HealthyNCT01178541
Simultaneous Measurement of Both Fetal's Lateral Ventricles of the Brain
An observational study of Healthy, run by Meir Medical Center at 1 site in Israel.
Trial summary
Study designed to measure simultaneously the width of both lateral ventricles of the fetal brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Dec 2012
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: low risk pregnant women
Who may be able to join
- low risk pregnant women
Who cannot join
- high risk pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Study designed to measure simultaneously the width of both lateral ventricles of the fetal brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.
Read the detailed description
Study will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.
- Conditions
- Healthy
- Keywords
- ventricles, fetal, brain, asymmetry
What is being measured
The primary outcome is the main question the study is designed to answer.
width of lateral ventricles along the pregnancy
constructing a graph of the width of the lateral ventricles according to the gestational weeks
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Vardimon, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178541
- Sponsor's protocol ID
- K111/2010
- Status last verified
- Mar 2012
- First submitted
- 8 Aug 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Measurement of Both Fetal's Lateral Ventricles of the Brain
- ClinicalTrials.gov ID
- NCT01178541
- Acronym / sponsor ID
- K111/2010
- Conditions
- Healthy
- Keywords
- ventricles, fetal, brain, asymmetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Aug 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.
Study designed to measure simultaneously the width of both lateral ventricles of the fetal brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.
Detailed description
Study will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- low risk pregnant women
Key inclusion criteria (1 listed)
- low risk pregnant women
Key exclusion criteria (1 listed)
- high risk pregnant women
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
width of lateral ventricles along the pregnancy
Time frame: one year
constructing a graph of the width of the lateral ventricles according to the gestational weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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.
David Vardimon, MD principal investigator
Clalit Health Services
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 Healthy, run by Meir 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: finished, as of the sponsor's last update on 20 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
width of lateral ventricles along the pregnancy (time frame: one year). It is what the study was designed to measure, not a finding.
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 20 Feb 2013.