Clinical trial NCT03877900: A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital
Official title: A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stillbirth and Fetal Death
Termination of Pregnancy
Neonatal Death
Keywords: post mortem Magnetic Resonance Imaging
stillbirth
fetal death
neonatal death
Minimally Invasive Autopsy
Tissue samplings
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 26
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * stillbirth and fetal deaths over 21 weeks of gestation
* termination of pregnancy over 21 weeks of gestation
* neonatal death

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of virtopsy made completely
timeFrame: month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besancon
Study officials:
affiliation: CHU Besançon
name: Marion AUBER LENOIR, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: D'Hondt A, Cassart M, De Maubeuge R, Soto Ares G, Rommens J, Avni EF. Postmortem fetal magnetic resonance imaging: where do we stand? Insights Imaging. 2018 Aug;9(4):591-598. doi: 10.1007/s13244-018-0627-0. Epub 2018 Jun 4.