Homozygous αº-thalassemiaNCT00826917
Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies
An observational study of Homozygous αº-thalassemia and Hb Bart's Disease, run by The University of Hong Kong at 1 site in China.
Trial summary
Volumetry measurements can be a potential clinical use as non-invasive tools in prenatal diagnosis and screening and helps to reduce the risk and complications of invasive procedures. 3DUS volumetry gives more precise results than 2DUS volumetry measurements, particularly, of irregularly shaped objects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Homozygous αº-thalassemia, Hb Bart's Disease
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 1. Use of XI VOCALTM in 3D fetal volumetry measurements,comparison with multiplanar and VOCALTM -restropective(2005-2007),30 singleton pregnancies,11-14 weeks' gestation, at risk of homozygous αº-thalassaemia. 2. Use of XI VOCALTM in 3D placental volumetry measurements,comparison with multiplanar and VOCALTM -retrospective(2005-2007), 32 singleton pregnancies,11-14 weeks' gestation at risk of homologous alphaº thalassaemia. 3. Comparison of 3DUS volumetry measurement between two models of ultrasound machine -prospective(December 2007-June 2008),30 singleton normal pregnancies,11-14 weeks' gestation. 4. Use of 3DUS in fetal, gestational sac and placenta quotient measurement, fetuses at risk of homozygous αº-thalassemia(Hb Bart's disease) -retrospective(datasets July 2007-Dec 2008),singleton pregnancies,11-14 weeks' gestation,26 affected cases,34 unaffected cases,43 normal control.
Who may be able to join
- For objective 1 and 2 - Samples are recruited from our prenatal diagnostic clinic at Ysan Yuk Hospital between 11-14 weeks' gestation. They are those who come for routine scan and those who are referred from the general antenatal clinics of the same hospital which pregnancies are at risk of homologous alphaº thalassaemia.
- 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.
Who cannot join
- If women refuse to participate in the study
- Patients with other co-existing illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies - The Use of Volumetry by Three Dimensional Ultrasound in the First Trimester
Volumetry measurements can be a potential clinical use as non-invasive tools in prenatal diagnosis and screening and helps to reduce the risk and complications of invasive procedures. 3DUS volumetry gives more precise results than 2DUS volumetry measurements, particularly, of irregularly shaped objects.
Read the detailed description
Conventionally volume measurements can be made by using multiplanar or VOCALTM (Virtual Organ Computer-aided AnaLysis). Recently, a new technique, XI VOCALTM (eXtended Imaging VOCAL) has been described. Combined with the inversion mode, measurements for the liquid-filled structures can also be made. The potential use in clinical diagnosis and prediction of pathologies of volume measurements particularly in the first trimester are yet to be investigated.
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
- Homozygous αº-thalassemia, Hb Bart's Disease
- Keywords
- 3D, 2D, ultrasound, volumetry, multiplanar, VOCALTM, XI VOCALTM, fetal, gestational sac, placenta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Objective 1: XI VOCALTM in 3D fetal volumetry measurement | group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM | |
| Objective 2: XI VOCALTM in 3D placental volumetry measurement | group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM | |
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective 1:The use of XI VOCALTM in 3D volumetry measurements of fetal head and trunk of fetuses from 11 to 14 weeks gestation and known volume phantoms and its comparison with the conventional multiplanar and VOCALTM technique
The objectives of this study are to compare (1) the reproducibility of multiplanar and the VOCALTM technique for 3DUS measurement of fetal volume with the new modality XI VOCALTM, and (2) validity of these three techniques using an in-vitro setting.
The hypothesis of the study are (1) the results obtained from the new modality of XI VOCALTM is interchangeable with multiplanar and VOCALTM with similar number of steps used and (2) validity between XI VOCALTM is comparable to multiplanar and VOCALTM with similar number of steps used.
We hypothesized XI VOCALTM can be used interchangeably with multiplanar and VOCALTM technique if similar number of steps are used in the measurement of regular objects such as fetal head and trunk.
Measured: 18 months
Objective 2:The use of new modality of XI VOCALTM in 3D volumetry measurements of placenta from 11 to 14 weeks gestation and known volume phantoms and its comparison with the conventional multiplanar and VOCALTM technique
The objectives of this study are to compare (1) the reproducibility of multiplanar and the VOCALTM technique for 3DUS measurement of placenta volume with the new modality XI VOCALTM, and (2) validity of these three techniques using an in-vitro setting.
The hypothesis of the study are (1) the results obtained from the new modality of XI VOCALTM is interchangeable with multiplanar and VOCALTM with similar number of steps used and (2) validity between XI VOCALTM is comparable to multiplanar and VOCALTM with similar number of steps used.
We hypothesized that XI VOCALTM can be used interchangeably with the other two techniques for the volumetry measurement of irregular objects such as placenta if similar number of steps is used.
