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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03888794
Collaborator
(none)
50
25.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Magnetic Resonance Imaging

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

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Magnetic Resonance Imaging Versus Four Dimensional Ultrasound in Detection of Central Nervous System Fetal Congenital Anomalies
Anticipated Study Start Date :
May 20, 2019
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Jun 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Ventricular size [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.

Secondary Outcome Measures

  1. Correlate MRI findings with Ultrasound findings. [baseline]

    to correlate fetal biometry and ventricular size with ultrasound findings.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Nehal Mohamed, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nehal Kamal Mohamed, principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03888794
Other Study ID Numbers:
  • MRIUSCNS
First Posted:
Mar 25, 2019
Last Update Posted:
Mar 28, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2019