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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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Three-dimensional ultrasound examination of fetal palate 4076 0
ultrasonography for diagnosis of fetal cleft palate 4077 0
fetal secondary palate 4078 0
antenatal ultrasound 4079 0
fetal palate 4080 0
fetal soft palate 4081 0
fetal hard palate 4082 0
fetal cleft palate 4083 0
fetal cleft lip or palate 4084 0
fetal cleft lip and palate 4085 0
pregnancy 4086 0
obstetrics 4087 0
fetal anomalies (fetal cleft plate) 4088 0
fetal diagnosis 4089 0
prenatal diagnosis 4090 0
antenatal diagnosis 4091 0
Condition category
Condition code
Oral and Gastrointestinal 4284 4284 0 0
Normal oral and gastrointestinal development and function
Human Genetics and Inherited Disorders 4285 4285 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 4286 4286 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 3799 0
Not applicable
Comparator / control treatment
Not applicable - this is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5171 0
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.
Timepoint [1] 5171 0
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).
Secondary outcome [1] 8704 0
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).
Timepoint [1] 8704 0
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.

Eligibility
Key inclusion criteria
fetus with normal palate confirmed at birth
Minimum age
15 Weeks
Maximum age
35 Weeks
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
fetuses with abnormal palate at birth

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1461 0
New Zealand
State/province [1] 1461 0
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.

Funding & Sponsors
Funding source category [1] 4255 0
Self funded/Unfunded
Name [1] 4255 0
Dr. Hong Soo Wong
Address [1] 4255 0
Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
Country [1] 4255 0
Australia
Primary sponsor type
Individual
Name
Dr. hong Soo Wong
Address
Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
Country
Australia
Secondary sponsor category [1] 3828 0
University
Name [1] 3828 0
Department of Obstetrics and Gynaecology
Address [1] 3828 0
School of Medicine and Health Sciences,
University of Otago, Wellington,
P.O. Box 7343 Wellington South
Country [1] 3828 0
New Zealand
Secondary sponsor category [2] 3829 0
Hospital
Name [2] 3829 0
Women's Health Service
Address [2] 3829 0
Capital and Coast District Health Board,
Wellington Hospital, Riddiford Street, Newtown, Wellington, 6242
Country [2] 3829 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6306 0
National Ethics Advisory Committee
Ethics committee address [1] 6306 0
Ethics committee country [1] 6306 0
New Zealand
Date submitted for ethics approval [1] 6306 0
01/08/2008
Approval date [1] 6306 0
Ethics approval number [1] 6306 0
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.

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 29204 0
Address 29204 0
Country 29204 0
Phone 29204 0
Fax 29204 0
Email 29204 0
Contact person for public queries
Name 12361 0
Dr. Hong Soo Wong
Address 12361 0
Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
Country 12361 0
Australia
Phone 12361 0
+61 7 3168 3005
Fax 12361 0
+61 7 3324 2729
Email 12361 0
hsoowong@netvigator.com
Contact person for scientific queries
Name 3289 0
Dr. Hong Soo Wong
Address 3289 0
Australian Women's Ultrasound Centre,
P.O. Box 8223 Sunnybank,
Queensland 4109
Country 3289 0
Australia
Phone 3289 0
+61 7 3168 3005
Fax 3289 0
+61 7 3324 2729
Email 3289 0
hsoowong@netvigator.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary