Diagnosis Of Neurological Fetal Anomalies

September 16, 2021 updated by: Bothina Zakria Elsayed, Sohag University

Accuracy of Prenatal Ultrasonography in The Diagnosis Of Neurological Fetal Anomalies

This is a descriptive cross-sectional study 300 patients coming for antenatal care at sohag governorate undergo mid anatomical scan.

Samples 300 pregnant women have mid anatomical scan at 20-22 weeks as routine antenatal care and Examination of the fetal CNS will be performed with a high resolution two dimensional ultrasound machine (Voluson E8) equipped with a RAB 4 to 8MHz multifrequency transabdominal Probe. Four standard recommended views-transventricular, falx, cavum, and posterior fossa or transcerebellar views-provide an overview of fetal intracranial anatomy during the second trimester anatomy scan.

Follow-up information will be obtained in all cases, and all infants will be considered healthy by pediatric examination. In selected cases, postnatal single-shot fast spin-echo magnetic resonance (MR) imaging will be performed as integrated, complementary investigation.to confirm diagnosis.

Study Overview

Status

Not yet recruiting

Detailed Description

  1. Type of the study: This is a descriptive cross-sectional study
  2. Study Setting: 300 patients coming for antenatal care at sohag governorate undergo routine second trimester scan.
  3. patients and methods:

Inclusion criteria:

  1. All pregnant females of 18 to 45 years old.
  2. gestational age of 20- 22 gestational week .

Exclusion criteria:

1-age less than18years and more than 45 years. gestational age less or more than20- 22 weeks. Samples Methods 300 pregnant women low risk pregnancy will be scanned at 20-22 weeks as routine antenatal care and Examination of the fetal CNS will be performed with a high resolution two dimintional ultrasound machine (Voluson E8) equipped with a RAB 4 to 8MHz multifrequency transabdominal Probe. Four standard recommended views-transventricular, falx, cavum, and posterior fossa or transcerebellar views-provide an overview of fetal intracranial anatomy during the second trimester anatomy scan.

Follow-up information will be obtained in all cases, and all infants will be considered healthy by pediatric examination. In selected cases, postnatal single-shot fast spin-echo magnetic resonance (MR) imaging will be performed as integrated, complementary investigation.to confirm diagnosis.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Contact

Study Locations

    • سوهاج
      • Sohag, سوهاج, Egypt
        • Medicine

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

300 pregnant women have mid anatomical scan at 20-22 weeks as routine antenatal care and Examination of the fetal CNS will be performed with a high resolution two dimintional ultrasound machine (Voluson E8) equipped with a RAB 4 to 8MHz multifrequency transabdominal Probe.

Description

Inclusion Criteria:

  • All pregnant females of 18 to 45 years old.
  • gestatioal age of 20- 22 gestational week .

Exclusion Criteria:

  • age less than18years and more than 45 years.
  • gestational age less or more than20- 22 weeks.

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
Accuracy of sonography in the diagnosis of neurological fetal anomalies
Time Frame: From 20 _ 22 gestational age ...confirmation occursat birth till 1 week post natal

Investigator compares the accuracy of songraphy in the diagnosis of neurological fetal anomalies with post natal diagnosis by either clinically or by MRIThis is a descriptive cross-sectional study 2- Study Setting: 300 patients coming for antenatal care at sohag governorate undergo mid anatomical scanExamination of the fetal CNS will be performed with a high resolution two dimintional ultrasound machine (Voluson E8) equipped with a RAB 4 to 8MHz multifrequency transabdominal Probe. Four standard recommended views-transventricular, falx, cavum, and posterior fossa or transcerebellar views-provide an overview of fetal intracranial anatomy during the second trimester anatomy scan.

After birth ,investigator reports anomalies clinically or after consultation of pediatric department.

From 20 _ 22 gestational age ...confirmation occursat birth till 1 week post natal

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Bothyna Za Elsayed, Assistant lecturer, Sohag University

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 (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-09-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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