Retinal Vascular Changes During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optical coherence tomography.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Understanding Retinal Vascular Changes During Pregnancy and the Impact on Maternal and Fetal Health
Overview
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.
Interventions
- Diagnostic test Optical coherence tomography
Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints
Primary outcome measures
- Imaging Biomarkers: Choroid [Time frame: during 9 months of pregnancy and in the 3 months after pregnancy]
- Imaging Biomarkers: Vessel density [Time frame: during 9 months of pregnancy and in the 3 months after pregnancy]
- Imaging Biomarkers: Foveal avascular zone (FAZ) [Time frame: during 9 months of pregnancy and in the 3 months after pregnancy]
Secondary outcome measures (2)
- Fetal Health: delivery [Time frame: at time of birth]
- Fetal Health [Time frame: at time of birth]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Other ocular disease that prevents imaging (significant cataract or other media opacity)
- Unable to comply with imaging or follow-up through duration of study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT06311617 · 231592