The 3-Dimensional Ultrasound for Fetal Anomaly Scan

August 26, 2009 updated by: Sheba Medical Center

The 3-Dimensional Ultrasound for Fetal Anomaly Scan.

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.

Study Overview

Status

Unknown

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant woman

Description

Inclusion Criteria:

  • pregnant woman who come for fetal anomaly scan.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 27, 2009

Last Update Submitted That Met QC Criteria

August 26, 2009

Last Verified

August 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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