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

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

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.

Study Overview

• Status: Terminated
• Conditions: Spontaneous Intra Uterine Fetal Death
• Intervention / Treatment: Other: Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • CHU Hôpitaux de Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A group of 20 pregnant patients.; 20 patients referred for intrauterine spontaneous fetal death explored by MRI and autopsy.	Other: Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recognition of anatomic cerebral structures evaluated by a common grid.	Before H 24 for MR. Bedore day 5 for autopsy.

Secondary Outcome Measures

Outcome Measure	Time 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.

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: autopsy; spontaneous intrauterine death; fetal MRI
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth
• Other Study ID Numbers: 2012/169/HP