Comparative Evaluation of IRM and Autopsy in the Evaluati... | NCT02148055

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

NCT02148055

Sponsor

University Hospital, Rouen

Status

Terminated

Last Update Posted

Jun 15, 2017Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Spontaneous Intra Uterine Fetal Death

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitment

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

May 22, 2014

First Submission Date that Met QC Criteria

May 27, 2014

First Posted Date

May 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2017

Last Update Posted Date

Jun 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A group of 20 pregnant patients.	Other	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.	Other		A group of 20 pregnant patients.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Hopitaux de Rouen		Rouen		76000	France

Intervention Browse Module

MeSH Terms

ID	Term
D001344	Autopsy

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided