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NCT Number: NCT06311617

Retinal Vascular Changes During Pregnancy

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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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Avni Finn, MD, MBA

CONTACT

615-936-1639

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical coherence tomography

Diagnostic Test

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

Primary outcomes

  1. Imaging Biomarkers: Choroid

    Time frame: during 9 months of pregnancy and in the 3 months after pregnancy

    Choroidal thickness

  2. Imaging Biomarkers: Vessel density

    Time frame: during 9 months of pregnancy and in the 3 months after pregnancy

    Vessel density

  3. Imaging Biomarkers: Foveal avascular zone (FAZ)

    Time frame: during 9 months of pregnancy and in the 3 months after pregnancy

    FAZ area

Secondary outcomes

  1. Fetal Health: delivery

    Time frame: at time of birth

    Modality of delivery

  2. Fetal Health

    Time frame: at time of birth

    weight of baby at birth

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Timtim, MD

CONTACT

[email protected]

615-936-2020

Saige Priddy

CONTACT

[email protected]

615-936-2020

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Understanding Retinal Vascular Changes During Pregnancy and the Impact on Maternal and Fetal Health

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 15, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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