Clinical Trial: Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: University Hospital, Rouen

Current Primary Outcome: Recognition of anatomic cerebral structures evaluated by a common grid. [ Time Frame: Before H 24 for MR. Bedore day 5 for autopsy. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: May 22, 2014
Date Started: May 2014
Date Completion: December 2016
Last Updated: June 15, 2016
Last Verified: June 2016