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Completed

NCT Number: NCT03877900

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

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.

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Key information

Conditions

Stillbirth and Fetal Death Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Neonatal Death Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Stillbirth Termination of Pregnancy Urogenital Diseases

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Besancon

Besançon, 25030, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of virtopsy made completely

    Time frame: month 12

    Number of virtopsy made completely (from death until clinical report).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: VIRTOPSY+

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2019
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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