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

NCT03888794 | Unknown

• 1 other identifier: MRIUSCNS
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Anomalies

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (1)

• Correlate MRI findings with Ultrasound findings.

  baseline

Interventions

Magnetic Resonance Imaging DEVICE

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant females referred from obstetric department with either suspected or detected fetal anomalies on ultrasound.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancies with normal antenatal US.
• pregnancies in first trimester
• Claustrophobic patients.
• contraindication to MRI as cochlear implants and pacemakers.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 25120962 RESULT

• 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.

  PMID: 28668426 RESULT

• 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.

  PMID: 27729957 RESULT

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nehal Mohamed

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Hamed

CONTACT

01000024182; moustafamanar@gmail.com

Marwa Ahmed

CONTACT

01006541595; drmarwa201198@ymail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 25, 2019
• Study Start: May 20, 2019
• Primary Completion: December 30, 2020
• Study Completion: June 30, 2021
• Last Updated: March 28, 2019

Record last verified: 2019-03