Retinal Vascular Changes During Pregnancy

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06311617
Status
Recruiting
Apply to this trial

Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Optical coherence tomography — DIAGNOSTIC_TEST
    Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Healthy Pregnant Patients
    Health pregnancies
  • Arm: Pregnant Patients with Pre-Existing Diabetes
    Patients with pre-existing diabetes who are pregnant
  • Arm: 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.

Primary Outcome Measure

Imaging Biomarkers: Choroid [ Time Frame: during 9 months of pregnancy and in the 3 months after pregnancy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Avni Finn, MD, MBA
615-936-1639

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By research site
Vanderbilt University Medical Center· Nashville, TN

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