Size of Cisterna MagnaNCT06139978
Is Size of Cisterna Magna Related to the Fetal Gender and Gestational Age
An observational study of Size of Cisterna Magna and Gestational Age and Gender Conditions, run by Assiut University at 1 site in Egypt.
Trial summary
The cisterna magna (CM) is a large subarachnoid cerebrospinal space that lies between the caudal aspect ofthe cerebellum and the medulla oblongata, drainingthe fourth ventricle . Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Size of Cisterna Magna, Gestational Age and Gender Conditions
- What is being tested?
- ultrasound observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 Dec 2024
- How long will I take part?
- 3 Months
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Prospective study that will include pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation. As in cross sectional study each fetus is considered only once. with use of magnetic resonance ultrasonography.( ultrasonography is a noninvasive imaging test uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues).
Who may be able to join
- Pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation.
- Singleton pregnancy.
Who cannot join
- .gestational age can not be confirmed.
- Fetal malformations or intrauterine growthretardation
- Women with chronic diseases.
- bodymass index >30
Trial locations and contacts
1 site in 1 country.
About this study
The cisterna magna (CM) is a large subarachnoid cerebrospinal space that lies between the caudal aspect ofthe cerebellum and the medulla oblongata, drainingthe fourth ventricle . The evaluation of the fetal cisterna magna is animportant part of obstetric ultrasound which targetsdetection of prenatal malformation of the fetal centralnervous system (CNS).Therefore, measuring the size ofthe cisterna magna has important clinical significancefor diagnosing fetal nervous system abnormalities.
Studies about the relationship between the anteroposterior diameter of the CM and the gestational age (GA) are still controversial. Some articles havepointed out that there was a good correlationbetween the diameter of the CM and GA
Read the detailed description
Prospective study that will include pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation. As in cross sectional study each fetus is considered only once. with use of magnetic resonance ultrasonography.( ultrasonography is a noninvasive imaging test uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues)
- Being tested
- ultrasound observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound observationBehavioural
The relationship between the anteroposterior diameter of the CM and the gestational age and gender
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women in male fetus | Mesurment size of cisterna magna and ather fetal biometric using 2D US Receives: Behavioral: ultrasound observation | |
| Pregnant women in female fetus | Mesurment size of cisterna magna and ather fetal biometric using 2D US Receives: Behavioral: ultrasound observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of cisterna magna size to the gender and gestational age
Mesurment of anteroposterior diameter of cisterna magna by centimeters using 2D US
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Size of Cisterna MagnaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Gamal Abd El-Naser, Assiut University
- Investigators
- Elwany D Elsenousy, professor, Study chair, Assiut medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139978
- Sponsor's protocol ID
- CM.sex & age
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McMillan JJ, Williams B. Aqueduct stenosis. Case review and discussion. J Neurol Neurosurg Psychiatry. 1977 Jun;40(6):521-32. doi: 10.1136/jnnp.40.6.521.
PubMed 302852D'Antonio F, Khalil A, Garel C, Pilu G, Rizzo G, Lerman-Sagie T, Bhide A, Thilaganathan B, Manzoli L, Papageorghiou AT. Systematic review and meta-analysis of isolated posterior fossa malformations on prenatal ultrasound imaging (part 1): nomenclature, diagnostic accuracy and associated anomalies. Ultrasound Obstet Gynecol. 2016 Jun;47(6):690-7. doi: 10.1002/uog.14900. Epub 2016 May 10.
PubMed 25970099Volpe P, Contro E, De Musso F, Ghi T, Farina A, Tempesta A, Volpe G, Rizzo N, Pilu G. Brainstem-vermis and brainstem-tentorium angles allow accurate categorization of fetal upward rotation of cerebellar vermis. Ultrasound Obstet Gynecol. 2012 Jun;39(6):632-5. doi: 10.1002/uog.11101. Epub 2012 May 14.
PubMed 22253138Araujo Junior E, Passos AP, Bruns RF, Nardozza LM, Moron AF. Reference range of fetal cisterna magna volume by three-dimensional ultrasonography using the VOCAL method. J Matern Fetal Neonatal Med. 2014 Jul;27(10):1023-8. doi: 10.3109/14767058.2013.847419. Epub 2013 Oct 22.
