Outcome of Babies With Asymetry of Lateral Brain Ventricles

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Hillel Yaffe Medical Center
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014