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

Not Applicable

Completed

• Conditions: 2D Ultrasound; Cavum Septum Pellucidum; Optic Chiasma; Septooptic Dysplasia; Willis Polygon
• Interventions: Diagnostic Test: Displaying optic chiasm for screening septooptic dysplasia

• Registration Number: NCT05717855
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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.

Study Timeline

• Study Start: 2020-09-21
• Primary Completion: 2021-03-21
• Study Completion: 2021-04-21
• Study First Submitted: 2023-01-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-05
• Last Update Submitted: 2023-02-05
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening septooptic dysplasia	Displaying optic chiasm for screening septooptic dysplasia	Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gaziosmanpasa Training and Research Hospital; 🇹🇷 Istanbul, Turkey