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Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease for Pregnancy

N/A
Recruiting
Led By Avni P Finn, MD, MBA
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 9 months of pregnancy and in the 3 months after pregnancy
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 9 months of pregnancy and in the 3 months after pregnancy
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 9 months of pregnancy and in the 3 months after pregnancy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Imaging Biomarkers: Choroid
Imaging Biomarkers: Foveal avascular zone (FAZ)
Imaging Biomarkers: Vessel density
Secondary outcome measures
Fetal Health
Fetal Health: delivery

Trial Design

3Treatment groups
Experimental Treatment
Group I: Pregnant Patients with Vascular Disease or Risk Factors for Vascular DiseaseExperimental Treatment1 Intervention
Multiple gestations Preeclampsia or eclampsia Gestational diabetes Hypercoagulable state such as disseminated intravascular coagulation (DIC), thrombotic thrombocytopenic purpura (TTP), and hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome.
Group II: Pregnant Patients with Pre-Existing DiabetesExperimental Treatment1 Intervention
Patients with pre-existing diabetes who are pregnant
Group III: Healthy Pregnant PatientsExperimental Treatment1 Intervention
Health pregnancies

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,067 Total Patients Enrolled
Avni P Finn, MD, MBAPrincipal InvestigatorVanderbilt Eye Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~60 spots leftby Jan 2027