2D UltrasoundNCT05717855
Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
A study testing Displaying optic chiasm for screening septooptic dysplasia in people with 2D Ultrasound and Cavum Septum Pellucidum, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- 2D Ultrasound, Cavum Septum Pellucidum, Septooptic Dysplasia
- What is being tested?
- Displaying optic chiasm for screening septooptic dysplasia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2020to 21 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged greater than 18 years old
- having singleton pregnancy
Who cannot join
- being under the age of 18
- having IVF pregnancy
- having multiple pregnancy
- comorbidity during pregnancy
- smoking history
- presence of familial genetic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
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.
Read the 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.
- Conditions
- 2D Ultrasound, Cavum Septum Pellucidum, Septooptic Dysplasia, Optic Chiasma, Willis Polygon
- Being tested
- Displaying optic chiasm for screening septooptic dysplasia
- Medical subject headings
- Septo-Optic Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Displaying optic chiasm for screening septooptic dysplasiaDiagnostic test
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Screening septooptic dysplasia | Other | Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia Receives: Diagnostic Test: Displaying optic chiasm for screening septooptic dysplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of average width of OC according to gestational week in millimeter
Measured: 2 months
Calculation of average height of OC according to gestational week in millimeter
Measured: 2 months
Calculation of average area of OC according to gestational week millimeter square
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start21 Sep 2020
- Primary completion21 Mar 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2D UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Süleyman Salman, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717855
- Sponsor's protocol ID
- GaziosmanpaşaTREHu
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT05717855
- Acronym / sponsor ID
- GaziosmanpaşaTREHu
- Conditions
- 2D Ultrasound, Cavum Septum Pellucidum, Septooptic Dysplasia, Optic Chiasma, Willis Polygon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening septooptic dysplasia | Other | Diagnostic Test: Displaying optic chiasm for screening septooptic dysplasiaDisplaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged greater than 18 years old
- having singleton pregnancy
Key exclusion criteria (6 listed)
- being under the age of 18
- having IVF pregnancy
- having multiple pregnancy
- comorbidity during pregnancy
- smoking history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Displaying optic chiasm for screening septooptic dysplasiaAlso: Measuring the width and length of the optic chiasm for screening septooptic dysplasiaDisplaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia with ultrasound between 16-20 weeks of gestation | Diagnostic test | Screening septooptic dysplasia |
Primary outcome
Calculation of average width of OC according to gestational week in millimeter
Time frame: 2 months
Calculation of average height of OC according to gestational week in millimeter
Time frame: 2 months
Calculation of average area of OC according to gestational week millimeter square
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Displaying optic chiasm for screening septooptic dysplasia in people with 2D Ultrasound and Cavum Septum Pellucidum, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of average width of OC according to gestational week in millimeter (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.