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Trial registered on ANZCTR
Registration number
ACTRN12618001100280
Ethics application status
Approved
Date submitted
19/06/2018
Date registered
2/07/2018
Date last updated
11/05/2022
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
11/05/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Computed Tomography (CT) Autopsy Compared to Conventional Post-Mortem Examination in Pregnancy Losses.
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Scientific title
Fetal Virtual Autopsy: The Value of Dual Energy Multidetector Computed Tomography as an Adjunct to Conventional Investigations in Pregnancy Losses.
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Secondary ID [1]
295244
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pregnancy Loss
308411
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Condition category
Condition code
Reproductive Health and Childbirth
307401
307401
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Full body noncontrast dual energy multidetector CT scan. Scans will be performed at the Women's and CHildren's Hospital in SA. Each scan will take around 5 minutes.
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Intervention code [1]
301580
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Diagnosis / Prognosis
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Comparator / control treatment
Post mortem examination
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Control group
Active
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Outcomes
Primary outcome [1]
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Fetal abnormalities - skeletal dysplasias, anomalies of the major organs including the brain, lungs, heart, kidneys, liver, major vessels, adrenal glands, head and neck.
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Assessment method [1]
306373
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Timepoint [1]
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Scan performed ASAP after delivery, autopsy as soon as is practicable after the CT scan.
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Secondary outcome [1]
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Sensitivity and specificity of Dual Energy Multidetector Computed Tomography scan in determining the presence of fetal abnormalities, when compared to standard post mortem examination.
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Assessment method [1]
348280
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Timepoint [1]
348280
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Scan performed ASAP after delivery, autopsy as soon as is practicable after the CT scan.
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Eligibility
Key inclusion criteria
Pregnancy gestation of 14 weeks or more.
Death in utero or early neonatal period.
To undergo full autopsy.
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Minimum age
14
Weeks
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Consent not given for full autopsy.
Consent not given for research.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Sensitivity and specificity, CT vs autopsy
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
18/06/2018
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Date of last participant enrolment
Anticipated
1/06/2022
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Actual
1/03/2022
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Date of last data collection
Anticipated
1/06/2022
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Actual
1/03/2022
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW,NT,SA,VIC
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Recruitment hospital [1]
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Womens and Childrens Hospital - North Adelaide
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Recruitment postcode(s) [1]
23021
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5006 - North Adelaide
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Funding & Sponsors
Funding source category [1]
299835
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Hospital
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Name [1]
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Women's and Children's Hospital
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Address [1]
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Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
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Country [1]
299835
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Australia
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Primary sponsor type
Individual
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Name
Sarah Constantine
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Address
Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
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Country
Australia
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Secondary sponsor category [1]
299188
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None
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Name [1]
299188
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Nil
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Address [1]
299188
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Nil
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Country [1]
299188
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300712
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Women's and Children's Health Network Human Research Ethics Committee [EC00197]
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Ethics committee address [1]
300712
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Level 2 Samuel Way Building
72 King William Road
North Adelaide SA 5006
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Ethics committee country [1]
300712
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Australia
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Date submitted for ethics approval [1]
300712
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31/05/2017
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Approval date [1]
300712
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03/07/2017
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Ethics approval number [1]
300712
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REC2448/6/2020
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Summary
Brief summary
The loss of a pregnancy, whether spontaneous or induced for medical reasons, is a very traumatic event for the parents. In many cases, the reasons for a fetal abnormality or miscarriage are not clear, but can be very important for future pregnancies and patient counselling. Fetal autopsy is performed (with parental consent) as often as possible, but some parents cannot consider autopsy at a very stressful time in their lives, and others cannot consent for cultural or religious reasons. Some of these parents will allow an external examination and x-rays which provide only limited information.
The use of multi-detector computed tomography (MDCT) is well established in forensic science units around the world. To date, there has been very little research into the value of MDCT in fetal deaths. A recent article by O’Donoghue et al. used MDCT as an adjunct to autopsy in the investigation of 3rd trimester stillbirths, finding good correlation between measurements obtained in both settings, although only half their cases underwent formal autopsy.1
We aim to investigate the value of MDCT as part of the investigation into fetal abnormalities and pregnancy losses in the 2nd and 3rd trimesters, and early neonatal period. While we do not propose to replace conventional autopsy, we hope to show a good correlation between radiological and pathological findings, so that we can offer a non-invasive alternative to autopsy where the parents cannot consent to dissection.
1. O'Donoghue K, O'Regan KN, Sheridan CP, O'Connor OJ, Benson J, McWilliams S, Moore N, Murphy MJ, Chopra R, Higgins JR, Maher MM. Investigation of the role of computed tomography as an adjunct to autopsy in the evaluation of stillbirth. Eur J Radiol. 2011 Apr 29. [Epub ahead of print].
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Trial website
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Trial related presentations / publications
The value of dual-energy multidetector computed tomography as an adjunct to conventional investigations in pregnancy losses: Initial findings. Poster presented at the RANZCR ASM 2014. DOI: 10.1594/ranzcr2014/R-0172
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Public notes
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Attachments [1]
2779
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/AnzctrAttachments/375378-2014CSM_R-0172.pdf
(Publication)
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Attachments [2]
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/AnzctrAttachments/375378-Virtopsy Ethics 2017.pdf
(Ethics approval)
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Attachments [3]
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/AnzctrAttachments/375378-Post-mortem Request Form - May 2017.pdf
(Participant information/consent)
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Attachments [4]
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/AnzctrAttachments/375378-Document(2).pdf
(Protocol)
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Contacts
Principal investigator
Name
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Dr Sarah Constantine
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Address
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Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
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Country
84570
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Australia
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Phone
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+61 8 8161 7000
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Fax
84570
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Email
84570
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[email protected]
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Contact person for public queries
Name
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Dr Sarah Constantine
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Address
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Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
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Country
84571
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Australia
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Phone
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+61 8 8161 7000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
84572
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Dr Sarah Constantine
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Address
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Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
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Country
84572
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Australia
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Phone
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+61 8 8161 7000
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Fax
84572
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Email
84572
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Sensitive information - confidentiality.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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