Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies

This study has been completed.

Sponsor:

Information provided by:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00826917

First received: January 21, 2009

Last updated: January 28, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 21, 2009
Last Updated Date	January 28, 2010
Start Date ^ICMJE	March 2008
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 21, 2009)	The diagnostic accuracy of fetal abnormalities [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00826917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 21, 2009)	The diagnostic accuracy of birth weight, maternal-fetal bonding and maternal anxiety (in both short and long term follow up). [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies
Official Title ^ICMJE	Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies
Brief Summary	The usage of 3D/4D in additional to 2DUS can improve the assessment of structural anomalies at early gestation (11 to 14 weeks gestation), improve in the prediction of birth weight, decrease maternal anxiety and increase maternal-fetal bonding compared to 2DUS, 3DUS can be used to measure fetal volume, gestational sac and placenta volume with different methods (multiplanar, VOCAL and XIVOCAL, to measure fetal, gestational sac and placenta volume for alpha(0)thalassaemia studies and comparison between 2 ultrasound machines (Accuvix and Voluson 730).
Detailed Description	This study is carried out to do: to determine if the use of 3D/4D ultrasound at 11-14 weeks gestation can increase the accuracy in the detection of fetal abnormalities, reduce maternal anxiety (in both short and long term), improve maternal-fetal bonding (in both short and long term) and improve the accuracy of the prediction of birth-weight over 2D ultrasound alone to determine if there is any difference in the measurement of fetal volume between two models of 3D ultrasound machines (Voluson 730 and Accuvix) to determine if there is any difference in the measurement of fetal volume among three methods (multiplanar, VOCAL, XIVOCAL) to determine if there is any difference in the measurement of placenta volume among three methods (multiplanar, VOCAL and XIVOCAL) Measurement of fetal, gestational sac and placenta volume for alpha(0)thalassaemia patients at 11-14 weeks of gestation
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	total 426 patients at 11-14 weeks of gestation control group 213 patients study group 213 patients
Condition ^ICMJE	Fetal Anomaly
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 group 1: control with 2DUS at 11-14 weeks gestation and follow up with 2DUS at 18-20 weeks gestation 2 study group with 2DUS + 3DUS at 11-14 weeks of gestation followed by 2DUS at 18-20 weeks of gestation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	426
Completion Date	August 2009
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women are recruited from our prenatal diagnostic clinic at Ysan Yuk Hospital before 14 weeks gestation. They are those who come for routine scan and those who are referred from the general antenatal clinics of the same hospital. Their pregnancies are at risk of fetal abnormalities because of advanced maternal age, a family or previous history of congenital abnormalities, an abnormal Down syndrome screening test, drug intake in early pregnancy or maternal disease Exclusion Criteria: If women refuse to participate in the study
Gender	Female
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT00826917
Other Study ID Numbers ^ICMJE	UW07-293
Has Data Monitoring Committee	Yes
Responsible Party	Dr Cheong Kah Bik, Department of Obstetric and Gynecology, The University of Hong Kong
Study Sponsor ^ICMJE	The University of Hong Kong
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	The University of Hong Kong
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top