Retinal Vascular Changes During Pregnancy

Recruiting

• Conditions: Pregnancy
• Interventions: Diagnostic Test: Fundus photography and optical coherence tomography

• Registration Number: NCT06311617
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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. 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 Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-03-02
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Patients with Pre-Existing Diabetes	Fundus photography and optical coherence tomography	Patients with pre-existing diabetes who are pregnant
Healthy Pregnant Patients	Fundus photography and optical coherence tomography	Health pregnancies
Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease	Fundus photography and optical coherence tomography	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fetal Health: delivery	at time of birth	Modality of delivery
Fetal Health	at time of birth	weight of baby at birth

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States