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

Sponsor
Gaziosmanpasa Research and Education Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05717855
Collaborator
(none)
52
Enrollment
1
Location
1
Arm
7
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Displaying optic chiasm for screening septooptic dysplasia
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
Actual Study Start Date :
Sep 21, 2020
Actual Primary Completion Date :
Mar 21, 2021
Actual Study Completion Date :
Apr 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Screening septooptic dysplasia

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

Diagnostic Test: 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
Other Names:
  • Measuring the width and length of the optic chiasm for screening septooptic dysplasia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Calculation of average width of OC according to gestational week in millimeter [2 months]

    2. Calculation of average height of OC according to gestational week in millimeter [2 months]

    3. Calculation of average area of OC according to gestational week millimeter square [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gaziosmanpasa Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Gaziosmanpasa Research and Education Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Süleyman Salman, Associate Professor, Gaziosmanpasa Research and Education Hospital
    ClinicalTrials.gov Identifier:
    NCT05717855
    Other Study ID Numbers:
    • GaziosmanpaşaTREHu
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Septo-Optic Dysplasia

    Study Results

    No Results Posted as of Feb 8, 2023