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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
  Purpose

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).


Condition
Fetal Anomaly

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • The diagnostic accuracy of fetal abnormalities [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 426
Study Start Date: March 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

This study is carried out to do:

  1. 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
  2. to determine if there is any difference in the measurement of fetal volume between two models of 3D ultrasound machines (Voluson 730 and Accuvix)
  3. to determine if there is any difference in the measurement of fetal volume among three methods (multiplanar, VOCAL, XIVOCAL)
  4. to determine if there is any difference in the measurement of placenta volume among three methods (multiplanar, VOCAL and XIVOCAL)
  5. Measurement of fetal, gestational sac and placenta volume for alpha(0)thalassaemia patients at 11-14 weeks of gestation
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

total 426 patients at 11-14 weeks of gestation control group 213 patients study group 213 patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826917

Locations
China, Hong Kong
Tsan Yuk Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr Cheong Kah Bik, Department of Obstetric and Gynecology, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00826917     History of Changes
Other Study ID Numbers: UW07-293
Study First Received: January 21, 2009
Last Updated: January 28, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
3D, 2D, fetal anomalies

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013