Influence of Imaging Angle in Measurement of Cisterna Magna

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

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

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Fetal Cisterna Magna Length
• Intervention / Treatment: Diagnostic test: Ultrasonographic Measurement on Fetal cisterna magna length

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 Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women with low risk pregnancy between the 18th and 24th weeks with confirm gestational age who wil be referred to our prenatal diagnosis unit for ultrasonography to be performed in their second trimester.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cisterna Magna length	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cisterna Magna length according to fetal presentation	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.	24 hours
Cisterna Magna length according to fetal sex	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.	24 hours

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Investigators: Principal Investigator: Flavio Hernández-Castro, Dr. med, Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL

Publications and helpful links

General Publications

• Cho JY, Kim KW, Lee YH, Toi A. Measurement of nuchal skin fold thickness in the second trimester: influence of imaging angle and fetal presentation. Ultrasound Obstet Gynecol. 2005 Mar;25(3):253-7. doi: 10.1002/uog.1847.
• Araujo Junior E, Martins WP, Rolo LC, Pires CR, Zanforlin Filho SM. Normative data for fetal cisterna magna length measurement between 18 and 24 weeks of pregnancy. Childs Nerv Syst. 2014 Jan;30(1):9-12. doi: 10.1007/s00381-013-2298-y.
• Serhatlioglu S, Kocakoc E, Kiris A, Sapmaz E, Boztosun Y, Bozgeyik Z. Sonographic measurement of the fetal cerebellum, cisterna magna, and cavum septum pellucidum in normal fetuses in the second and third trimesters of pregnancy. J Clin Ultrasound. 2003 May;31(4):194-200. doi: 10.1002/jcu.10163.
• Liu Z, Han J, Fu F, Liu J, Li R, Yang X, Pan M, Zhen L, Li D, Liao C. Outcome of isolated enlarged cisterna magna identified in utero: experience at a single medical center in mainland China. Prenat Diagn. 2017 Jun;37(6):575-582. doi: 10.1002/pd.5046. Epub 2017 May 10.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): October 28, 2019
• Study Completion (Actual): October 28, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound; Cisterna magna length
• Other Study ID Numbers: GI19-00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No