An Audit of the Posterior Fossa Characterization in Open Spina Bifida Based on Tertiary Center Experience

NCT03544970 | Completed

• 1 other identifier: s60814
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetal Anomaly; Spinal Dysraphism; Chiari Malformation Type 2

Keywords

fetal MRI; Posterior fossa

Outcome Measures

Primary Outcomes (1)

• (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.

  Examinations from 2011 - 2016

Eligibility Criteria

• Gender Eligibility Details: Pregnant
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fetuses with spina bifida aperta with an additiona lsubgroup of matched pairs with pre- and postoperative imaging

You may qualify if:

• 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

You may not qualify if:

• twin pregnancy, syndromal pathology, fetal hydrops or anhydramnios.
• poor image quality

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Congenital Abnormalities; Spinal Dysraphism; Arnold-Chiari Malformation

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 4, 2018
• Study Start: April 1, 2017
• Primary Completion: October 26, 2017
• Study Completion: October 31, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

BE (1)