Outcome of Babies With Asymetry of Lateral Brain Ventricles
This study is not yet open for participant recruitment.
Verified November 2012 by Hillel Yaffe Medical Center
Sponsor:
Hillel Yaffe Medical Center
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01724281
First received: November 6, 2012
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Lateral Ventricles of Fetuses at Mid Trimester |
Other: No intervention, only follow up |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Outcome of Babies With Asymetry of Lateral Brain Ventricles |
Further study details as provided by Hillel Yaffe Medical Center:
Primary Outcome Measures:
- Lateral ventricles width after delivery [ Time Frame: 2 years ] [ Designated as safety issue: No ]The investigators will follow up on brain ultrasound of babies with normal width discrepant lateral brain ventricles
Secondary Outcome Measures:
- Neurologic examination of babies with discrepant but normal lateral ventricles [ Time Frame: 2 years ] [ Designated as safety issue: No ]After delivery, a neurologic examination will be carried out on all babies with discrepant but normal lateral ventricles
Biospecimen Retention: None Retained
not relevant
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
pregnant women between 19-30 weeks gestational age
No intervention, only follow up
|
Other: No intervention, only follow up |
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
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
women at 19-30 weeks who attend ultrasound exam and diagnosed with asymetry of lateral brain ventricles.
Criteria
Inclusion Criteria:
- Healthy pregnant women between 19-30 weeks gestational age and asymetry of lateral ventricles
Exclusion Criteria:
- Lateral ventricles >10 m"m
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724281
Contacts
| Contact: Alon Shrim, MD | +972506246988 | alon.shrim@gmail.com |
Locations
| Israel | |
| Hillel Yaffe Medical Center | Not yet recruiting |
| Hadera, Israel, 38101 | |
| Contact: Alon Shrim, MD +972506246988 alon.shrim@gmail.com | |
| Principal Investigator: Alon Shrim, MD | |
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information
No publications provided
| Responsible Party: | Hillel Yaffe Medical Center |
| ClinicalTrials.gov Identifier: | NCT01724281 History of Changes |
| Other Study ID Numbers: | 0059-12 |
| Study First Received: | November 6, 2012 |
| Last Updated: | November 8, 2012 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Hillel Yaffe Medical Center:
|
lateral ventricles Asymetry |
ClinicalTrials.gov processed this record on May 23, 2013