Viewing Study NCT03697902


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Study NCT ID: NCT03697902
Status: COMPLETED
Last Update Posted: 2019-12-02
First Post: 2018-10-04
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Influence of Imaging Angle in Measurement of Cisterna Magna
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Organization:

Study Overview

Official Title: Influence of Imaging Angle in Measurement of Cisterna Magna in the Second Trimester
Status: COMPLETED
Status Verified Date: 2019-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this study is to determine the effect of imaging angle on the measurement of fetal cisterna magna (CM) in the second trimester.

Fetal CM will be prospectively measured in women at 18-24.6 weeks' gestation. Measurements will be made on different angles between the transducer and fetal cerebellar axial plane with internal landmarks.

Design: Observative, cross sectional
Detailed Description: Patients and methods: women with low risk single pregnancy will be studied. Fetuses with multiple pregnancies, maternal chronic disease and severe congenital anomalies except mega cisterna magna (MCM) will be excluded from the study. Measurements will be performed on the axial cerebellar plane.The anteroposterior measurement will be made between the posterior border of the cerebellar vermis and the internal face of the occipital bone.

The primary outcome variables will be cisterna magna length measured on different angles between the transducer and the axial cerebellar plane of the fetal head.

Cisterna magna length measurement related to fetal presentation and gender will be secondary outcomes.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: