- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058001
Diagnosis Of Neurological Fetal Anomalies
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
Conditions
Detailed Description
- Type of the study: This is a descriptive cross-sectional study
- Study Setting: 300 patients coming for antenatal care at sohag governorate undergo routine second trimester scan.
- patients and methods:
Inclusion criteria:
- All pregnant females of 18 to 45 years old.
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Bothyna Za Elsayed, Assistant. lecturer
- Phone Number: 020 01004964952
- Email: bothina.zakria@med.sohag.edu.eg
Study Locations
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سوهاج
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Sohag, سوهاج, Egypt
- Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Bothyna Za Elsayed, Assistant lecturer, Sohag University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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