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Completed

NCT Number: NCT05717855

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

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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Key information

Conditions

2D Ultrasound Agenesis of Corpus Callosum Cavum Septum Pellucidum Congenital Abnormalities Congenital Cranial Dysinnervation Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Eye Diseases Nervous System Diseases Nervous System Malformations Ocular Motility Disorders Oculomotor Nerve Diseases Optic Chiasma Optic Nerve Hypoplasia Septo-Optic Dysplasia Septooptic Dysplasia Willis Polygon

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Displaying optic chiasm for screening septooptic dysplasia

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

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

Primary outcomes

  1. Calculation of average width of OC according to gestational week in millimeter

    Time frame: 2 months

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

    Time frame: 2 months

  3. Calculation of average area of OC according to gestational week millimeter square

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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