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Fetal Brain Asymmetry: in Utero and Early Neonatal Follow up

This study has been terminated.
(Difficulties in recruiting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707875
First Posted: October 16, 2012
Last Update Posted: June 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
  Purpose

Fetal brain asymmetry is considered a normal developmental processes. The size and shape of the lateral ventricles are interdependence with the brain parenchyma. Abnormal development of the fetal brain may cause unilateral or bilateral ventriculomegaly. Fetal cerebral ventricle measurement is one of the most frequently used sonographic tool for the evaluation of brain development. It is easier to evaluate and measure the distal cerebral ventricle, and therefore data concerning the normal range of asymmetry and the normal progress of the asymmetry are limited.

The objective of the study is to follow up the incidental finding of fetal ventricle brain asymmetry between 19-30 weeks of pregnancy.


Condition Intervention
Fetal Ventricle Brain Asymmetry Other: fetal brain neurosonography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by HaEmek Medical Center, Israel:

Enrollment: 6
Study Start Date: November 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fetal ventricle brain asymmetry Other: fetal brain neurosonography
fetal brain neurosonography according to the ISUG guidelines

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with fetal ventricle brain asymmetry
Criteria

Inclusion Criteria:

  • 18-42 years old pregnant women
  • 19-30 weeks of pregnancy
  • No medical history of chronic disease
  • No medical history of drug therapy
  • No other findings on ultrasound examination
  • Low risk pregnancy

Exclusion Criteria:

  • Fetal malformation
  • Chronic maternal disease
  • Fetal chromosomal aberration
  • suspected fetal infection
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01707875     History of Changes
Other Study ID Numbers: EMC-0062-12-CTIL
First Submitted: October 14, 2012
First Posted: October 16, 2012
Last Update Posted: June 16, 2015
Last Verified: July 2012