

结局指标

主要结局

The quantification, in vitro, of the activity of ADAMTS13

时间窗: at inclusion (J0)

ADAMTS13 function, U/ml.

The quantification, in vitro, of ADAMTS13 antigen

时间窗: at inclusion (J0)

ADAMTS13 antigen, U/ml.

The quantification, in vitro, of ADAMTS13 autoantibodies

时间窗: at inclusion (J0)

ADAMTS13 autoantibodies, U/ml.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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