An observational study in Pregnancy, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Vanderbilt University Medical Center · Observational
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.
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.
Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant patients (healthy and those with pre-existing diabetes/hypertension, and those with pregnancy-associated hypertension and diabetes or multiple gestations)
Exclusion Criteria:
Health pregnancies
Diagnostic Test: Optical coherence tomography
Patients with pre-existing diabetes who are pregnant
Diagnostic Test: Optical coherence tomography
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.
Diagnostic Test: Optical coherence tomography
Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints
Imaging Biomarkers: Choroid
Choroidal thickness
Time frame: during 9 months of pregnancy and in the 3 months after pregnancy
Imaging Biomarkers: Vessel density
Vessel density
Time frame: during 9 months of pregnancy and in the 3 months after pregnancy
Imaging Biomarkers: Foveal avascular zone (FAZ)
FAZ area
Time frame: during 9 months of pregnancy and in the 3 months after pregnancy
Fetal Health: delivery
Modality of delivery
Time frame: at time of birth
Fetal Health
weight of baby at birth
Time frame: at time of birth
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center