PregnancyNCT00966537
The 3-Dimensional Ultrasound for Fetal Anomaly Scan
An observational study of Pregnancy, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to not given
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant woman
Who may be able to join
- pregnant woman who come for fetal anomaly scan.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Liat Gindes, MD contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Liat Gindes, MD, gindesl@smile.net.il
About this study
Official title: 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.
Read the 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
- Conditions
- Pregnancy
- Keywords
- to study the clinical application of 3D/4D ultrasound for fetal scanning, to study the clinical application of 3D/4D ultrasound for pelvic scanning;, to demonstrate how to optimally display the different organs., to correlate our findings with other diagnostic tools like MRI, CT;, to correlate our findings with clinical outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966537
- Sponsor's protocol ID
- SHEBA-09-4936-LG-CTIL
- Status last verified
- Aug 2009
- First submitted
- 26 Aug 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 3-Dimensional Ultrasound for Fetal Anomaly Scan.
- ClinicalTrials.gov ID
- NCT00966537
- Acronym / sponsor ID
- SHEBA-09-4936-LG-CTIL
- Conditions
- Pregnancy
- Keywords
- to study the clinical application of 3D/4D ultrasound for fetal scanning, to study the clinical application of 3D/4D ultrasound for pelvic scanning;, to demonstrate how to optimally display the different organs., to correlate our findings with other diagnostic tools like MRI, CT;, to correlate our findings with clinical outcome.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2008
- First posted
- 27 Aug 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant woman
Key inclusion criteria (1 listed)
- pregnant woman who come for fetal anomaly scan.
Key exclusion criteria (1 listed)
- -
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
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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.
Liat Gindes, MD contact
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 Pregnancy, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Aug 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liat Gindes, MD (gindesl@smile.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 27 Aug 2009.