Normal Fetal Brain SulcationNCT01168843
Computer Program for Evaluation of the Symmetry Between the Primary Sulci of the Two Fetal Brain Hemispheres and Midsagittal Fetal Head Biometry Using 3-dimensional Ultrasound Planes.
An observational study of Normal Fetal Brain Sulcation, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes This retrospective study is based on the computerized analysis of the orthogonal fetal brain planes. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Normal Fetal Brain Sulcation
- What is being tested?
- computerized analysis of sonographic images
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: normal pregnancies in 2nd and 3rd trimester
Who may be able to join
- normal pregnancies
- proper dating
Who cannot join
- complications of pregnancy
- fetal malformations
Trial locations and contacts
1 site in 1 country.
Israel1 site
Bnai Zion Medical Center
Haifa, 31048
Zvi Leibovitz, MD, 97248359200, zleibovitz@b-zion.org.il
Zvi Leibovitz, MD
About this study
Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes
This retrospective study is based on the computerized analysis of the orthogonal fetal brain planes.
The images are obtained from the digital archive of the fetal sonographic examinations done in Bnai Zion Medical Center.
In addition, midsagittal measurements of fetal head will be obtained from this archive of 3-dimensional images.
Study measurements will provide the quantitative parameters of normal fetal brain sulcation. Normal fetal head growth in midsagittal plane will be studied also.
- Conditions
- Normal Fetal Brain Sulcation
- Being tested
- computerized analysis of sonographic images
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized analysis of sonographic imagesOther
Evaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes
| Study group | Role | What they receive |
|---|---|---|
| normal pregnant | Not described Receives: Other: computerized analysis of sonographic images |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Fetal Brain SulcationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168843
- Sponsor's protocol ID
- 0027-10-BNZ
- Status last verified
- Jul 2010
- First submitted
- 22 Jul 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Program for Evaluation of the Symmetry Between the Primary Sulci of the Two Fetal Brain Hemispheres and Midsagittal Fetal Head Biometry Using 3-dimensional Ultrasound Planes.
- ClinicalTrials.gov ID
- NCT01168843
- Acronym / sponsor ID
- 0027-10-BNZ
- Conditions
- Normal Fetal Brain Sulcation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Oct 2010
- First posted
- 23 Jul 2010 (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.
Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes
This retrospective study is based on the computerized analysis of the orthogonal fetal brain planes.
The images are obtained from the digital archive of the fetal sonographic examinations done in Bnai Zion Medical Center.
In addition, midsagittal measurements of fetal head will be obtained from this archive of 3-dimensional images.
Study measurements will provide the quantitative parameters of normal fetal brain sulcation. Normal fetal head growth in midsagittal plane will be studied also.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal pregnant | – | Other: computerized analysis of sonographic images |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- normal pregnancies in 2nd and 3rd trimester
Key inclusion criteria (2 listed)
- normal pregnancies
- proper dating
Key exclusion criteria (2 listed)
- complications of pregnancy
- fetal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized analysis of sonographic imagesEvaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes | Other | normal pregnant |
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 24 Aug 2010.
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.
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 Normal Fetal Brain Sulcation, run by Bnai Zion 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 2 inclusion and 2 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 24 Aug 2010. 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 Zvi Leibovitz, MD (97248359200, zleibovitz@b-zion.org.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 24 Aug 2010.