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RecruitingNCT05771922Updated Apr 24, 2024

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

An observational study in Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases, sponsored by Woman's Health University Hospital, Egypt. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 28 Years. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Woman's Health University Hospital, Egypt · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
20 Years to 28 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases
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In context

Central Nervous System Diseases

386 studies on the registry are indexed under Central Nervous System Diseases; 104 are open to participants now.

This study's planned enrollment of 150 is close to the median of 139 across 73 observational studies indexed under Central Nervous System Diseases.

Browse Central Nervous System Diseases studies →

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 28 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Low risk pregnancy

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testHigh-resolution ultrasonography

    High-resolution ultrasonography to detect fetal CNS anomalies

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

  2. 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 .

    Time frame: 2 years

  3. 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 .

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05771922
Lead sponsor
Woman's Health University Hospital, Egypt
Responsible party
Professor Atef Darwish (Senior consultant of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt) — Principal investigator
First posted
Mar 16, 2023
Start date
Nov 30, 2024 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 20, 2026 (estimated)
Last update
Apr 24, 2024

Study contacts

Atef Darwish, Prof
Contact
atef_darwish@yahoo.com
0201001572723

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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