Retinal Vascular Changes During Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311617
• Other study ID #: 231592
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: January 2027

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Marybeth Carter
• Phone: 615-936-2020
• Email: marybeth.l.carter[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Diagnostic Test:
• Fundus photography and optical coherence tomography
Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging Biomarkers: Choroid	Choroidal thickness	during 9 months of pregnancy and in the 3 months after pregnancy
Primary	Imaging Biomarkers: Vessel density	Vessel density	during 9 months of pregnancy and in the 3 months after pregnancy
Primary	Imaging Biomarkers: Foveal avascular zone (FAZ)	FAZ area	during 9 months of pregnancy and in the 3 months after pregnancy
Secondary	Fetal Health: delivery	Modality of delivery	at time of birth
Secondary	Fetal Health	weight of baby at birth	at time of birth