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Quantification of Fetal Brains' Sulci Along Gestation

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. Identifier: NCT03168932
Recruitment Status : Unknown
Verified June 2017 by Yuval Ginsberg, MD, Rambam Health Care Campus.
Recruitment status was:  Active, not recruiting
First Posted : May 30, 2017
Last Update Posted : June 7, 2017
Information provided by (Responsible Party):
Yuval Ginsberg, MD, Rambam Health Care Campus

Brief Summary:

Gyrogenesis is an ontogenic process that transforms the smooth (lissencephalic) cortex toward its mature, convolved (gyrencephalic) state. A tortuous, branching and deepening pattern of sulci and fissures outlines for a well-developed cortex.

The aim of this study is to find an algorithm that can detect the sulci in ultrasound images of fetus' brain and measure the length of it. This algorithm can be used for research demands like learning the development of the brain from embryo stages until the birth of the baby

Condition or disease
Fetal Brain Injury

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Detecting and Quantifying Sulci and White Matter in Fetus' Brain Along the Third Stage of Gestation
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : January 2018

Primary Outcome Measures :
  1. morphological changes of the developing fetal brain [ Time Frame: 9 months ]
    Ultrasound measurements of the fetal brain sulcation by a computerized algorithm

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women between the age of 18-35 at gestational age of 25-40 weeks

Inclusion Criteria:

  • Pregnant women between the ages of 18-35
  • Gestational age between 25-40 weeks
  • Low risk pregnancies

Exclusion Criteria:

  • Multiple gestation
  • Fetal brain abnormality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03168932

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Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Additional Information:

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Responsible Party: Yuval Ginsberg, MD, Principal investigator, Rambam Health Care Campus Identifier: NCT03168932    
Other Study ID Numbers: 0398-14-RMB
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries