Fetal Anomaly Clinical Trial
Official title:
An Audit of the Posterior Fossa Characterization in Open Spina Bifida Based on Tertiary Center Experience
NCT number | NCT03544970 |
Other study ID # | s60814 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2017 |
Est. completion date | October 31, 2018 |
Verified date | December 2018 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Brain stem and posterior fossa measurements in spina bifida aperta fetuses to compare them with normal population. Additionally, Describe the difference between pre- and postoperative findings.
Status | Completed |
Enrollment | 316 |
Est. completion date | October 31, 2018 |
Est. primary completion date | October 26, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - patients were those having fetal MR examination for additional assessment because of the prenatal diagnosis of SBA on ultrasound. - appropriate gestational age - matched controls. The latter were fetuses assessed for other congenital anomalies, which do not affect the central nervous system (CNS) or were scanned for suspected CNS abnormalities with normal prenatal US, fetal MR and normal postnatal evaluation Exclusion Criteria: - twin pregnancy, syndromal pathology, fetal hydrops or anhydramnios. - poor image quality |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | (1) assess the reliability of brain stem and posterior fossa measurements and compare the reliable ones with a normal populations (2) and between paired pre- and postsurgical fetuses | Biometric variables include the transverse cerebellar diameter (TCD), Transverse diameter of the fossa posterior (TDPF), the midsagittal PF area. The ventricular width will be measured in the coronal plane according to Garel and in case of asymmetry the largest value will be taken into account. Mammilopontine distande (MPD), the level of kinking of the brain stem, medullary length, tentorial length and width of the cisterna magna will be measured. The width of the foramen magnum is defined as the distance between opisthion to the basion. Tonsillar level (TL) will be measured by drawing a perpendicular line from the foramen magnum to the lowest cerebellar portion. In the presence of cerebellar herniation the deepest portion will be used. The cerebellopontine angle will also be measured. These are all metric data and will be reported in mm. To adjust for normal changes according to gestational age, there will be a correction based on an observed/expeted ratio for the parameters. |
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