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

31. Mai 2015 aktualisiert von: The University of Hong Kong

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

195

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

China
- Hong Kong
  - Hong Kong, Hong Kong, China
    - Tsan Yuk Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.
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.
Comparison of 3DUS volumetry measurement between two models of ultrasound machine -prospective(December 2007-June 2008),30 singleton normal pregnancies,11-14 weeks' gestation.
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.

Beschreibung

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 αº-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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Beobachtungsmodelle: Fallkontrolle

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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 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 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
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 Zeitfenster: 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.	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 Zeitfenster: 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.	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 Zeitfenster: 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.	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 Zeitfenster: 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.	18 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The University of Hong Kong

Ermittler

Hauptermittler: Kah Bik Cheong, BSc(Hons), MMedSc, MBBS, The University of Hong Kong
Studienleiter: Kwok Yin Leung, MBBS, FHKAM, The University of Hong Kong

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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).

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2008

Primärer Abschluss (Tatsächlich)

1. Juni 2009

Studienabschluss (Tatsächlich)

1. August 2009

Studienanmeldedaten

Zuerst eingereicht

21. Januar 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Januar 2009

Zuerst gepostet (Schätzen)

22. Januar 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

2. Juni 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Mai 2015

Zuletzt verifiziert

1. Mai 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

3D, 2D, ultrasound, volumetry, multiplanar, VOCALTM, XI VOCALTM, fetal, gestational sac, placenta

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

UW07-293

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