ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy Loss

Condition category

Condition code

Reproductive Health and Childbirth

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]

Diagnosis / Prognosis

Comparator / control treatment

Post mortem examination

Control group

Active

Outcomes

Primary outcome [1]

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]

Scan performed ASAP after delivery, autopsy as soon as is practicable after the CT scan.

Secondary outcome [1]

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]

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?

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]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Women's and Children's Hospital

Address [1]

Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Country [1]

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]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee [EC00197]

Ethics committee address [1]

Level 2 Samuel Way Building
72 King William Road
North Adelaide SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/05/2017

Approval date [1]

03/07/2017

Ethics approval number [1]

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]

/AnzctrAttachments/375378-2014CSM_R-0172.pdf (Publication)

Attachments [2]

/AnzctrAttachments/375378-Virtopsy Ethics 2017.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/375378-Post-mortem Request Form - May 2017.pdf (Participant information/consent)

Attachments [4]

/AnzctrAttachments/375378-Document(2).pdf (Protocol)

Contacts

Principal investigator

Name

Dr Sarah Constantine

Address

Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7000

Fax

sarah.constantine@sa.gov.au

Contact person for public queries

Name

Sarah Constantine

Address

Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7000

Fax

sarah.constantine@sa.gov.au

Contact person for scientific queries

Name

Sarah Constantine

Address

Department of Medical Imaging
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7000

Fax

sarah.constantine@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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Documents added manually

Documents added automatically