- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01724281
Outcome of Babies With Asymetry of Lateral Brain Ventricles
November 8, 2012 updated by: Hillel Yaffe Medical Center
The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd trimester of normal width and asymetry of lateral brain ventricles
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Women who will attend 2nd or 3rd ultrasound prenatal scans will be included.
Women where the fetus would be diagnosed with lateral ventricles that are normal width (<10 m"m) but discrepacy of >3 m"m will be followed up after delivery by head ultrasound and neurologic exam
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38101
- Hillel Yaffe Medical Center
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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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
women at 19-30 weeks who attend ultrasound exam and diagnosed with asymetry of lateral brain ventricles.
Description
Inclusion Criteria:
- Healthy pregnant women between 19-30 weeks gestational age and asymetry of lateral ventricles
Exclusion Criteria:
- Lateral ventricles >10 m"m
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pregnant women between 19-30 weeks gestational age
No intervention, only follow up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lateral ventricles width after delivery
Time Frame: 2 years
|
The investigators will follow up on brain ultrasound of babies with normal width discrepant lateral brain ventricles
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurologic examination of babies with discrepant but normal lateral ventricles
Time Frame: 2 years
|
After delivery, a neurologic examination will be carried out on all babies with discrepant but normal lateral ventricles
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2012
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
November 6, 2012
First Submitted That Met QC Criteria
November 8, 2012
First Posted (Estimate)
November 9, 2012
Study Record Updates
Last Update Posted (Estimate)
November 9, 2012
Last Update Submitted That Met QC Criteria
November 8, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0059-12
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.