A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

Completed

• Conditions: Stillbirth and Fetal Death; Termination of Pregnancy; Neonatal Death

• Registration Number: NCT03877900
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

Detailed Description

Minimally invasive autopsy is an alternative for conventional autopsy including post mortem magnetic resonance (MR) imaging and tissues samplings.

Because of the raise of parental refusal of autopsy, we intend to assess the local feasibility of a minimally invasive autopsy approach using post mortem MR imaging of fetuses and newborns in order to detect the major pathological abnormalities and/or to determinate the cause of death.

Study Timeline

• Study Start: 2019-02-28
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• stillbirth and fetal deaths over 21 weeks of gestation
• termination of pregnancy over 21 weeks of gestation
• neonatal death
• patient having read the letter of information and signed the consent.

Exclusion Criteria

• legal incapacity
• limited ability to consent
• lack of parental consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of virtopsy made completely	month 12	Number of virtopsy made completely (from death until clinical report).

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besançon, France