跳至主要内容
临床试验/NCT02148055
NCT02148055终止不适用

Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death.

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2
试验地点
2
主要终点
Recognition of anatomic cerebral structures evaluated by a common grid.

研究概览

简要总结

Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and psychologically painful for the couple and the healthcare team. In this difficult context, it is essential to understand the etiology of death to guide the management of subsequent pregnancies. Among the investigations, foetopathologic examination is essential, but the examination of the brain is not possible in more than half of the cases due to the cerebral maceration due to the incompressible delay between death and expulsion.

The use of MRI as a diagnostic tool fetal post- mortem " virtual autopsy " performed before expulsion of the fetus is interesting because it would permit to obtain a macroscopic examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI abnormalities are found , it will not only guide the foetopathologic review, but mainly to guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the couple would be better than autopsy which is often refused by the couple in this difficult psychological context.

In this study , MRI will be given in addition to conventional autopsy in the painful waiting time between the time of diagnosis of death and expulsion without delaying care . If this study is validated , MRI may be systematically proposed in this indication or alternative to autopsy when it will be refused by the parents.

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
None

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

  • Patient for which he was diagnosed with intra uterine death confirmed by ultrasound
  • Mono fetal pregnancy,
  • Term: 24 to 42 weeks' gestation
  • Age> 18 years
  • Patient having readen the letter of information and signed the consent.

排除标准

  • Contraindication to MRI (heart valve, pacemaker, neurosurgical clips, claustrophobia, intraocular metallic foreign bodies)
  • Maternal complications: bleeding during, eclampsia, placental hematoma retro, imminent work
  • Twin pregnancy
  • Patient under guardianship or trusteeship
  • Patient not speaking and writing French

结局指标

主要结局

Recognition of anatomic cerebral structures evaluated by a common grid.

时间窗: Before H 24 for MR. Bedore day 5 for autopsy.

次要结局

  • Comparaison of quality criteria of both exams.(Before H24 for MRI. Before day 5 for autopsy.)
  • Recognition and mesurement of anatomic thoracic and abdominal structures by a common grid.(Before H24 for MR. Before day 5 for autopsy.)
  • Recognition and mesurement of the placenta and umbilical cord.(Before H24 for IRM. Before day 5 for autopsy.)

研究者

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

研究点 (2)

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