Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies

• Sponsor: Woman's Health University Hospital, Egypt (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05778279
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 22.1
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasound Therapy; Complications; Anomaly; Central Nervous System Diseases	Diagnostic Test: High-resolution ultrasonography

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
• Anticipated Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Feb 1, 2025

Outcome Measures

Primary Outcome Measures

1. PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY . [2 years]

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

2. PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY . [2 years]

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

3. PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY . [2 YEARS]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 28 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woman's Health University Hospital	Assiut		Egypt	71111

Sponsors and Collaborators

• Woman's Health University Hospital, Egypt

Investigators

• Principal Investigator: Dina Darwish, MRCOG, Woman's Health University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Atef Darwish, professor, Woman's Health University Hospital, Egypt
• ClinicalTrials.gov Identifier: NCT05778279
• Other Study ID Numbers: woman's Health University H
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 21, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nervous System Diseases; Central Nervous System Diseases; Nervous System Malformations; Congenital Abnormalities

Study Results

No Results Posted as of Mar 21, 2023