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

NCT05771922 | Recruiting

• 1 other identifier: 1234567
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

High-resolution ultrasonography DIAGNOSTIC_TEST

High-resolution ultrasonography to detect fetal CNS anomalies

Eligibility Criteria

• Age: 20 Years - 28 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Suspicion of CNS or spinal malformation at routine screening ultrasound Suspicion of CNS or spinal malformation at nuchal translucency scan Family history of inheritable CNS spinal malformations Previous pregnancy complicated by fetal brain or spinal malformation Fetus with congenital heart disease Monochorionic twins Suspected congenital intrauterine infection Exposure to teratogens known to affect neurogenesis

You may not qualify if:

• Low risk pregnancy

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

RECRUITING

Central Study Contacts

Atef Darwish, Prof

CONTACT

0201001572723; atef_darwish@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: November 30, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 20, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)