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

NCT ID: NCT02148055

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Spontaneous Intra Uterine Fetal Death

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A group of 20 pregnant patients.

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

Group Type: OTHER

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

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Hopitaux de Rouen

Rouen, , France

Countries

France

Other Identifiers

2012/169/HP

Identifier Type: -

Identifier Source: org_study_id