Fetal AnomalyNCT06410391
Fetal Brain Ultrasound
An observational study of Fetal Anomaly, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of our study is to determine the range of frontal horn sizes (both upside and downside) in healthy fetuses over gestation and to determine how far FHs are from the midline . Also to determine the range of cavum septi pellucidi and Corpus callosum sizes . Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Fetal Anomaly
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2024to 11 Dec 2024
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: All healthy pregnant women came to fetal medicine unit at 15 to 36 weeks
Who may be able to join
- pregnant woman 15 weeks to 36 weeks
Who cannot join
- congenital malformations
- Multiple pregnancy
- intrauterine infection
- fetuses with Fetal growth restriction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Brain Sonographic Measurements and Normograms in Healthy Fetuses During Second and Third Trimesters
The aim of our study is to determine the range of frontal horn sizes (both upside and downside) in healthy fetuses over gestation and to determine how far FHs are from the midline . Also to determine the range of cavum septi pellucidi and Corpus callosum sizes . Also, to determine whether the maternal body mass index (BMI) affects rates of visualized and non-visualized CSP and CC.
Read the detailed description
Fetal central nervous system (CNS) abnormalities are among the most commonly encountered congenital abnormalities . Many different methods can be used to obtain prenatal diagnoses, including ultrasound (US), which is one of the most commonly used methods .Neonatal survival rates have increased over the last decades leading to increased number of infants with adverse neurodevelopmental outcomes, including cognitive, motor impairments and behavioral and learning difficulties later in life . Recent studies demonstrated that signs of abnormal neurological development are already present at birth .
Frontal horns (FHs) are the most anterior portions of the lateral ventricles, on each side the cavum septi pellucidi (CSP). In accordance with practice parameters released as early as 1985 by the American Institute of Ultrasound in Medicine, American College of Obstetrics and Gynecology, and Society of Radiologists in Ultrasound, the CSP is examined in screening fetal ultrasound (US) examinations in the biparietal diameter view . Frontal horns (FH) are also visualized in the same plane. Abnormal morphologic characteristics of the FHs such as enlargement, squaring, spearing, and splaying may have an association with congenital intracranial anomalies such as holoprosencephaly, schizencephaly and agenesis of the corpus callosum .
The corpus callosum (CC) is the largest interhemispheric white matter commissure of the human brain . It is a sensitive indicator of normal brain development and maturation
- Conditions
- Fetal Anomaly
- Being tested
- Ultrasound
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
Gestational age, biparietal diameter and head circumference are measured. then 2 techniques are used according to the 2007 International Society of Ultrasound in Obstetrics and Gynecology guidelines for a US evaluation of the fetal central nervous system (CNS) (10) : 1- the axial transventricular technique including the posterior portions of the lateral ventricles, falx, CSP, and Frontal horn 2- the trans-cerebellar technique, including the cerebellum, cisternal magna, cerebellar peduncles, CSP, and FHs. CSP visualization and width, FH width, anterior horn width (AHW), center from the horn distance (CFHD), upside and downside measurement.
The corpus callosum is identified in the midsagittal plane. The image selected for CC measurement in addition to cerebellar vermis and cisterna magna
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the range of lateral ventricles diameter in healthy fetuses at different gestational ages.,
Diameter of Lateral ventricles measured by ultrasound in millimeters
Measured: 5 months
Secondary outcomes (1)
measurement of Cavum septum and Corpus callosum
Length of Cavum septum and Corpus callosum measured by ultrasound in millimeters
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start15 Jun 2024
- Primary completion2 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal AnomalyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal M.fekry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410391
- Sponsor's protocol ID
- FBUS
- Status last verified
- Jun 2024
- First submitted
- 3 May 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Brain Sonographic Measurements and Normograms in Healthy Fetuses During Second and Third Trimesters
- ClinicalTrials.gov ID
- NCT06410391
- Acronym / sponsor ID
- FBUS
- Conditions
- Fetal Anomaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 13 May 2024 (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 aim of our study is to determine the range of frontal horn sizes (both upside and downside) in healthy fetuses over gestation and to determine how far FHs are from the midline . Also to determine the range of cavum septi pellucidi and Corpus callosum sizes . Also, to determine whether the maternal body mass index (BMI) affects rates of visualized and non-visualized CSP and CC.
Detailed description
Fetal central nervous system (CNS) abnormalities are among the most commonly encountered congenital abnormalities . Many different methods can be used to obtain prenatal diagnoses, including ultrasound (US), which is one of the most commonly used methods .Neonatal survival rates have increased over the last decades leading to increased number of infants with adverse neurodevelopmental outcomes, including cognitive, motor impairments and behavioral and learning difficulties later in life . Recent studies demonstrated that signs of abnormal neurological development are already present at birth .
Frontal horns (FHs) are the most anterior portions of the lateral ventricles, on each side the cavum septi pellucidi (CSP). In accordance with practice parameters released as early as 1985 by the American Institute of Ultrasound in Medicine, American College of Obstetrics and Gynecology, and Society of Radiologists in Ultrasound, the CSP is examined in screening fetal ultrasound (US) examinations in the biparietal diameter view . Frontal horns (FH) are also visualized in the same plane. Abnormal morphologic characteristics of the FHs such as enlargement, squaring, spearing, and splaying may have an association with congenital intracranial anomalies such as holoprosencephaly, schizencephaly and agenesis of the corpus callosum .
The corpus callosum (CC) is the largest interhemispheric white matter commissure of the human brain . It is a sensitive indicator of normal brain development and maturation
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All healthy pregnant women came to fetal medicine unit at 15 to 36 weeks
Key inclusion criteria (1 listed)
- pregnant woman 15 weeks to 36 weeks
Key exclusion criteria (4 listed)
- congenital malformations
- Multiple pregnancy
- intrauterine infection
- fetuses with Fetal growth restriction
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 |
|---|---|---|
| UltrasoundGestational age, biparietal diameter and head circumference are measured. then 2 techniques are used according to the 2007 International Society of Ultrasound in Obstetrics and Gynecology guidelines for a US evaluation of the fetal central nervous system (CNS) (10) : 1- the axial transventricular technique including the posterior portions of the lateral ventricles, falx, CSP, and Frontal horn 2- the trans-cerebellar technique, including the cerebellum, cisternal magna, cerebellar peduncles, CSP, and FHs. CSP visualization and width, FH width, anterior horn width (AHW), center from the horn distance (CFHD), upside and downside measurement. The corpus callosum is identified in the midsagittal plane. The image selected for CC measurement in addition to cerebellar vermis and cisterna magna | Radiation | – |
Primary outcome
Determine the range of lateral ventricles diameter in healthy fetuses at different gestational ages.,
Time frame: 5 months
Diameter of Lateral ventricles measured by ultrasound in millimeters
1 secondary outcome
measurement of Cavum septum and Corpus callosum
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fetal Anomaly, run by Assiut University 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 4 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: finished, as of the sponsor's last update on 18 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the range of lateral ventricles diameter in healthy fetuses at different gestational ages., (time frame: 5 months). 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 18 Dec 2024.