Retinal Vascular Changes During Pregnancy

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Pregnancy

Treatments: Diagnostic Test: Optical coherence tomography

Study type: Observational

Funder types: Other

Identifiers

NCT06311617

231592

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Healthy Pregnant Patients

Description:

Health pregnancies

Treatment:

Diagnostic Test: Optical coherence tomography

Pregnant Patients with Pre-Existing Diabetes

Description:

Patients with pre-existing diabetes who are pregnant

Treatment:

Diagnostic Test: Optical coherence tomography

Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease

Description:

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.

Treatment:

Diagnostic Test: Optical coherence tomography