Quantification of Fetal Brains' Sulci Along Gestation

June 5, 2017 updated by: Yuval Ginsberg, MD, Rambam Health Care Campus

Detecting and Quantifying Sulci and White Matter in Fetus' Brain Along the Third Stage of Gestation

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy pregnant women between the age of 18-35 at gestational age of 25-40 weeks

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphological changes of the developing fetal brain
Time Frame: 9 months
Ultrasound measurements of the fetal brain sulcation by a computerized algorithm
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0398-14-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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