Is Size of Cisterna Magna Related to the Fetal Gender and Gestational Age

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06139978
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
The Relationship Between the Anteroposterior Diameter of the CM and the Gestational Age and Gender	Behavioral: ultrasound observation

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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Is Size of Cisterna Magna Related to the Fetal Gender and Gestational Age
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women in male fetus	Behavioral: ultrasound observation; The relationship between the anteroposterior diameter of the CM and the gestational age and gender
Pregnant women in female fetus	Behavioral: ultrasound observation; The relationship between the anteroposterior diameter of the CM and the gestational age and gender

Outcome Measures

Primary Outcome Measures

1. Relation of cisterna magna size to the gender and gestational age [48 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1- Pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation.

2.Singleton pregnancy is observed without visible abnormalities.

Exclusion Criteria:

1 - .Pregnant women who are the exact gestational age can not be confirmed. 2. Fetal malformations or intrauterine growthretardation are detected. 3. Women with chronic diseases. 4. Increased bodymass index >30

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Medical School	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

• Study Chair: Elwany D Elsenousy, professor, Assiut medical school

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Gamal Abd El-Naser, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT06139978
• Other Study ID Numbers: CM.sex & age
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 18, 2023