Pregnancy RelatedNCT04950855
Retinal and Choroidal Microvascular Changes During Pregnancy Period Detected With Optical Coherence Tomography Angiography
An observational study of Pregnancy Related, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
During pregnancy many physiological changes and adaptations occur.Hormonal, hematological and hemodynamic changes are responsible for most of the ocular adaptations.We are planning to compare the choroid and retinal blood flow values and choroidal thickness of pregnant women and healthy non pregnant women with optical… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2021to 1 Nov 2021
- Phase
- Observational
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Retinal and choroid thickness and retinal angiographic values will be measured in healthy pregnant population (1 time for each trimester,totally 3 times) and healty control group
Who may be able to join
- Healthy pregnant women Age > 18 years
Who cannot join
- Systemical disease such as diabetes mellitus or hypertension
- Refractive error; spherical equivalence > 4 diopters
- Ocular disease or surgery history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Retinal and Choroidal Microvascular Structures: Comparison With Three Trimesters of Healthy Pregnant Women and Healthy Non-pregnant Women Using Optical Coherence Tomography Angiography
During pregnancy many physiological changes and adaptations occur.Hormonal, hematological and hemodynamic changes are responsible for most of the ocular adaptations.We are planning to compare the choroid and retinal blood flow values and choroidal thickness of pregnant women and healthy non pregnant women with optical coherence tomography and optic coherence tomography angiography
Read the detailed description
During pregnancy many physiological changes and adaptations occur such as pulmonary, renal, endocrinological, haematological and visual system changes are happening. In previous studies, retinal and choroidal pregnancy-related changes in blood flow and choroidal thickness have been demonstrated. Optical coherence tomography angiography (OCTA) detects the contrast of motion in the blood flow, detecting the capillary of the retina and choroid.
It is a new functional method that visualizes the retinal networks and outer retina without using dyes.It is a non-invasive method that provides volumetric angiography information. In this study evaluation of the variability of choroidal and retinal blood flow changes and choroidal thickness, between trimesters of pregnancy and the non-pregnant control group is planned. Choroid and Retinal Blood Flow Values and Choroidal thickness in 41 pregnant women in the first trimester and it would be repeated at second and third trimesters. We compare measured values between trimesters and 45 healthy non-pregnant women.
- Conditions
- Pregnancy Related
- Being tested
- Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)
- Keywords
- Pregnancy, Tomography, Optical Coherence, Choroid, retina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)Diagnostic test
Also called Pachymetry, Otorefractometry, Tonometry, Blood Pressure Measurement
Optical coherence tomography optical coherence tomography angiography
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Healty pregnant women between 18-45 years,with no history of eye surgery and systemical disease.In 1st , 2nd and 3rd trimesters the measurements will be repeated Receives: Diagnostic Test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon) | |
| Control Group | Healty non-pregnant women between 18-45 years with no history of eye surgery and systemical disease. Receives: Diagnostic Test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Choroidal thickness is measured by optical coherence tomography
Measured: 40 weeks
Retinal thickness
Retinal thickness is measured by optical coherence tomography
Measured: 40 weeks
Secondary outcomes (4)
Foveal avascular zone(FAZ) area measurement
FAZ area is measured by optical coherence tomography anjiography
Measured: 40 weeks
Retinal vascular density
% of retinal vascular density is measured by optical coherence tomography angiography
Measured: 40 weeks
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography
Measured: 40 weeks
Ganglion cell layer measurement
Ganglion cell layer measurement is measured by optical coherence tomography
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start26 Jun 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Why it stopped: Due to the difficulty in following pregnant women due to the covid 19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çisil Erkan Pota, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950855
- Sponsor's protocol ID
- Study1
- Status last verified
- Nov 2021
- First submitted
- 24 Jun 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retinal and Choroidal Microvascular Structures: Comparison With Three Trimesters of Healthy Pregnant Women and Healthy Non-pregnant Women Using Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04950855
- Acronym / sponsor ID
- Study1
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Tomography, Optical Coherence, Choroid, retina
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the difficulty in following pregnant women due to the covid 19 pandemic
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 6 Jul 2021 (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.
During pregnancy many physiological changes and adaptations occur.Hormonal, hematological and hemodynamic changes are responsible for most of the ocular adaptations.We are planning to compare the choroid and retinal blood flow values and choroidal thickness of pregnant women and healthy non pregnant women with optical coherence tomography and optic coherence tomography angiography
Detailed description
During pregnancy many physiological changes and adaptations occur such as pulmonary, renal, endocrinological, haematological and visual system changes are happening. In previous studies, retinal and choroidal pregnancy-related changes in blood flow and choroidal thickness have been demonstrated. Optical coherence tomography angiography (OCTA) detects the contrast of motion in the blood flow, detecting the capillary of the retina and choroid.
It is a new functional method that visualizes the retinal networks and outer retina without using dyes.It is a non-invasive method that provides volumetric angiography information. In this study evaluation of the variability of choroidal and retinal blood flow changes and choroidal thickness, between trimesters of pregnancy and the non-pregnant control group is planned. Choroid and Retinal Blood Flow Values and Choroidal thickness in 41 pregnant women in the first trimester and it would be repeated at second and third trimesters. We compare measured values between trimesters and 45 healthy non-pregnant women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Diagnostic Test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)Healty pregnant women between 18-45 years,with no history of eye surgery and systemical disease.In 1st , 2nd and 3rd trimesters the measurements will be repeated |
| Control Group | – | Diagnostic Test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)Healty non-pregnant women between 18-45 years with no history of eye surgery and systemical disease. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Retinal and choroid thickness and retinal angiographic values will be measured in healthy pregnant population (1 time for each trimester,totally 3 times) and healty control group
Key inclusion criteria (1 listed)
- Healthy pregnant women Age > 18 years
Key exclusion criteria (3 listed)
- Systemical disease such as diabetes mellitus or hypertension
- Refractive error; spherical equivalence > 4 diopters
- Ocular disease or surgery 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 |
|---|---|---|
| Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)Also: Pachymetry, Otorefractometry, Tonometry, Blood Pressure MeasurementOptical coherence tomography optical coherence tomography angiography | Diagnostic test | Control Group, Pregnant Women |
Primary outcome
Choroidal thickness
Time frame: 40 weeks
Choroidal thickness is measured by optical coherence tomography
Retinal thickness
Time frame: 40 weeks
Retinal thickness is measured by optical coherence tomography
4 secondary outcomes
Foveal avascular zone(FAZ) area measurement
Time frame: 40 weeks
Retinal vascular density
Time frame: 40 weeks
Retinal nerve fiber layer thickness
Time frame: 40 weeks
Ganglion cell layer measurement
Time frame: 40 weeks
Results and safety
The study was stopped early (reason given: Due to the difficulty in following pregnant women due to the covid 19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Yes
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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?
An observational study of Pregnancy Related, run by Akdeniz University 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Nov 2021. 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 was stopped early (reason given: Due to the difficulty in following pregnant women due to the covid 19 pandemic). Results are not available in the source record.
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?
Choroidal thickness (time frame: 40 weeks). The study lists 2 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 2 Nov 2021.