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CompletedNCT03697902Updated Dec 2, 2019

Influence of Imaging Angle in Measurement of Cisterna Magna

An observational study in Fetal Cisterna Magna Length and Ultrasonography, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
94
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Fetal Cisterna Magna Length
  • Ultrasonography

Keywords

  • Cisterna magna length
  • ultrasound
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In context

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
94 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testUltrasonographic 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

Secondary outcomes

  1. 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.

    Time frame: 24 hours

  2. 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.

    Time frame: 24 hours

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Study locations

1 site
  • Hospital Universitario Dr. José Eleuterio González
    Monterrey, Nuevo León 64460, Mexico
08

References and documents

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. PubMed 15736211 ↗
  • 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. PubMed 24122018 ↗
  • 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. PubMed 12692827 ↗
  • 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. PubMed 28370151 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03697902
Lead sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Responsible party
Dr. med Flavio Hernández Castro (Principal investigator MD PhD Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez) — Principal investigator
First posted
Oct 5, 2018
Start date
Oct 15, 2018
Primary completion
Oct 28, 2019
Completion
Oct 28, 2019
Last update
Dec 2, 2019

Study contacts

Flavio Hernández-Castro, Dr. med
principal investigator · Hospital Universitario Dr. José Eleuterio González UANL

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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