Retinal Vascular Changes During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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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

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Pregnant Patients

Health pregnancies

Optical coherence tomography

Intervention Type DIAGNOSTIC_TEST

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

Optical coherence tomography

Intervention Type DIAGNOSTIC_TEST

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

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.

Optical coherence tomography

Intervention Type DIAGNOSTIC_TEST

Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints

Interventions

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Optical coherence tomography

Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No