search
Back to results

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

Primary Purpose

Spontaneous Intra Uterine Fetal Death

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spontaneous Intra Uterine Fetal Death focused on measuring spontaneous intrauterine death, fetal MRI, autopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • CHU Hopitaux de Rouen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A group of 20 pregnant patients.

Arm Description

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

Outcomes

Primary Outcome Measures

Recognition of anatomic cerebral structures evaluated by a common grid.

Secondary Outcome Measures

Recognition and mesurement of anatomic thoracic and abdominal structures by a common grid.
Recognition and mesurement of the placenta and umbilical cord.
Comparaison of quality criteria of both exams.

Full Information

First Posted
May 22, 2014
Last Updated
June 13, 2017
Sponsor
University Hospital, Rouen
search

1. Study Identification

Unique Protocol Identification Number
NCT02148055
Brief Title
Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death
Acronym
COMPER
Official Title
Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Intra Uterine Fetal Death
Keywords
spontaneous intrauterine death, fetal MRI, autopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A group of 20 pregnant patients.
Arm Type
Other
Arm Description
20 patients referred for intrauterine spontaneous fetal death explored by MRI and autopsy.
Intervention Type
Other
Intervention Name(s)
Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.
Primary Outcome Measure Information:
Title
Recognition of anatomic cerebral structures evaluated by a common grid.
Time Frame
Before H 24 for MR. Bedore day 5 for autopsy.
Secondary Outcome Measure Information:
Title
Recognition and mesurement of anatomic thoracic and abdominal structures by a common grid.
Time Frame
Before H24 for MR. Before day 5 for autopsy.
Title
Recognition and mesurement of the placenta and umbilical cord.
Time Frame
Before H24 for IRM. Before day 5 for autopsy.
Title
Comparaison of quality criteria of both exams.
Time Frame
Before H24 for MRI. Before day 5 for autopsy.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Hopitaux de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs