PregnancyNCT06311617
Retinal Vascular Changes During Pregnancy
An observational study of Pregnancy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Optical coherence tomography
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Pregnant patients (healthy and those with pre-existing diabetes/hypertension, and those with pregnancy-associated hypertension and diabetes or multiple gestations)
Who may be able to join
- Patient age 18 years and older
- Patient able to provide informed consent
- Pregnant at time of enrollment and in the 1st or 2nd trimester of pregnancy
Who cannot join
- Other ocular disease that prevents imaging (significant cataract or other media opacity)
- Unable to comply with imaging or follow-up through duration of study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Avni Finn, MD, MBA, 615-936-1639
About this study
Official title: Understanding Retinal Vascular Changes During Pregnancy and the Impact on Maternal and Fetal Health
The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. This imaging is non-invasive and does not require contact with the surface of the eye. The photos taken will allow assessment of specific parameters, like blood flow and the health of specialized cells that support vision. Understanding how the eyes change during pregnancy may help guide how retina specialists understanding of retinal disease during pregnancy and better inform pregnancy outcomes.
Read the detailed description
Pregnancy is a unique human condition marked by changes throughout the body, including changes in hormone levels, blood volume, blood pressure, and blood clot formation. These changes impact the eye as well, particularly the back part of the eye, called the retina and the choroid. Pre-existing conditions like diabetes and high blood pressure are known to affect the retina, but this impact may be increased by during pregnancy. In addition, new eye conditions may develop. The purpose of this study is to better understand how the retina and choroid changes during pregnancy.
- Conditions
- Pregnancy
- Being tested
- Optical coherence tomography
- Keywords
- Optical coherence tomography, Pregnancy, Imaging, Retina, Vascular, Fundus Photography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyDiagnostic test
Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints
| Study group | Role | What they receive |
|---|---|---|
| Healthy Pregnant Patients | Health pregnancies Receives: Diagnostic Test: Optical coherence tomography | |
| Pregnant Patients with Pre-Existing Diabetes | Patients with pre-existing diabetes who are pregnant Receives: Diagnostic Test: Optical coherence tomography | |
| Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease | 1. Multiple gestations
2. Preeclampsia or eclampsia
3. Gestational diabetes
4. Hypercoagulable state such as disseminated intravascular coagulation (DIC), thrombotic thrombocytopenic purpura (TTP), and hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome. Receives: Diagnostic Test: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging Biomarkers: Choroid
Choroidal thickness
Measured: during 9 months of pregnancy and in the 3 months after pregnancy
Imaging Biomarkers: Vessel density
Vessel density
Measured: during 9 months of pregnancy and in the 3 months after pregnancy
Imaging Biomarkers: Foveal avascular zone (FAZ)
FAZ area
Measured: during 9 months of pregnancy and in the 3 months after pregnancy
Secondary outcomes (2)
Fetal Health: delivery
Modality of delivery
Measured: at time of birth
Fetal Health
weight of baby at birth
Measured: at time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Feb 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avni Finn, Vanderbilt University Medical Center
- Investigators
- Avni P Finn, MD, MBA, Principal investigator, Vanderbilt Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311617
- Sponsor's protocol ID
- 231592
- Status last verified
- May 2026
- First submitted
- 2 Mar 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Retinal Vascular Changes During Pregnancy and the Impact on Maternal and Fetal Health
- ClinicalTrials.gov ID
- NCT06311617
- Acronym / sponsor ID
- 231592
- Conditions
- Pregnancy
- Keywords
- Optical coherence tomography, Pregnancy, Imaging, Retina, Vascular, Fundus Photography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. This imaging is non-invasive and does not require contact with the surface of the eye. The photos taken will allow assessment of specific parameters, like blood flow and the health of specialized cells that support vision. Understanding how the eyes change during pregnancy may help guide how retina specialists understanding of retinal disease during pregnancy and better inform pregnancy outcomes.
Detailed description
Pregnancy is a unique human condition marked by changes throughout the body, including changes in hormone levels, blood volume, blood pressure, and blood clot formation. These changes impact the eye as well, particularly the back part of the eye, called the retina and the choroid. Pre-existing conditions like diabetes and high blood pressure are known to affect the retina, but this impact may be increased by during pregnancy. In addition, new eye conditions may develop. The purpose of this study is to better understand how the retina and choroid changes during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Pregnant Patients | – | Diagnostic Test: Optical coherence tomographyHealth pregnancies |
| Pregnant Patients with Pre-Existing Diabetes | – | Diagnostic Test: Optical coherence tomographyPatients with pre-existing diabetes who are pregnant |
| Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease | – | Diagnostic Test: Optical coherence tomography1. Multiple gestations 2. Preeclampsia or eclampsia 3. Gestational diabetes 4. Hypercoagulable state such as disseminated intravascular coagulation (DIC), thrombotic thrombocytopenic purpura (TTP), and hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients (healthy and those with pre-existing diabetes/hypertension, and those with pregnancy-associated hypertension and diabetes or multiple gestations)
Key inclusion criteria (3 listed)
- Patient age 18 years and older
- Patient able to provide informed consent
- Pregnant at time of enrollment and in the 1st or 2nd trimester of pregnancy
Key exclusion criteria (2 listed)
- Other ocular disease that prevents imaging (significant cataract or other media opacity)
- Unable to comply with imaging or follow-up through duration of study
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 tomographyNon-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints | Diagnostic test | Healthy Pregnant Patients, Pregnant Patients with Pre-Existing Diabetes, Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease |
Primary outcome
Imaging Biomarkers: Choroid
Time frame: during 9 months of pregnancy and in the 3 months after pregnancy
Choroidal thickness
Imaging Biomarkers: Vessel density
Time frame: during 9 months of pregnancy and in the 3 months after pregnancy
Vessel density
Imaging Biomarkers: Foveal avascular zone (FAZ)
Time frame: during 9 months of pregnancy and in the 3 months after pregnancy
FAZ area
2 secondary outcomes
Fetal Health: delivery
Time frame: at time of birth
Fetal Health
Time frame: at time of birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
Avni P Finn, MD, MBA principal investigator
Vanderbilt Eye Institute
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, run by Vanderbilt University Medical Center at 1 site in United States.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saige Priddy (615-936-2020, saige.priddy@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging Biomarkers: Choroid (time frame: during 9 months of pregnancy and in the 3 months after pregnancy). 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 May 2026.