Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies
NCT ID: NCT00826917
Last Updated: 2015-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
195 participants
OBSERVATIONAL
2008-03-31
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia
NCT04422067
Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of Central Nervous System (CNS) Pathology
NCT00687752
MRI Versus Four Dimensional Ultrasound in Detection of CNS Fetal Congenital Anomalies
NCT03888794
Study of Fetal Swallowing
NCT00004566
Effect of Head Rotation on Overlap and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children: A Study of the Anatomy Using Ultrasonography
NCT01017328
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
3D ultrasound is found to be superior to 2D parameter in volumetry measurement. However, currently, there are still very few studies done to evaluate the potential use of volumetry measurement in clinical practice, especially of the validity and reproducibility of XI VOCALTM; and the variation of results obtained within different ultrasound machines. Due to the potential use of volumetry measurements in clinical practice, the accuracy in volumetry measurement is very important and the development of new technique need to be fully explored so that its benefits can be fully used for the contribution of clinical practice.
So far no research has been done to evaluate the difference in the results obtained between different ultrasound machines, in particularly for volumetry measurements. This is important because if there is no significant difference in results between difference machines, we can accumulate the results from these machines for a study, which can include a more variety of samples. Furthermore, it will be much easier to compare results of one machine with another for similar studies.
Both Voluson 730 and Accuvix have been used widely in research studies on 3D volumetry but comparison of the results obtained from these two machines have not been done. We do not know whether the results generated from one machine can be extrapolated to the other machine for clinical or research purpose. Thus more research needs to be done in this area.
Thus, this study is carried out to evaluate the potential use of the new modality of XI VOCALTM in the volumetry measurement of regular and irregular shaped objects, comparison of results obtained between different widely used machines, and the potential used of volumetry measurements in the prediction of common and important clinical pathologies such as αº-thalassemia.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Objective 1: XI VOCALTM in 3D fetal volumetry measurement
group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM
No interventions assigned to this group
Objective 2: XI VOCALTM in 3D placental volumetry measurement
group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM
No interventions assigned to this group
Objective 3: Comparison between 2 ultrasound machine
1. intramachine reliability for (i)fetal, (ii)gestational sac and (iii)placenta volumetry measurement for (a)multiplanar and (b)VOCALTM:- group 1:Accuvix; group 2:Voluson 730
2. intermachine reliability for fetal, gestational sac and placenta volumetry measurement for (a)multiplanar and (b)VOCALTM for Accuvix and Voluson 730
No interventions assigned to this group
Objective 4:3D volumetry in fetuses at risk of Hb Bart's
Measurement of fetal, gestational sac and placenta volume per CRL quotient using multiplanar technique:- group 1: affected; group 2: unaffected
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
For objective 3 - Recruitment are the same as above except samples are obtained from normal pregnancy.
For objective 4 - Recruitment are the same as above. However, study is divided into intervention group and control group. For the intervention group, data is collected from pregnancies at risk of of homozygous αº-thalassemia while for the control group, data is collected from normal pregnancies.
Exclusion Criteria
* Patients with other co-existing illnesses
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kah Bik Cheong, BSc(Hons), MMedSc, MBBS
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Kwok Yin Leung, MBBS, FHKAM
Role: STUDY_DIRECTOR
The University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tsan Yuk Hospital
Hong Kong, Hong Kong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Leung KY, Cheong KB, Lee CP, Chan V, Tang MHY, Lau ETK. Prenatal diagnosis of homozygous α°-thalassemia: from an invasive to a noninvasive approach. Expert Reviews. 2009.4(3): 321-329.
Leung KY, Cheong KB, Tang MHY, Chan V. Prenatal Diagnosis of Thalassaemia. JPOG. 2008. 34(1): 37-42.
Leung KY, Cheong KB, Lee CP, Chan V, Lam YH, Tang M. Ultrasonographic prediction of homozygous alpha0-thalassemia using placental thickness, fetal cardiothoracic ratio and middle cerebral artery Doppler: alone or in combination? Ultrasound Obstet Gynecol. 2010 Feb;35(2):149-54. doi: 10.1002/uog.7443.
Cheong KB, Leung KY, Li TK, Chan HY, Lee YP, Tang MH. Comparison of inter- and intraobserver agreement and reliability between three different types of placental volume measurement technique (XI VOCAL, VOCAL and multiplanar) and validity in the in-vitro setting. Ultrasound Obstet Gynecol. 2010 Aug;36(2):210-7. doi: 10.1002/uog.7609.
