## Protocol Section
### Identification Module
**NCT ID:** NCT05778279

**Brief Title:** Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies

**Official Title:** Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies

#### Organization Study ID Info
**ID:** woman's Health University H
#### Organization
**Class:** OTHER
**Full Name:** Woman's Health University Hospital, Egypt
### Status Module
#### Completion Date
**Date:** 2026-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-03-21
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-20
**Study First Submit QC Date:** 2023-03-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Woman's Health University Hospital, Egypt

#### Responsible Party

**Investigator Affiliation:** Woman's Health University Hospital, Egypt

**Investigator Full Name:** Professor Atef Darwish

**Investigator Title:** professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.

**Detailed Description:** The neural system malformation is one of the more common congenital anomalies encountered in pregnancy. They represent about 0.3-1 percent of all live births. During a prenatal anomaly scan, detection of CNS malformations is important, especially since these anomalies have a poor prognosis and are also associated with genetic syndromes or chromosomal anomalies. Such malformations have clinical importance because they are associated with high rates of morbidity and mortality, influencing the neurocognitive and motor development of the survivors, who may have lifelong sequelae. Thus, it's extremely important to assess the fetal CNS during the prenatal period in order to identify any changes in its development and give appropriate advice to parents regarding pregnancy follow-up. Also, it is vital to explore options for fetal therapy and the timing/type of delivery, as well as postnatal treatment and prognosis.

The fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.

### Conditions Module

**Conditions:**

- Ultrasound Therapy; Complications

- Anomaly

- Central Nervous System Diseases

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** High-resolution ultrasonography to detect fetal CNS anomalies

**Name:** High-resolution ultrasonography

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** tO DETECT PREVELANCE OF FETAL BRAIN CONGENITAL ANOMALIES UTILIZING STANDARD THREE-AXIAL VIEW (TRANSTHALAMIC, TRANSVENTRICULAR AND TRANSCEREBELLER ) WITH 2D ULTRASONOGRAPHY .

**Measure:** PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .

**Time Frame:** 2 years

**Description:** PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS (TRANCALVERIAL AND TRANSGENU AND SPELNIUM) TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .

**Measure:** PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .

**Time Frame:** 2 years

**Description:** PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY BY SURFACE 3 D, MULTIPLANNER AND MULTISLICE VIEWS .

**Measure:** PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY .

**Time Frame:** 2 YEARS

### Eligibility Module

**Eligibility Criteria:** 1. Inclusion criteria:
2. Suspicion of CNS or spinal malformation at routine screening ultrasound
3. Suspicion of CNS or spinal malformation at nuchal translucency scan
4. Family history of inheritable CNS spinal malformations
5. Previous pregnancy complicated by fetal brain or spinal malformation
6. Fetus with congenital heart disease
7. Monochorionic twins
8. Suspected congenital intrauterine infection Exposure to teratogens known to affect neurogenesis

Exclusion Criteria:

* Low risk pregnancy

**Maximum Age:** 28 Years

**Minimum Age:** 20 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** all pregnant women with gestational age between 20 and 28 weeks coming to outpatient clinic for antenatal care with one or more of the following inclusion criteria will be included in this study.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dodydana12@gmail.com

**Name:** Dina Darwish, MRCOG

**Phone:** 0201001572723

**Role:** CONTACT

**Contact 2:**

**Name:** Atef Darwish

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Assiut

**Contacts:**

***Contact 1:***

- **Email:** atef_darwish@yahoo.com

- **Name:** Atef MM Darwish, MD PhD

- **Phone:** 0201001572723

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Woman's Health University Hospital

**Status:** RECRUITING

**Zip:** 71111

#### Overall Officials

**Official 1:**

**Affiliation:** Woman's Health University Hospital

**Name:** Dina Darwish, MRCOG

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12

- Name: Congenital Abnormalities

- Relevance: HIGH

- As Found: Anomalies

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: HIGH

- As Found: Central Nervous System Diseases

- ID: M12365

- Name: Nervous System Malformations

- Relevance: HIGH

- As Found: Nervous System Anomalies

### Condition Browse Module - Meshes

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009421

- Term: Nervous System Malformations

- ID: D000000013

- Term: Congenital Abnormalities

### Misc Info Module

- Version Holder: 2024-05-24
