Influence of Imaging Angle in Measurement of Cisterna Magna

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Flavio Hernández Castro，Hospital Universitario Dr. Jose E. Gonzalez

Tracking Information

First Submitted Date ^ICMJE

October 4, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

October 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cisterna Magna length[ Time Frame: 24 hours ]

The length measurement on the CM with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Measurements of the anteroposterior diameter Will be obtained along straight lines between the posterior border of the cerebellar vermis and the internal face of the occipital bone.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Cisterna Magna length according to fetal presentation[ Time Frame: 24 hours ]
The length measurement on the CM with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Measurements will be made in fetuses with cephalic and breech presentation. Another measurement will be made in fetuses with cephalic presentation that had converted to breech presentation or viceversa in less than 24 hours.
Cisterna Magna length according to fetal sex[ Time Frame: 24 hours ]
The length measurement on the cisterna magna (CM) with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Those measurements will be compare between male and female fetuses.

Descriptive Information

Brief Title ^ICMJE

Influence of Imaging Angle in Measurement of Cisterna Magna

Official Title ^ICMJE

Influence of Imaging Angle in Measurement of Cisterna Magna in the Second Trimester

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: 94 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 Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Diagnostic Test: Ultrasonographic Measurement on Fetal cisterna magna length
The length measurement on the fetal cisterna magna (CM) with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Measurements will be performed on the axial cerebellar plane using internal landmarks including the cavum septi pellucidi, thalamus, third ventricle, cerebral peduncles and cerebellar hemispheres.The anteroposterior measurement will be made between the posterior border of the cerebellar vermis and the internal face of the occipital bone. All the ultrasonography examinations were performed abdominally, using 3-5 megahertz (MHz) transducers.

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 15, 2019

Estimated Primary Completion Date

October 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Pregnant women between the 18th and 24th weeks. - Confirmed gestational age by regular menstrual cycle or determined from crown- rump length at first trimester ultrasonography for those with unknown menstruation date . Exclusion Criteria: - Uncertain gestational age - Twin or multiple pregnancy. - Increased risk for aneuploidy determined by first trimester screening. - Absence of intracranial translucency in first trimester ultrasound examination. - Fetal malformations identified EXCEPT megacisterna magna. - Karyotype anomaly. - Chronic maternal diseases such as arterial hypertension, diabetes mellitus, hypothyroidism and hyperthyroidism. - Failure to obtain accurate measurement for technical reasons.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Mexico

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Flavio Hernández Castro，Hospital Universitario Dr. Jose E. Gonzalez

Study Sponsor ^ICMJE

Hospital Universitario Dr. Jose E. Gonzalez

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Flavio Hernández-Castro, Dr. med Hospital Universitario Dr. José Eleuterio González UANL

PRS Account

Hospital Universitario Dr. Jose E. Gonzalez

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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