Cheong KB, Leung KY, Chan HY, Lee YP, Yang F, Tang MH. Comparison of inter- and intraobserver agreement between three types of fetal volume measurement technique (XI VOCAL, VOCAL and multiplanar). Ultrasound Obstet Gynecol. 2009 Mar;33(3):287-94. doi: 10.1002/uog.6255.
Cheong KB, Leung KY, Chan HY, Chen M, Tang MHY. Comparison of volumetry fetus, gestational sac, and placenta obtained from two three- dimensional ultrasound machines. 18th World Congress on Ultrasound in Obstetrics and Gynecology. Ultrasound Obstet Gynecol. 2008; 32: 400.
Cheong KB, Leung KY, Chan HY, Chen M, Tang MHY. Comparison of volumetry of fetus, gestational sac, and placenta in normal pregnancies obtained by two kinds of three dimensional ultrasound machines. 4th Asia Pacific Congress inMaternal Fetal Medicine. 17Th - 19th October, 2009. Macau Tower Convention and Entertainment Center, Macau, SAR China.
Cheong KB, Leung KY, Li TK, Chan HY, Lee YP, Tang HY. Comparison of inter- and intraobserver agreement between three different types of placental volume measurement techniques (XI VOCALTM, VOCALTM and multiplanar). 13rd -17th Sept 2009. Ultrasound Obstet Gynecol. 2009. 34 (Suppl 1): 209.
Cheong KB, Leung KY, Chan HY, Lee YP, Tang MHY. Comparison of inter- and intraobserver agreement between three different types of fetal volume measurement techniques (XI VOCALTM, VOCALTM and multiplanar). 13th Postgraduate Symposium, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, SAR China. 2008.
KB Cheong, KY Leung, HY Chan, YP Lee, F Yang, MHY Tang. Comparison of inter- and intra-observer agreement between three different types of fetal volume measurement techniques (XI VOCAL, VOCAL, and multiplanar). 18th World Congress on Ultrasound in Obstetrics and Gynecology. Ultrasound Obstet Gynecol. 2008; 32(3):399.
Cheong Kah-bik, Ng EHY.The use of volumetry by three-dimensional ultrasound in the first trimester. 2009. Postgraduate Thesis. The HKU Scholars Hub (thesis online).
Related Links
Access external resources that provide additional context or updates about the study.
KB Cheong, KY Leung, HY Chan, M Chen, MHY Tang. P25.07: Comparison of volumetry of fetus, gestational sac, and placenta obtained from two three-dimensional ultrasound machines. Ultrasound in Obstetrics \& Gynecology. 18th World Congress on UOG.
Cheong KB, Leung KY, Chan HY, Lee YP, Yang F, Tang MHY. P25.06 Comparison of inter- and intra-observer agreement between three different types of fetal volume measurement techniques (XI VOCALTM, VOCALTM and multiplanar). 18th World Congress on UOG
KB Cheong, KY Leung, TK Li, HY Chan, YP Lee, HY Tang. P09.01 Comparison of inter- and intraobserver agreement between three different types of placental volume measurement techniques (XI VOCALTM, VOCALTM, and multiplanar). UOG. 2009; 34(Suppl 1): 209.
KB Cheong, KY Leung, HY Chan, YP Lee, F Yang, MHY Tang. Comparison of inter- and intraobserver agreement between three types of fetal volume measurement technique (XI VOCALTM, VOCALTM and multiplanar). Ultrasound Obstet Gynecol 2009; 33: 287-294
Leung KY, Cheong KB, Lee CP, Chan V, Lam YH, Tang M. Ultrasonographic prediction of homozygous alphaº-thalassemia using placental thickness, fetal cardiothoracic ratio and middle cerebral artery Doppler: alone or in combination? UOG
KB Cheong,KY Leung,TKT Li,HY Chan,YP Lee,MHY Tang.Comparison of inter-and intraobserver agreement and reliability between three different types of placental volume measurement technique(XIVOCALTM, VOCALTM and multiplanar)
Cheong Kah-bik, Ng EHY.The use of volumetry by three-dimensional ultrasound in the first trimester. 2009. Postgraduate thesis. The HKU Scholars Hub (thesis online).
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UW07-293
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.