Clinical trial NCT05778279: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasound Therapy; Complications
Anomaly
Central Nervous System Diseases
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .
timeFrame: 2 years
measure: PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .
timeFrame: 2 years
measure: PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY .
timeFrame: 2 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health University Hospital
Study officials:
affiliation: Woman's Health University Hospital
name: Dina Darwish, MRCOG
role: PRINCIPAL_INVESTIGATOR
References: