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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02148055
Acronym
COMPER
Enrollment
2
Registered
2014-05-28
Start date
2014-05-31
Completion date
2016-12-31
Last updated
2017-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Intra Uterine Fetal Death

Keywords

spontaneous intrauterine death, fetal MRI, autopsy

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.

Interventions

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

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Recognition of anatomic cerebral structures evaluated by a common grid.Before H 24 for MR. Bedore day 5 for autopsy.

Secondary

MeasureTime frame
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.
Comparaison of quality criteria of both exams.Before H24 for MRI. Before day 5 for autopsy.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026