Understanding Retinal Vascular Changes During Pregnancy and the Impact on Maternal and Fetal Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Imaging Biomarkers: Vessel density
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient age 18 years and older
- •Patient able to provide informed consent
- •Pregnant at time of enrollment and in the 1st or 2nd trimester of pregnancy
排除标准
- •Other ocular disease that prevents imaging (significant cataract or other media opacity)
- •Unable to comply with imaging or follow-up through duration of study
结局指标
主要结局
Imaging Biomarkers: Vessel density
时间窗: during 9 months of pregnancy and in the 3 months after pregnancy
Vessel density
Imaging Biomarkers: Choroid
时间窗: during 9 months of pregnancy and in the 3 months after pregnancy
Choroidal thickness
Imaging Biomarkers: Foveal avascular zone (FAZ)
时间窗: during 9 months of pregnancy and in the 3 months after pregnancy
FAZ area
次要结局
- Fetal Health: delivery(at time of birth)
- Fetal Health(at time of birth)
研究者
Avni Finn
Principal Investigator, Medical Director of Imaging
Vanderbilt University Medical Center