Congenital AnomaliesNCT03888794
MRI Versus Four Dimensional Ultrasound in Detection of CNS Fetal Congenital Anomalies
An observational study of Congenital Anomalies, run by Assiut University.
Trial summary
Congenital central nervous system (CNS) anomalies are common and most devastating. They occur in frequency of about 1.4 to 1.6 per 1000 live births but are seen in about 3-6% of still births.They account for 40% of deaths of all infants in the first year of life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Congenital Anomalies
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2019to 30 Jun 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant females referred from obstetric department with either suspected or detected fetal anomalies on ultrasound.
Who may be able to join
- All pregnancies with either suspected or detected fetal anomalies on ultrasound excluding first trimester pregnancies (to allow completion of period of organogenesis).
- Pregnant females with past or family history of congenital fetal abnormality.
Who cannot join
- Pregnancies with normal antenatal US.
- pregnancies in first trimester
- Claustrophobic patients.
- contraindication to MRI as cochlear implants and pacemakers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Magnetic Resonance Imaging Versus Four Dimensional Ultrasound in Detection of Central Nervous System Fetal Congenital Anomalies
Congenital central nervous system (CNS) anomalies are common and most devastating. They occur in frequency of about 1.4 to 1.6 per 1000 live births but are seen in about 3-6% of still births.They account for 40% of deaths of all infants in the first year of life. In survivors, they cause a variety of neurological disorders, mental retardation or drug resistant epilepsy.
CNS anomalies are usually compatible with life, prolonged hospitalization, higher health care costs, uncertain future life quality and significant burden to families and society.
Read the detailed description
Early detection of congenital CNS anomalies gives time available for the clinician and parents to plan about the outcome of pregnancy.
Prenatal ultrasound has been well established for decades as the primary technique for evaluating the developing fetus in normal as well as in high risk cases. Advantages of US include widespread availability, relatively low cost and quick, lack of harmful effect to fetus or mother and real time imaging.
Although ultrasound can characterize many anomalies accurately, it has many limitations as operator dependent, small field of view, and relatively poor soft-tissue contrast, beam attenuation by maternal adipose tissue and fetal bone, limited visualization of posterior fossa after 33 weeks gestation because of calvarial calcification. Also, ultrasound relies heavily on fetal positioning and presence of sufficient amniotic fluid to provide an adequate acoustic window fetus So, US findings are occasionally incomplete or inconclusive to guide treatment choices.
Fetal brain MRI became embraced as a clinically important imaging technique useful for fetal assessment, which is helpful in formulating prognosis and perinatal management and can detect occult abnormalities in up to 50% of cases for certain indications.
It can overcome many of ultrasound limitations as it is not limited by maternal obesity, fetal position, or oligohydramnios. Additionally, it has better soft tissue contrast resolution, as well as the ability to distinguish individual fetal structures such as brain, lung, liver, kidney, and bowel. In addition, visualization of the brain is not restricted by the ossified skull. Moreover, MRI provides multiplanar imaging as well a larger field of view, facilitating examination of fetuses with large or complex anomalies.
- Conditions
- Congenital Anomalies
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Magnetic Resonance Imaging on pregnant women after 18 weeks of pregnancy with US diagnosis of congenital CNS fetal abnormality.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular size
assess the ventricular size by measuring the anteroposterior diameter of the fourth ventricle, the width of the third ventricle, and the transverse diameter of the lateral ventricles on the coronal images.
Measured: baseline
Secondary outcomes (1)
Correlate MRI findings with Ultrasound findings.
to correlate fetal biometry and ventricular size with ultrasound findings.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start20 May 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital AnomaliesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Kamal Mohamed, Assiut University
- Investigators
- Nehal Mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888794
- Sponsor's protocol ID
- MRIUSCNS
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Onkar D, Onkar P, Mitra K. Evaluation of Fetal Central Nervous System Anomalies by Ultrasound and Its Anatomical Co-relation. J Clin Diagn Res. 2014 Jun;8(6):AC05-7. doi: 10.7860/JCDR/2014/8052.4437. Epub 2014 Jun 20.
PubMed 25120962Manganaro L, Bernardo S, Antonelli A, Vinci V, Saldari M, Catalano C. Fetal MRI of the central nervous system: State-of-the-art. Eur J Radiol. 2017 Aug;93:273-283. doi: 10.1016/j.ejrad.2017.06.004. Epub 2017 Jun 17.
PubMed 28668426Sefidbakht S, Dehghani S, Safari M, Vafaei H, Kasraeian M. Fetal Central Nervous System Anomalies Detected by Magnetic Resonance Imaging: A Two-Year Experience. Iran J Pediatr. 2016 Jun 6;26(4):e4589. doi: 10.5812/ijp.4589. eCollection 2016 Aug.
