Fetal Cisterna Magna LengthNCT03697902
Influence of Imaging Angle in Measurement of Cisterna Magna
An observational study of Fetal Cisterna Magna Length and Ultrasonography, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Cisterna Magna Length, Ultrasonography
- What is being tested?
- Ultrasonographic Measurement on Fetal cisterna magna length
- How many people
- 94 participants
- Where
- 1 siteMexico
- Study dates
- 15 Oct 2018to 28 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 64460
About this study
Official title: 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
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.
- Conditions
- Fetal Cisterna Magna Length, Ultrasonography
- Being tested
- Ultrasonographic Measurement on Fetal cisterna magna length
- Keywords
- Cisterna magna length, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic Measurement on Fetal cisterna magna lengthDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start15 Oct 2018
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fetal Cisterna Magna LengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Flavio Hernández-Castro, Dr. med, Principal investigator, Hospital Universitario Dr. José Eleuterio González UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697902
- Sponsor's protocol ID
- GI19-00010
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2018
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15736211Araujo 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 24122018Serhatlioglu 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 12692827Liu 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Imaging Angle in Measurement of Cisterna Magna in the Second Trimester
- ClinicalTrials.gov ID
- NCT03697902
- Acronym / sponsor ID
- GI19-00010
- Conditions
- Fetal Cisterna Magna Length, Ultrasonography
- Keywords
- Cisterna magna length, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic Measurement on Fetal cisterna magna lengthThe 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. | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
Cisterna Magna length according to fetal presentation
Time frame: 24 hours
Cisterna Magna length according to fetal sex
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Background: PubMed 15736211Cho 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.
- Background: PubMed 24122018Araujo 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.
- Background: PubMed 12692827Serhatlioglu 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.
- Background: PubMed 28370151Liu 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio Hernández-Castro, Dr. med principal investigator
Hospital Universitario Dr. José Eleuterio González UANL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Cisterna Magna Length and Ultrasonography, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cisterna Magna length (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03697902, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.