Measured: 18 months
Objective 3:The use of 3DUS in the volumetry of first trimester pregnancy and in vitro study: comparison between two models of ultrasound machine
The objective of the present study are to compare (1) the reproducibility of these two machines for fetal, gestational sac and placenta 3D volumetry using multiplanar (1-mm interval) and Virtual Organ Computer-Aided Analysis (VOCAL)TM (30º) technique and (2) validity of these two machines using an in-vitro setting.
Hypothesis of the study: 3D volumetry measurement of fetal, gestational sac and placenta volume of fetuses at 11 to 14 weeks' gestation with Voluson 730 is interchangeable with the measurement using Accuvix ultrasound machine.
We hypothesized that the Accuvix machine could be used interchangeably with Voluson 730 for both multiplanar and VOCALTM for fetal, gestational sac and placenta volumetry measurement.
Measured: 18 months
Objective 4:The use of 3DUS in the measurement of fetal, gestational sac and placenta quotient of fetuses at risk of homozygous αº-thalassemia (Hb Bart's disease) at 11 to 14 weeks' gestation
This study was carried out to evaluate the use of fetal, gestational sac and placenta volume measured by three-dimensional (3D) ultrasound in predicting fetal homozygous αº-thalassemia (Hb-Bart's disease).
Hypothesis of the study: Measurement of 3D volume of the fetal, gestational sac and placenta quotient can be used as a useful tool as 2D parameter for the prediction of fetuses of homozygous alpha0-thalassaemia (Hb Bart's disease) at 11 to 14 weeks' gestation.
We hypothesized that 3D volumetry measurement of the fetal, gestational sac and placenta quotient can serve as a useful tool as 2D parameter for the prediction of homozygous alpha0-thalassaemia (Hb Bart's disease) fetuses at 11 to 14 weeks' gestation.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Homozygous αº-thalassemiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kah Bik Cheong, BSc(Hons), MMedSc, MBBS, Principal investigator, The University of Hong KongKwok Yin Leung, MBBS, FHKAM, Study director, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826917
- Sponsor's protocol ID
- UW07-293
- Status last verified
- May 2015
- First submitted
- 21 Jan 2009
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20047196KY Leung, KB Cheong, MHY Tang. 2D and 3D Ultrasound Prediction of Homozygous αº-thalassemia. Donald School Journal of Ultrasound in Obstetrics and Gynecology, April-June 2010;4(2):123-126.
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.
PubMed 20201116Cheong 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.
PubMed 19248036Cheong 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).
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies - The Use of Volumetry by Three Dimensional Ultrasound in the First Trimester
- ClinicalTrials.gov ID
- NCT00826917
- Acronym / sponsor ID
- UW07-293
- Conditions
- Homozygous αº-thalassemia, Hb Bart's Disease
- Keywords
- 3D, 2D, ultrasound, volumetry, multiplanar, VOCALTM, XI VOCALTM, fetal, gestational sac, placenta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Volumetry measurements can be a potential clinical use as non-invasive tools in prenatal diagnosis and screening and helps to reduce the risk and complications of invasive procedures. 3DUS volumetry gives more precise results than 2DUS volumetry measurements, particularly, of irregularly shaped objects.
Detailed description
Conventionally volume measurements can be made by using multiplanar or VOCALTM (Virtual Organ Computer-aided AnaLysis). Recently, a new technique, XI VOCALTM (eXtended Imaging VOCAL) has been described. Combined with the inversion mode, measurements for the liquid-filled structures can also be made. The potential use in clinical diagnosis and prediction of pathologies of volume measurements particularly in the first trimester are yet to be investigated.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Objective 1: XI VOCALTM in 3D fetal volumetry measurement | – | –group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM |
| Objective 2: XI VOCALTM in 3D placental volumetry measurement | – | –group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM |
| 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 |
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Use of XI VOCALTM in 3D fetal volumetry measurements,comparison with multiplanar and VOCALTM -restropective(2005-2007),30 singleton pregnancies,11-14 weeks' gestation, at risk of homozygous αº-thalassaemia. 2. Use of XI VOCALTM in 3D placental volumetry measurements,comparison with multiplanar and VOCALTM -retrospective(2005-2007), 32 singleton pregnancies,11-14 weeks' gestation at risk of homologous alphaº thalassaemia. 3. Comparison of 3DUS volumetry measurement between two models of ultrasound machine -prospective(December 2007-June 2008),30 singleton normal pregnancies,11-14 weeks' gestation. 4. Use of 3DUS in fetal, gestational sac and placenta quotient measurement, fetuses at risk of homozygous αº-thalassemia(Hb Bart's disease) -retrospective(datasets July 2007-Dec 2008),singleton pregnancies,11-14 weeks' gestation,26 affected cases,34 unaffected cases,43 normal control.
Key inclusion criteria (3 listed)
- For objective 1 and 2 - Samples are recruited from our prenatal diagnostic clinic at Ysan Yuk Hospital between 11-14 weeks' gestation. They are those who come for routine scan and those who are referred from the general antenatal clinics of the same hospital which pregnancies are at risk of homologous alphaº thalassaemia.
- 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.
