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

NCT ID: NCT05717855

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-04-21

Brief Summary

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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

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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.

Conditions

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2D Ultrasound Cavum Septum Pellucidum Septooptic Dysplasia Optic Chiasma Willis Polygon

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Screening septooptic dysplasia

Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia

Group Type OTHER

Displaying optic chiasm for screening septooptic dysplasia

Intervention Type DIAGNOSTIC_TEST

Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia with ultrasound between 16-20 weeks of gestation

Interventions

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Displaying 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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Measuring the width and length of the optic chiasm for screening septooptic dysplasia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Süleyman Salman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gaziosmanpasa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GaziosmanpaşaTREHu

Identifier Type: -

Identifier Source: org_study_id

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