Trial Review

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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Computed Tomography (CT) Autopsy Compared to Conventional Post-Mortem Examination in Pregnancy Losses.
Scientific title
Fetal Virtual Autopsy: The Value of Dual Energy Multidetector Computed Tomography as an Adjunct to Conventional Investigations in Pregnancy Losses.
Secondary ID [1] 295244 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy Loss 308411 0
Condition category
Condition code
Reproductive Health and Childbirth 307401 307401 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 301580 0
Diagnosis / Prognosis
Comparator / control treatment
Post mortem examination
Control group
Active

Outcomes
Primary outcome [1] 306373 0
Fetal abnormalities - skeletal dysplasias, anomalies of the major organs including the brain, lungs, heart, kidneys, liver, major vessels, adrenal glands, head and neck.
Timepoint [1] 306373 0
Scan performed ASAP after delivery, autopsy as soon as is practicable after the CT scan.
Secondary outcome [1] 348280 0
Sensitivity and specificity of Dual Energy Multidetector Computed Tomography scan in determining the presence of fetal abnormalities, when compared to standard post mortem examination.
Timepoint [1] 348280 0
Scan performed ASAP after delivery, autopsy as soon as is practicable after the CT scan.

Eligibility
Key inclusion criteria
Pregnancy gestation of 14 weeks or more.
Death in utero or early neonatal period.
To undergo full autopsy.
Minimum age
14 Weeks
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consent not given for full autopsy.
Consent not given for research.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sensitivity and specificity, CT vs autopsy

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/06/2018
Date of last participant enrolment
Anticipated
1/06/2022
Actual
1/03/2022
Date of last data collection
Anticipated
1/06/2022
Actual
1/03/2022
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,NT,SA,VIC
Recruitment hospital [1] 11180 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 23021 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 299835 0
Hospital
Name [1] 299835 0
Women's and Children's Hospital
Country [1] 299835 0
Australia
Primary sponsor type
Individual
Name
Sarah Constantine
Address
Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 299188 0
None
Name [1] 299188 0
Nil
Address [1] 299188 0
Nil
Country [1] 299188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300712 0
Women's and Children's Health Network Human Research Ethics Committee [EC00197]
Ethics committee address [1] 300712 0
Level 2 Samuel Way Building
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 300712 0
Australia
Date submitted for ethics approval [1] 300712 0
31/05/2017
Approval date [1] 300712 0
03/07/2017
Ethics approval number [1] 300712 0
REC2448/6/2020

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].
Trial website
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
Public notes
Attachments [1] 2779 2779 0 0
/AnzctrAttachments/375378-2014CSM_R-0172.pdf (Publication)
Attachments [2] 2780 2780 0 0
/AnzctrAttachments/375378-Virtopsy Ethics 2017.pdf (Ethics approval)
Attachments [3] 2781 2781 0 0
/AnzctrAttachments/375378-Post-mortem Request Form - May 2017.pdf (Participant information/consent)
Attachments [4] 2782 2782 0 0
/AnzctrAttachments/375378-Document(2).pdf (Protocol)

Contacts
Principal investigator
Name 84570 0
Dr Sarah Constantine
Address 84570 0
Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 84570 0
Australia
Phone 84570 0
+61 8 8161 7000
Fax 84570 0
Email 84570 0
[email protected]
Contact person for public queries
Name 84571 0
Sarah Constantine
Address 84571 0
Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 84571 0
Australia
Phone 84571 0
+61 8 8161 7000
Fax 84571 0
Email 84571 0
[email protected]
Contact person for scientific queries
Name 84572 0
Sarah Constantine
Address 84572 0
Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 84572 0
Australia
Phone 84572 0
+61 8 8161 7000
Fax 84572 0
Email 84572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive information - confidentiality.


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.