Clinical Trials Directory

Trials / Terminated

TerminatedNCT02148055

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERComparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.

Timeline

Start date
2014-05-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2014-05-28
Last updated
2017-06-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02148055. Inclusion in this directory is not an endorsement.