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Fetal Brain Asymmetry: in Utero and Early Neonatal Follow up

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ClinicalTrials.gov Identifier: NCT01707875
Recruitment Status : Terminated (Difficulties in recruiting)
First Posted : October 16, 2012
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Fetal Ventricle Brain Asymmetry Other: fetal brain neurosonography

Study Design

Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : November 2012
Primary Completion Date : July 2014
Study Completion Date : July 2014
Groups and Cohorts

Group/Cohort Intervention/treatment
fetal ventricle brain asymmetry Other: fetal brain neurosonography
fetal brain neurosonography according to the ISUG guidelines


Outcome Measures

Eligibility Criteria

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
More Information

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