Spontaneous Intra Uterine Fetal Death Clinical Trial
— COMPEROfficial title:
Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death.
| Verified date | June 2017 |
| Source | University Hospital, Rouen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Hopitaux de Rouen | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recognition of anatomic cerebral structures evaluated by a common grid. | Before H 24 for MR. Bedore day 5 for autopsy. | ||
| Secondary | Recognition and mesurement of anatomic thoracic and abdominal structures by a common grid. | Before H24 for MR. Before day 5 for autopsy. | ||
| Secondary | Recognition and mesurement of the placenta and umbilical cord. | Before H24 for IRM. Before day 5 for autopsy. | ||
| Secondary | Comparaison of quality criteria of both exams. | Before H24 for MRI. Before day 5 for autopsy. |