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

• Conditions: Congenital Anomalies

• Registration Number: NCT03888794
• Lead Sponsor: Assiut University

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.

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-28
• Study Start: 2019-05-20
• Primary Completion: 2020-12-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Correlate MRI findings with Ultrasound findings.	baseline	to correlate fetal biometry and ventricular size with ultrasound findings.