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NCT00966537 Clinical Trial

The 3-Dimensional Ultrasound for Fetal Anomaly Scan

Pregnancy Clinical Trial

Official title:
The 3-Dimensional Ultrasound for Fetal Anomaly Scan.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00966537
Other study ID # SHEBA-09-4936-LG-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received August 26, 2009
Last updated August 26, 2009
Start date May 2008

Study information
Verified date August 2009
Source Sheba Medical Center
Contact Liat Gindes, MD
Email gindesl@smile.net.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

The aim of this study is 1) to study the clinical application of 3D/4D ultrasound for fetal scanning during pregnancy; 2) ) to study the clinical application of 3D/4D ultrasound for pelvic scanning; 3) to demonstrate how to optimally display the different organs. 4) to correlate our findings with other diagnostic tools like MRI, CT; 5) to correlate our findings with clinical outcome.

Description:

A prospective studies of patients that coming to the ultrasound (US) unit in Sheba Medical Center from November 2007 for diagnostic US examination.

Patients will receive information of the study (printed and oral) and will ask to sign informed consent to act as a research subject and permission to use personal heath information for research.

Studies is performed using commercially available ultrasound equipment (Voluson 730 Expert, General Electric Healthcare, Kretztechnik, Zipf, Austria) with volumetric abdominal RAB 4-8 MHz and volumetric transvaginal RIC 5-9 MHz transducer probes.

During the examination of the patient pictures and 3D/4D volumes will acquired either by static 3D or 4D Volume or STIC (Spacio Temporal Image Corelation), Contrast Imaging in plane C (VCI-C) with and without Doppler (Color, Power and High Definition) and with B-flow. Image quality will be assessed in various modes. For optimizing the image volumes manipulations will be performed by positioning of the

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- pregnant woman who come for fetal anomaly scan.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat-gan,

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

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