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临床试验/NCT05188066
NCT05188066尚未招募不适用

Study of Pregnancy Pathologies Associated With Placental Abnormalities

University Hospital, Grenoble0 个研究点目标入组 800 人开始时间: 2022年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
800
主要终点
To better characterize pregnancy pathologies from implantation to childbirth

研究概览

简要总结

Pregnancy pathologies can occur from implantation until childbirth. The investigators are interested in the development mechanisms of these pathologies and aim to develop therapies to treat them.

The investigators need to collect samples, especially placental samples, following abortions and term and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for the understanding of the histological changes that occur in normal placentas collected at term of pregnancy. The latter will, in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of pre-eclampsia. This study will allow investigators to advance their understanding of the pathophysiological mechanisms of the placenta. The investigators are internationally recognized for their research on these pathologies.

详细描述

Pregnancy pathologies can occur from implantation until childbirth. Clinical and scientific investigators are interested in the study of the mechanisms of development of these pathologies and aim to develop therapies to treat them.

The investigators need to collect samples, especially placental samples, following abortions, term, and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for understanding the histological changes that occur in normal placentas collected at term of pregnancy. The latter, will in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of preeclampsia. This study will allow investigators to advance the understanding of the pathophysiological mechanisms of the placenta.

The investigators are internationally recognized for its research on these thematic.

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 52 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women
  • Admitted to the CHUGA for a birth or an abortion.
  • Pregnant women consenting to the collection of their fetal placenta membranes, during premature deliveries or at term of pregnancy OR Women performing an abortion consenting to the collection of their abortion products.
  • Having signed a consent
  • Affiliated with social security

排除标准

  • Placental sample or abortion product unavailable (not collected or necessary for treatment).
  • Patient with known positive HIV or Hepatitis B or Hepatitis C serology or at risk according to the infectious safety criteria applied by the EFS.
  • hemoglobin <7d / dL or hemoglobin <10g / dL if she suffers from a cardio-respiratory pathology).
  • Patient protected by law (minor, hospitalized under duress, subject to a legal protection measure by guardianship or curatorship, deprived of liberty by judicial or administrative decision)

结局指标

主要结局

To better characterize pregnancy pathologies from implantation to childbirth

时间窗: Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours

Comparison of the frequencies (in percentage) of the histological differences of the placenta and its appendages in patients with pathological and normal pregnancies (histological differences of normal pregnancies versus pathological pregnancies.

次要结局

  • Link between the frequencies of histological aberrations and worsening of the pathology(Assessement of the link between the frequencies of histological aberrations and worsening of the pathology will be assessed on the final cohort; This will take up to 3 hours for each aberration.)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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