PubMed 27729957
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Versus Four Dimensional Ultrasound in Detection of Central Nervous System Fetal Congenital Anomalies
- ClinicalTrials.gov ID
- NCT03888794
- Acronym / sponsor ID
- MRIUSCNS
- Conditions
- Congenital Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 25 Mar 2019 (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.
Congenital central nervous system (CNS) anomalies are common and most devastating. They occur in frequency of about 1.4 to 1.6 per 1000 live births but are seen in about 3-6% of still births.They account for 40% of deaths of all infants in the first year of life. In survivors, they cause a variety of neurological disorders, mental retardation or drug resistant epilepsy.
CNS anomalies are usually compatible with life, prolonged hospitalization, higher health care costs, uncertain future life quality and significant burden to families and society.
Detailed description
Early detection of congenital CNS anomalies gives time available for the clinician and parents to plan about the outcome of pregnancy.
Prenatal ultrasound has been well established for decades as the primary technique for evaluating the developing fetus in normal as well as in high risk cases. Advantages of US include widespread availability, relatively low cost and quick, lack of harmful effect to fetus or mother and real time imaging.
Although ultrasound can characterize many anomalies accurately, it has many limitations as operator dependent, small field of view, and relatively poor soft-tissue contrast, beam attenuation by maternal adipose tissue and fetal bone, limited visualization of posterior fossa after 33 weeks gestation because of calvarial calcification. Also, ultrasound relies heavily on fetal positioning and presence of sufficient amniotic fluid to provide an adequate acoustic window fetus So, US findings are occasionally incomplete or inconclusive to guide treatment choices.
Fetal brain MRI became embraced as a clinically important imaging technique useful for fetal assessment, which is helpful in formulating prognosis and perinatal management and can detect occult abnormalities in up to 50% of cases for certain indications.
It can overcome many of ultrasound limitations as it is not limited by maternal obesity, fetal position, or oligohydramnios. Additionally, it has better soft tissue contrast resolution, as well as the ability to distinguish individual fetal structures such as brain, lung, liver, kidney, and bowel. In addition, visualization of the brain is not restricted by the ossified skull. Moreover, MRI provides multiplanar imaging as well a larger field of view, facilitating examination of fetuses with large or complex anomalies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant females referred from obstetric department with either suspected or detected fetal anomalies on ultrasound.
Key inclusion criteria (2 listed)
- All pregnancies with either suspected or detected fetal anomalies on ultrasound excluding first trimester pregnancies (to allow completion of period of organogenesis).
- Pregnant females with past or family history of congenital fetal abnormality.
Key exclusion criteria (4 listed)
- Pregnancies with normal antenatal US.
- pregnancies in first trimester
- Claustrophobic patients.
- contraindication to MRI as cochlear implants and pacemakers.
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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging on pregnant women after 18 weeks of pregnancy with US diagnosis of congenital CNS fetal abnormality. | Device | – |
Primary outcome
Ventricular size
Time frame: baseline
assess the ventricular size by measuring the anteroposterior diameter of the fourth ventricle, the width of the third ventricle, and the transverse diameter of the lateral ventricles on the coronal images.
1 secondary outcome
Correlate MRI findings with Ultrasound findings.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Results publication: PubMed 25120962Onkar D, Onkar P, Mitra K. Evaluation of Fetal Central Nervous System Anomalies by Ultrasound and Its Anatomical Co-relation. J Clin Diagn Res. 2014 Jun;8(6):AC05-7. doi: 10.7860/JCDR/2014/8052.4437. Epub 2014 Jun 20.
- Results publication: PubMed 28668426Manganaro L, Bernardo S, Antonelli A, Vinci V, Saldari M, Catalano C. Fetal MRI of the central nervous system: State-of-the-art. Eur J Radiol. 2017 Aug;93:273-283. doi: 10.1016/j.ejrad.2017.06.004. Epub 2017 Jun 17.
- Results publication: PubMed 27729957Sefidbakht S, Dehghani S, Safari M, Vafaei H, Kasraeian M. Fetal Central Nervous System Anomalies Detected by Magnetic Resonance Imaging: A Two-Year Experience. Iran J Pediatr. 2016 Jun 6;26(4):e4589. doi: 10.5812/ijp.4589. eCollection 2016 Aug.
- Individual participant dataSharing planned: Undecided
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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.
Nehal Mohamed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Anomalies, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Hamed (01000024182, moustafamanar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular size (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888794, which also lists 3 linked publications.
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 28 Mar 2019.