Clinical trial NCT03697902: Influence of Imaging Angle in Measurement of Cisterna Magna
Official title: Influence of Imaging Angle in Measurement of Cisterna Magna in the Second Trimester
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Cisterna Magna Length
Ultrasonography
Keywords: Cisterna magna length
ultrasound
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 94
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cisterna Magna length
timeFrame: 24 hours
Secondary outcomes:
measure: Cisterna Magna length according to fetal presentation
timeFrame: 24 hours
measure: Cisterna Magna length according to fetal sex
timeFrame: 24 hours
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo León
Study officials:
affiliation: Hospital Universitario Dr. José Eleuterio González UANL
name: Flavio Hernández-Castro, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.