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

Central Nervous System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778279
• Other study ID #: woman's Health University H
• Status: Recruiting
• Start date: September 30, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: April 2024
• Source: Woman's Health University Hospital, Egypt
• Contact: Dina Darwish, MRCOG
• Phone: 0201001572723
• Email: dodydana12[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Congenital Abnormalities
• Nervous System Diseases
• Nervous System Malformations
• Ultrasound Therapy; Complications

Intervention

Diagnostic Test:
• High-resolution ultrasonography
High-resolution ultrasonography to detect fetal CNS anomalies

Locations

Country	Name	City	State
Egypt	Woman's Health University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .	tO DETECT PREVELANCE OF FETAL BRAIN CONGENITAL ANOMALIES UTILIZING STANDARD THREE-AXIAL VIEW (TRANSTHALAMIC, TRANSVENTRICULAR AND TRANSCEREBELLER ) WITH 2D ULTRASONOGRAPHY .	2 years
Primary	PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .	PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS (TRANCALVERIAL AND TRANSGENU AND SPELNIUM) TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .	2 years
Primary	PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY .	PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY BY SURFACE 3 D, MULTIPLANNER AND MULTISLICE VIEWS .	2 YEARS