Key exclusion criteria (2 listed)
- If women refuse to participate in the study
- Patients with other co-existing illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective 1:The use of XI VOCALTM in 3D volumetry measurements of fetal head and trunk of fetuses from 11 to 14 weeks gestation and known volume phantoms and its comparison with the conventional multiplanar and VOCALTM technique
Time frame: 18 months
The objectives of this study are to compare (1) the reproducibility of multiplanar and the VOCALTM technique for 3DUS measurement of fetal volume with the new modality XI VOCALTM, and (2) validity of these three techniques using an in-vitro setting. The hypothesis of the study are (1) the results obtained from the new modality of XI VOCALTM is interchangeable with multiplanar and VOCALTM with similar number of steps used and (2) validity between XI VOCALTM is comparable to multiplanar and VOCALTM with similar number of steps used. We hypothesized XI VOCALTM can be used interchangeably with multiplanar and VOCALTM technique if similar number of steps are used in the measurement of regular objects such as fetal head and trunk.
Objective 2:The use of new modality of XI VOCALTM in 3D volumetry measurements of placenta from 11 to 14 weeks gestation and known volume phantoms and its comparison with the conventional multiplanar and VOCALTM technique
Time frame: 18 months
The objectives of this study are to compare (1) the reproducibility of multiplanar and the VOCALTM technique for 3DUS measurement of placenta volume with the new modality XI VOCALTM, and (2) validity of these three techniques using an in-vitro setting. The hypothesis of the study are (1) the results obtained from the new modality of XI VOCALTM is interchangeable with multiplanar and VOCALTM with similar number of steps used and (2) validity between XI VOCALTM is comparable to multiplanar and VOCALTM with similar number of steps used. We hypothesized that XI VOCALTM can be used interchangeably with the other two techniques for the volumetry measurement of irregular objects such as placenta if similar number of steps is used.
Objective 3:The use of 3DUS in the volumetry of first trimester pregnancy and in vitro study: comparison between two models of ultrasound machine
Time frame: 18 months
The objective of the present study are to compare (1) the reproducibility of these two machines for fetal, gestational sac and placenta 3D volumetry using multiplanar (1-mm interval) and Virtual Organ Computer-Aided Analysis (VOCAL)TM (30º) technique and (2) validity of these two machines using an in-vitro setting. Hypothesis of the study: 3D volumetry measurement of fetal, gestational sac and placenta volume of fetuses at 11 to 14 weeks' gestation with Voluson 730 is interchangeable with the measurement using Accuvix ultrasound machine. We hypothesized that the Accuvix machine could be used interchangeably with Voluson 730 for both multiplanar and VOCALTM for fetal, gestational sac and placenta volumetry measurement.
Objective 4:The use of 3DUS in the measurement of fetal, gestational sac and placenta quotient of fetuses at risk of homozygous αº-thalassemia (Hb Bart's disease) at 11 to 14 weeks' gestation
Time frame: 18 months
This study was carried out to evaluate the use of fetal, gestational sac and placenta volume measured by three-dimensional (3D) ultrasound in predicting fetal homozygous αº-thalassemia (Hb-Bart's disease). Hypothesis of the study: Measurement of 3D volume of the fetal, gestational sac and placenta quotient can be used as a useful tool as 2D parameter for the prediction of fetuses of homozygous alpha0-thalassaemia (Hb Bart's disease) at 11 to 14 weeks' gestation. We hypothesized that 3D volumetry measurement of the fetal, gestational sac and placenta quotient can serve as a useful tool as 2D parameter for the prediction of homozygous alpha0-thalassaemia (Hb Bart's disease) fetuses at 11 to 14 weeks' gestation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- BackgroundLeung 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.
- BackgroundLeung KY, Cheong KB, Tang MHY, Chan V. Prenatal Diagnosis of Thalassaemia. JPOG. 2008. 34(1): 37-42.
- Background: PubMed 20047196Leung 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.
- BackgroundKY Leung, KB Cheong, MHY Tang. 2D and 3D Ultrasound Prediction of Homozygous αº-thalassemia. Donald School Journal of Ultrasound in Obstetrics and Gynecology, April-June 2010;4(2):123-126.
- Results publication: PubMed 20201116Cheong 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.
- Results publication: PubMed 19248036Cheong 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.
- Results publicationCheong 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.
- Results publicationCheong 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.
- Results publicationCheong 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.
- Results publicationCheong 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.
- Results publicationKB 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.
- Results publicationCheong 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).
- 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.Link provided by the sponsor.
- 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? UOGLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kah Bik Cheong, BSc(Hons), MMedSc, MBBS principal investigator
The University of Hong Kong
Kwok Yin Leung, MBBS, FHKAM study director
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Homozygous αº-thalassemia and Hb Bart's Disease, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective 1:The use of XI VOCALTM in 3D volumetry measurements of fetal head and trunk of fetuses from 11 to 14 weeks gestation and known volume phantoms and its comparison with the conventional multiplanar and VOCALTM technique (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826917, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.