Optical Coherence Tomography for Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand changes in the retina and choroid (parts of the eye) during pregnancy. Researchers will take non-invasive photos of participants' eyes at three stages: early pregnancy, late pregnancy, and after delivery. The study includes healthy pregnant women, those with vascular issues like preeclampsia, and those with pre-existing diabetes. Pregnant women in their first or second trimester who can give informed consent might be suitable candidates. This research could help doctors better understand eye health and pregnancy outcomes. As an unphased trial, the study offers participants the chance to contribute to foundational research that could enhance pregnancy care and understanding of eye health.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that optical coherence tomography is safe for pregnant patients?
Research has shown that optical coherence tomography (OCT), a type of eye scan used in the study, is generally safe and well-tolerated. OCT is non-invasive, as it does not involve surgery or entering the body. It uses light waves to capture images of the retina, the back part of the eye, without touching the eye's surface.
In terms of safety, OCT does not use ionizing radiation, which can be harmful at high levels. This makes OCT safer than imaging methods that do use such radiation. Studies have found no evidence that OCT harms adults or unborn babies during pregnancy. While some imaging methods might slightly affect an unborn baby, OCT does not carry this risk.
Overall, OCT is considered a safe way to study changes in the eye, even during pregnancy. Participants in this study will have special eye photos taken without any direct contact with the eye, enhancing its safety.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to explore how pregnancy affects retinal blood vessels, especially in women with different health conditions. Unlike standard care that primarily focuses on managing existing conditions like diabetes or preeclampsia during pregnancy, this study could reveal new insights on how these conditions influence eye health specifically. By comparing healthy pregnancies to those with vascular diseases or diabetes, researchers hope to uncover potential early indicators of retinal changes, leading to better prevention and management strategies for eye health in pregnant women.
What evidence suggests that optical coherence tomography is effective for assessing retinal changes during pregnancy?
Research has shown that optical coherence tomography (OCT), a special eye scan used in this trial, can detect important changes in the eyes during pregnancy. Participants include healthy pregnant patients, those with vascular disease or risk factors, and those with pre-existing diabetes. Studies have found that in conditions like gestational diabetes and preeclampsia, OCT can identify changes in the small blood vessels in the retina before symptoms appear. These changes include differences in the size and shape of the blood vessels. One study discovered that these retinal changes can be seen as early as the first trimester in pregnancies at risk for preeclampsia. This suggests that OCT could help monitor and predict pregnancy complications by examining the eye's blood vessels.678910
Who Is on the Research Team?
Avni P Finn, MD, MBA
Principal Investigator
Vanderbilt Eye Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early Pregnancy Imaging
Specialized photos of the eye are taken early in pregnancy (first or second trimester) to assess retinal and choroidal changes.
Late Pregnancy Imaging
Specialized photos of the eye are taken late in pregnancy (third trimester) to assess retinal and choroidal changes.
Post-Delivery Imaging
Specialized photos of the eye are taken after delivery to assess retinal and choroidal changes.
Follow-up
Participants are monitored for safety and effectiveness after the imaging phases.
What Are the Treatments Tested in This Trial?
Interventions
- Optical coherence tomography
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
Patients with pre-existing diabetes who are pregnant
Health pregnancies
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Citations
Exploring the effect of gestational diabetes mellitus on retinal ...
There were increases in RVOD, RVLD, VWT, and VWCSA, decrease in AVR in patients with GDM. However, no significant difference of retinal vascular ...
Noninvasive early prediction of preeclampsia in pregnancy ...
Our study demonstrated that the retinal vascular alterations were found in the first trimester of pregnancy, much prior to the PE diagnosis, ...
Maternal Optical Coherence Tomography Angiography ...
There was no significant difference in chronic hypertension (P = 1.0), gestational hypertension (P = 1.0), type 1/2 diabetes (P = 1.0), gestational diabetes (P ...
Investigation of the effects of gestational diabetes and ...
The study by Doğan and Erkan Pota (2023) explored the effect of GDM and Preeclampsia (PIH) on the microvasculature of the retina and choroid, ...
Optical coherence tomography angiography findings in ...
In preeclampsia, OCTA shows changes in the microvascular structure of the retina, even without retinopathy findings on biomicroscopy examination.
The utility of wide-field optical coherence tomography ...
However, this has risks of unpleasant and potentially dangerous side effects, with an added theoretical risk to the fetus in pregnancy. Wide- ...
CT safety during pregnancy
An unborn baby exposed to CT during pregnancy may have about a one in 1,000 greater chance of developing a cancer as a child. The level of risk is not proven ...
Endoscopic optical coherence tomography in the diagnostic ...
In recent years, the compelling imaging capabilities and safety features of endoscopic OCT have rendered it highly attractive for uterine cavity ...
Safety of Radiographic Imaging During Pregnancy
The accepted cumulative dose of ionizing radiation during pregnancy is 5 rad, and no single diagnostic study exceeds this maximum.
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bmcoralhealth.biomedcentral.com
bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-021-01726-6Women's awareness regarding the use of dental imaging ...
In a study by Aboalshamat et al., 67% of dentists considered periapical radiographs safe only during the second trimester. Panoramic radiographs ...
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