Influence of Imaging Angle in Measurement of Cisterna Magna

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Completed
CT.gov ID
NCT03697902
Collaborator
(none)
94
1
12.4
7.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
94 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Influence of Imaging Angle in Measurement of Cisterna Magna in the Second Trimester
Actual Study Start Date :
Oct 15, 2018
Actual Primary Completion Date :
Oct 28, 2019
Actual Study Completion Date :
Oct 28, 2019

Outcome Measures

Primary Outcome Measures

  1. Cisterna Magna length [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.

Secondary Outcome Measures

  1. Cisterna Magna length according to fetal presentation [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.

  2. Cisterna Magna length according to fetal sex [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Dr. José Eleuterio González Monterrey Nuevo León Mexico 64460

Sponsors and Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. med Flavio Hernández Castro, Principal investigator MD PhD Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT03697902
Other Study ID Numbers:
  • GI19-00010
First Posted:
Oct 5, 2018
Last Update Posted:
Dec 2, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. med Flavio Hernández Castro, Principal investigator MD PhD Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez

Study Results

No Results Posted as of Dec 2, 2019