PubMed 24063432Araujo 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Size of Cisterna Magna Related to the Fetal Gender and Gestational Age
- ClinicalTrials.gov ID
- NCT06139978
- Acronym / sponsor ID
- CM.sex & age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 18 Nov 2023 (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 cisterna magna (CM) is a large subarachnoid cerebrospinal space that lies between the caudal aspect ofthe cerebellum and the medulla oblongata, drainingthe fourth ventricle . The evaluation of the fetal cisterna magna is animportant part of obstetric ultrasound which targetsdetection of prenatal malformation of the fetal centralnervous system (CNS).Therefore, measuring the size ofthe cisterna magna has important clinical significancefor diagnosing fetal nervous system abnormalities.
Studies about the relationship between the anteroposterior diameter of the CM and the gestational age (GA) are still controversial. Some articles havepointed out that there was a good correlationbetween the diameter of the CM and GA
Detailed description
Prospective study that will include pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation. As in cross sectional study each fetus is considered only once. with use of magnetic resonance ultrasonography.( ultrasonography is a noninvasive imaging test uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women in male fetus | – | Behavioral: ultrasound observationMesurment size of cisterna magna and ather fetal biometric using 2D US |
| Pregnant women in female fetus | – | Behavioral: ultrasound observationMesurment size of cisterna magna and ather fetal biometric using 2D US |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Prospective study that will include pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation. As in cross sectional study each fetus is considered only once. with use of magnetic resonance ultrasonography.( ultrasonography is a noninvasive imaging test uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues).
Key inclusion criteria (2 listed)
- Pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation.
- Singleton pregnancy.
Key exclusion criteria (4 listed)
- .gestational age can not be confirmed.
- Fetal malformations or intrauterine growthretardation
- Women with chronic diseases.
- bodymass index >30
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 |
|---|---|---|
| ultrasound observationThe relationship between the anteroposterior diameter of the CM and the gestational age and gender | Behavioural | Pregnant women in female fetus, Pregnant women in male fetus |
Primary outcome
Correlation of cisterna magna size to the gender and gestational age
Time frame: 48 months
Mesurment of anteroposterior diameter of cisterna magna by centimeters using 2D US
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 30 Jan 2025.
- Results publication: PubMed 302852McMillan JJ, Williams B. Aqueduct stenosis. Case review and discussion. J Neurol Neurosurg Psychiatry. 1977 Jun;40(6):521-32. doi: 10.1136/jnnp.40.6.521.
- Results publication: PubMed 25970099D'Antonio F, Khalil A, Garel C, Pilu G, Rizzo G, Lerman-Sagie T, Bhide A, Thilaganathan B, Manzoli L, Papageorghiou AT. Systematic review and meta-analysis of isolated posterior fossa malformations on prenatal ultrasound imaging (part 1): nomenclature, diagnostic accuracy and associated anomalies. Ultrasound Obstet Gynecol. 2016 Jun;47(6):690-7. doi: 10.1002/uog.14900. Epub 2016 May 10.
- Results publication: PubMed 22253138Volpe P, Contro E, De Musso F, Ghi T, Farina A, Tempesta A, Volpe G, Rizzo N, Pilu G. Brainstem-vermis and brainstem-tentorium angles allow accurate categorization of fetal upward rotation of cerebellar vermis. Ultrasound Obstet Gynecol. 2012 Jun;39(6):632-5. doi: 10.1002/uog.11101. Epub 2012 May 14.
- Results publication: PubMed 24063432Araujo Junior E, Passos AP, Bruns RF, Nardozza LM, Moron AF. Reference range of fetal cisterna magna volume by three-dimensional ultrasonography using the VOCAL method. J Matern Fetal Neonatal Med. 2014 Jul;27(10):1023-8. doi: 10.3109/14767058.2013.847419. Epub 2013 Oct 22.
- Results publication: 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.
- Individual participant dataSharing planned: Undecided
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.
Elwany D Elsenousy, professor study chair
Assiut medical school
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 Size of Cisterna Magna and Gestational Age and Gender Conditions, run by Assiut University at 1 site in Egypt.
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 4 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 30 Jan 2025. 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 Egypt. 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?
Correlation of cisterna magna size to the gender and gestational age (time frame: 48 months). 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 NCT06139978, which also lists 5 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 30 Jan 2025.