Ultrasound Therapy; Complications Anomaly Central Nervous System DiseasesNCT05771922
Implication of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
An observational study of Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 28 years, women only
- Conditions the study is for
- Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases
- What is being tested?
- High-resolution ultrasonography
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2024to 20 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 28 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Low risk pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Woman's Health University Hospital
Asyut, 71111
Atef MM Darwish, MD PhD, 0201001572723, atef_darwish@yahoo.com
About this study
Official title: Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
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.
- Being tested
- High-resolution ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution ultrasonographyDiagnostic test
High-resolution ultrasonography to detect fetal CNS anomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 .
Measured: 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 .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start30 Nov 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; Complications Anomaly Central Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771922
- Sponsor's protocol ID
- 1234567
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
- ClinicalTrials.gov ID
- NCT05771922
- Acronym / sponsor ID
- 1234567
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 28 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Low risk pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-resolution ultrasonographyHigh-resolution ultrasonography to detect fetal CNS anomalies | Diagnostic test | – |
Primary outcome
PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY
Time frame: 2 years
tO DETECT PREVELANCE OF FETAL BRAIN CONGENITAL ANOMALIES UTILIZING STANDARD THREE-AXIAL VIEW (TRANSTHALAMIC, TRANSVENTRICULAR AND TRANSCEREBELLER ) WITH 2D ULTRASONOGRAPHY
PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY
Time frame: 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 .
PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY .
Time frame: 2 years
PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY BY SURFACE 3 D, MULTIPLANNER AND MULTISLICE VIEWS .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atef Darwish, Prof (0201001572723, atef_darwish@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.