Retinal Vascular Changes During Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Diagnostic test: Optical coherence tomography

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 Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Elise Timtim, MD; Phone Number: 615-936-2020; Email: elise.timtim@vumc.org
• Study Contact Backup: Name: Saige Priddy; Phone Number: 615-936-2020; Email: saige.priddy@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Avni Finn, MD, MBA; Phone Number: 615-936-1639

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients (healthy and those with pre-existing diabetes/hypertension, and those with pregnancy-associated hypertension and diabetes or multiple gestations)

Description

Inclusion Criteria:

1. Patient age 18 years and older
2. Patient able to provide informed consent
3. Pregnant at time of enrollment and in the 1st or 2nd trimester of pregnancy

Exclusion Criteria:

1. Other ocular disease that prevents imaging (significant cataract or other media opacity)
2. Unable to comply with imaging or follow-up through duration of study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Pregnant Patients; Health pregnancies	Diagnostic test: Optical coherence tomography; Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints
Pregnant Patients with Pre-Existing Diabetes; Patients with pre-existing diabetes who are pregnant	Diagnostic test: Optical coherence tomography; Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints
Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease; Multiple gestations; Preeclampsia or eclampsia; Gestational diabetes; Hypercoagulable state such as disseminated intravascular coagulation (DIC), thrombotic thrombocytopenic purpura (TTP), and hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome.	Diagnostic test: Optical coherence tomography; Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging Biomarkers: Choroid	Choroidal thickness	during 9 months of pregnancy and in the 3 months after pregnancy
Imaging Biomarkers: Vessel density	Vessel density	during 9 months of pregnancy and in the 3 months after pregnancy
Imaging Biomarkers: Foveal avascular zone (FAZ)	FAZ area	during 9 months of pregnancy and in the 3 months after pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Health: delivery	Modality of delivery	at time of birth
Fetal Health	weight of baby at birth	at time of birth

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Avni P Finn, MD, MBA, Vanderbilt Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 2, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Imaging; Retina; Optical coherence tomography; Pregnancy; Vascular; Fundus Photography
• Additional Relevant MeSH Terms: Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID Numbers: 231592

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No