Clinical trial NCT06311617: Retinal Vascular Changes During Pregnancy
Official title: Understanding Retinal Vascular Changes During Pregnancy and the Impact on Maternal and Fetal Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Keywords: Optical coherence tomography
Pregnancy
Imaging
Retina
Vascular
Fundus Photography
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients (healthy and those with pre-existing diabetes/hypertension, and those with pregnancy-associated hypertension and diabetes or multiple gestations)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Imaging Biomarkers: Choroid
timeFrame: during 9 months of pregnancy and in the 3 months after pregnancy
measure: Imaging Biomarkers: Vessel density
timeFrame: during 9 months of pregnancy and in the 3 months after pregnancy
measure: Imaging Biomarkers: Foveal avascular zone (FAZ)
timeFrame: during 9 months of pregnancy and in the 3 months after pregnancy
Secondary outcomes:
measure: Fetal Health: delivery
timeFrame: at time of birth
measure: Fetal Health
timeFrame: at time of birth
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Eye Institute
name: Avni P Finn, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: