Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation

NCT05717855 — Not applicable, Completed, 52 participants, Gaziosmanpasa Research and Education Hospital

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Registry	NCT05717855
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	52 (Actual)
Sponsor	Gaziosmanpasa Research and Education Hospital (Other gov)
Conditions	2D Ultrasound, Cavum Septum Pellucidum, Septooptic Dysplasia, Optic Chiasma, Willis Polygon
Interventions	Displaying optic chiasm for screening septooptic dysplasia (Diagnostic test)
Dates	start 2020-09-21, primary completion 2021-03-21, completion 2021-04-21, first posted 2023-02-08, last updated 2023-02-08
Locations	1 site in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Screening septooptic dysplasia	Other	Diagnostic Test: Displaying optic chiasm for screening septooptic dysplasia	Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia

Displaying optic chiasm for screening septooptic dysplasia (Diagnostic test), also known as Measuring the width and length of the optic chiasm for screening septooptic dysplasia: Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia with ultrasound between 16-20 weeks of gestation

+Outcome measures

Primary outcomes

Calculation of average width of OC according to gestational week in millimeter [2 months]
Calculation of average height of OC according to gestational week in millimeter [2 months]
Calculation of average area of OC according to gestational week millimeter square [2 months]

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Gaziosmanpasa Training and Research Hospital	Istanbul	Turkey (Türkiye)