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临床试验/NCT04387253
NCT04387253已完成不适用

Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause.

研究概览

简要总结

Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses.

Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies.

If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination.

The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Major patient
  • Patient with late spontaneous abortion (≥15 weeks of gestation)
  • Benefiting from a Social Security scheme
  • Patient who consented to participate in the study
  • Free subject, without tutorship, curatorship or subordination

排除标准

  • Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
  • Concurrent participation in another clinical research study.

结局指标

主要结局

Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause.

时间窗: 2 months

Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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