Diagnosis Of Neurological Fetal Anomalies | NCT05058001

Studies
Diagnosis Of Neurological Fetal Anomalies

NCT05058001

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Sep 27, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Fetal Anomaly of Central Nervous System

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2021Estimated

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Sep 10, 2021

First Submission Date that Met QC Criteria

Sep 16, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2021

Last Update Posted Date

Sep 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bothina Zakria Elsayed, Assistant lecturer, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of sonography in the diagnosis of neurological fetal anomalies	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bothyna Za Elsayed, Assistant. lecturer	Contact	01004964952	020	bothina.zakria@med.sohag.edu.eg

Overall Officials

Name	Affiliation	Role
Bothyna Za Elsayed, Assistant lecturer	Sohag University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicine		Sohag	Sohag Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 9, 2023
Reset	Feb 29, 2024

Submission Tracking

Estimated Results First Submitted Date

Jul 9, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 9, 2023			Feb 29, 2024