Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
Primary Purpose
2D Ultrasound, Cavum Septum Pellucidum, Septooptic Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Displaying optic chiasm for screening septooptic dysplasia
Sponsored by
About this trial
This is an interventional diagnostic trial for 2D Ultrasound
Eligibility Criteria
Inclusion Criteria: aged greater than 18 years old having singleton pregnancy Exclusion Criteria: being under the age of 18 having IVF pregnancy having multiple pregnancy comorbidity during pregnancy smoking history presence of familial genetic disease
Sites / Locations
- Gaziosmanpasa Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Screening septooptic dysplasia
Arm Description
Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia
Outcomes
Primary Outcome Measures
Calculation of average width of OC according to gestational week in millimeter
Calculation of average height of OC according to gestational week in millimeter
Calculation of average area of OC according to gestational week millimeter square
Secondary Outcome Measures
Full Information
NCT ID
NCT05717855
First Posted
January 25, 2023
Last Updated
February 5, 2023
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05717855
Brief Title
Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
Official Title
Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
March 21, 2021 (Actual)
Study Completion Date
April 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of prenatal optic chiasm (OC) is important for the differential diagnosis of septo-optic dysplasia (SOD), which is a congenital optic disc anomaly, and the absence of the cavum septum pellucidum (CSP). Septo-optic dysplasia is associated with a wide range of neurological abnormalities, including hypoplasia of the visual pathways, CSP agenesis, and developmental delay.
Detailed Description
Up to now, optic chiasm measurement were all done in the third trimester. in the present study, OC will be measure directly in a 2D ultrasound in coronal plane within the second trimester. In fetuses with SP agenesis, the morphology and width of the OC visual pathway may be a suitable tool to assess its development. It can also assist in the difficult task of providing prenatal counseling when faced with a diagnosis of CP agenesis. therefore In the present study, it was planned to show the optic chiasm in the screening of septooptic dysplasia by ultrasound between 16-20 weeks of gestation, and to measure the optic chiasma width and length, and to determine the mean values in the second trimester.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2D Ultrasound, Cavum Septum Pellucidum, Septooptic Dysplasia, Optic Chiasma, Willis Polygon
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening septooptic dysplasia
Arm Type
Other
Arm Description
Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia
Intervention Type
Diagnostic Test
Intervention Name(s)
Displaying optic chiasm for screening septooptic dysplasia
Other Intervention Name(s)
Measuring the width and length of the optic chiasm for screening septooptic dysplasia
Intervention Description
Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia with ultrasound between 16-20 weeks of gestation
Primary Outcome Measure Information:
Title
Calculation of average width of OC according to gestational week in millimeter
Time Frame
2 months
Title
Calculation of average height of OC according to gestational week in millimeter
Time Frame
2 months
Title
Calculation of average area of OC according to gestational week millimeter square
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged greater than 18 years old
having singleton pregnancy
Exclusion Criteria:
being under the age of 18
having IVF pregnancy
having multiple pregnancy
comorbidity during pregnancy
smoking history
presence of familial genetic disease
Facility Information:
Facility Name
Gaziosmanpasa Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
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