Congenital Anomalies Clinical Trial
Official title:
Magnetic Resonance Imaging Versus Four Dimensional Ultrasound in Detection of Central Nervous System Fetal Congenital Anomalies
Verified date | March 2019 |
Source | Assiut University |
Contact | Ahmed Hamed |
Phone | 01000024182 |
moustafamanar[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2021 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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. Review. — View Citation
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. — View Citation
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. eCollection 2016 Aug. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Correlate MRI findings with Ultrasound findings. | to correlate fetal biometry and ventricular size with ultrasound findings. | baseline |
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