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

University Hospital, Rouen

Status: Terminated

Conditions: Spontaneous Intra Uterine Fetal Death

Treatments: Other: Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.

Study type: Interventional

Funder types: Other

Identifiers

NCT02148055

2012/169/HP

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

A group of 20 pregnant patients.

Other group

Description:

20 patients referred for intrauterine spontaneous fetal death explored by MRI and autopsy.

Treatment:

Other: Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.