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Trial registered on ANZCTR
Registration number
ACTRN12609000122257
Ethics application status
Not yet submitted
Date submitted
5/12/2008
Date registered
19/02/2009
Date last updated
19/02/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
The successful assessment of fetal palate on routine 3D ultrasound examination of the fetal face in pregnant women
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Scientific title
To study the success of the examination of the fetal secondary palate on a routine antenatal 3D ultrasound volume of the fetal face and the application of the examination at various gestation in pregnant women
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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:
Three-dimensional ultrasound examination of fetal palate
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ultrasonography for diagnosis of fetal cleft palate
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fetal secondary palate
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antenatal ultrasound
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fetal palate
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fetal soft palate
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fetal hard palate
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fetal cleft palate
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fetal cleft lip or palate
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fetal cleft lip and palate
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pregnancy
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obstetrics
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fetal anomalies (fetal cleft plate)
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fetal diagnosis
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prenatal diagnosis
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antenatal diagnosis
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Condition category
Condition code
Oral and Gastrointestinal
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Normal oral and gastrointestinal development and function
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Observational
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Patient registry
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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
Any women who had an ultrasound examination requested on their fetuses at gestational age of 15-35 weeks in the period 1/1/2007 to 31/10/2007 were included. A routine 3D ultrasound volume of the fetal face was taken and reviewed by the authors. The 3D ultrasound volume was manipluated to reveal the fetal soft and hard palates in the oblique axial plane, the oblique sagittal plane and the targetted reverse face view. The visualization of the fetal soft and hard palate in these planes were compared at each gestational period.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
Not applicable - this is an observational study.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The routine 3D ultrasound volume of the fetal face would be examined and manipulated by the observers (sonologist and ultrasound reviewer), to reach the oblique axial plane, oblique sagittal plane and the targetted reverse face view. The visualization of the fetal soft and hard palate in these planes were noted and the results compared within the same gestational age.
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Assessment method [1]
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Timepoint [1]
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The ultrasound examination was taken at one point at a gestational age of 15-35 weeks' gestation, on request by the pregnant women's medical practitioners. A routine 3D ultrasound volume of the fetal face would be taken during the ultrasound examinations and reviewed by the obsevers (sonologist and ultrasound reviewer).
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Secondary outcome [1]
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Whether the fetal uvula could be visualized in the 3 examination planes on manipulation of the three-dimensional ultrasound volume of the fetal face was noted by the observers (sonologist and ultrasound reviewer).
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Assessment method [1]
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Timepoint [1]
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This is examined at one point on review of the 3D ultrasound volume of the fetal face, which was taken at an ultrasound examination requested by the pregnant womens' medical practitioner at a gestation between 15 and 35 weeks.
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Eligibility
Key inclusion criteria
fetus with normal palate confirmed at birth
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Minimum age
15
Weeks
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Maximum age
35
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
fetuses with abnormal palate at birth
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Reply from NEAC: Ethnics committee application or approval would not be processed since it was an retrospective observational study with minimal risk and it had been completed.
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Dr. Hong Soo Wong
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Address [1]
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Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr. hong Soo Wong
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Address
Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Department of Obstetrics and Gynaecology
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Address [1]
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School of Medicine and Health Sciences,
University of Otago, Wellington,
P.O. Box 7343 Wellington South
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Country [1]
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New Zealand
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Secondary sponsor category [2]
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Hospital
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Name [2]
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Women's Health Service
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Address [2]
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Capital and Coast District Health Board,
Wellington Hospital, Riddiford Street, Newtown, Wellington, 6242
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Country [2]
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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National Ethics Advisory Committee
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Ethics committee address [1]
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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01/08/2008
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Approval date [1]
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Ethics approval number [1]
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N/A - an application for Ethics approval was sent in August 2008; however it was advised that for retrospective observational studies with minimal risk, application for Ethics approval is not required.
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Summary
Brief summary
In the period of 1/1/2007 to 31/10/2007, a 3D ultrasound volume of the fetal face was taken as a routine at antenatal ultrasound examination. The 3D volume was reviewed retrospectively in those fetuses examined at 15-35 weeks gestation, and later confirmed to have normal palate at birth. The fetal secondary palate was examined in the oblique axial, the oblique sagittal and the reverse face views targeted at the uvula. The possibility of viewing the fetal hard and soft palate at various gestations in these planes was analyzed and it was concluded that the fetal secondary palate (hard and soft palate) could be viewed from 15 weeks and onwards but consistently in all three views at or above 19 weeks gestation.
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Trial website
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Trial related presentations / publications
Wong HS, Tait J, Pringle KC. Viewing of the soft and hard palate on routine 3-D ultrasound sweep of the fetal face - a feasibility study. Fetal Diag Ther 2008;24(2):146-54. Wong HS, Tait J, Pringle KC. The examination of the fetal soft palate at various gestations on 3D ultrasound. Ultrasound Obstet Gynecol 2008;32(3):444. Wong HS, Tait J, Pringle KC. The fetal soft palate: not a nowhereland on 3D ultrasound. Ultrasound Obstet Gynecol 2007;30(4):484. Wong HS, Tait J, Pringle KC. An evaluation of the assessment methods for fetal cleft lip/palate on 3D ultrasound. Ultrasound Obstet Gynecol 2007;30(4):603.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr. Hong Soo Wong
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Address
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Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
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Country
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Australia
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Phone
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+61 7 3168 3005
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Fax
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+61 7 3324 2729
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr. Hong Soo Wong
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Address
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Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
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Country
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Australia
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Phone
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+61 7 3168 3005
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Fax
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+61 7 3324 2729
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Email
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[email protected]
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No information has been provided regarding IPD availability
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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