Clinical trial NCT06139978: Is Size of Cisterna Magna Related to the Fetal Gender and Gestational Age
Official title: Is Size of Cisterna Magna Related to the Fetal Gender and Gestational Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Size of Cisterna Magna
Gestational Age and Gender Conditions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 450
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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 . 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)

Eligibility criteria: Inclusion Criteria:

* Pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation.
* Singleton pregnancy.

Exclusion Criteria:

.gestational age can not be confirmed.

* Fetal malformations or intrauterine growthretardation
* Women with chronic diseases.
* bodymass index \>30

Primary outcomes:
measure: Correlation of cisterna magna size to the gender and gestational age
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Medical School
Study officials:
affiliation: Assiut medical school
name: Elwany D Elsenousy, professor
role: STUDY_CHAIR
References:
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citation: D'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.
citation: Volpe 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.
citation: Araujo 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.
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.