跳至主要内容
临床试验/NCT05124574
NCT05124574终止不适用

Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
Spike SARS-COV-2 protein in placental tissues

研究概览

简要总结

SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .

The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

详细描述

In 2021, it becomes essential to clarify if and how SARS-COV-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of COVID-19.

SARS-COV-2, ACE2 and TMPRSS2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. From a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the Spike SARS-COV-2 protein, but also of the ACE2 receptors, TMPRSS2 and cathepsin L. Cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. Maternal leukocytes were also labeled for these proteins.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Social security affiliation
  • Signed informed consent
  • Pregnant woman with proven SARS-COV-2 infection during full-term delivery

排除标准

  • Patient vaccinated within 15 days prior to inclusion

结局指标

主要结局

Spike SARS-COV-2 protein in placental tissues

时间窗: Baseline : childbirth

number of cells expressing the Spike SARS-COV-2 protein

次要结局

  • TMPRSS2 in placental tissues(Baseline : childbirth)
  • cathepsin L in placental tissues(Baseline : childbirth)
  • ACE2 receptors in placental tissues(Baseline : childbirth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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