Hb Bart's Disease Clinical Trial
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
| Verified date | May 2015 |
| Source | The University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Hong Kong: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 195 |
| Est. completion date | August 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: 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 aº-thalassemia while for the control group, data is collected from normal pregnancies. Exclusion Criteria: - If women refuse to participate in the study - Patients with other co-existing illnesses |
Observational Model: Case Control
| Country | Name | City | State |
|---|---|---|---|
| China | Tsan Yuk Hospital | Hong Kong | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Hong Kong |
China,
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).
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 Gyneco
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
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 o
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. — View Citation
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
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 s — View Citation
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 Obstetr
KY Leung, KB Cheong, MHY Tang. 2D and 3D Ultrasound Prediction of Homozygous aº-thalassemia. Donald School Journal of Ultrasound in Obstetrics and Gynecology, April-June 2010;4(2):123-126.
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. — View Citation
Leung KY, Cheong KB, Lee CP, Chan V, Tang MHY, Lau ETK. Prenatal diagnosis of homozygous a°-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.
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
18 months | Yes |
| Primary | 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. |
18 months | Yes |
| Primary | 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. |
18 months | Yes |
| Primary | Objective 4:The use of 3DUS in the measurement of fetal, gestational sac and placenta quotient of fetuses at risk of homozygous aº-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 aº-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. |
18 months | Yes |