MRI Versus Four Dimensional Ultrasound in Detection of CNS Fetal Congenital Anomalies

NCT ID: NCT03888794

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2021-06-30

Brief Summary

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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

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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

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Congenital Anomalies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Magnetic Resonance Imaging

Magnetic Resonance Imaging on pregnant women after 18 weeks of pregnancy with US diagnosis of congenital CNS fetal abnormality.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. All pregnancies with either suspected or detected fetal anomalies on ultrasound excluding first trimester pregnancies (to allow completion of period of organogenesis).
2. Pregnant females with past or family history of congenital fetal abnormality.

Exclusion Criteria

1. Pregnancies with normal antenatal US.
2. pregnancies in first trimester
3. Claustrophobic patients.
4. contraindication to MRI as cochlear implants and pacemakers.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nehal Kamal Mohamed

principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nehal Mohamed

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Ahmed Hamed

Role: CONTACT

01000024182

Marwa Ahmed

Role: CONTACT

01006541595

References

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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.

Reference Type RESULT
PMID: 25120962 (View on PubMed)

Manganaro 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.

Reference Type RESULT
PMID: 28668426 (View on PubMed)

Sefidbakht 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.

Reference Type RESULT
PMID: 27729957 (View on PubMed)

Other Identifiers

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MRIUSCNS

Identifier Type: -

Identifier Source: org_study_id

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