Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
试验速览
- 阶段
- 不适用
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Choroidal thickness
研究概览
简要总结
It has been known that a pregnant women undergoes significant anatomical and physiological changes that mainly caused by hormonal and hematologic changes during pregnancy. Due to advance in reproductive medicine, the incidence of multifetal pregnancy was increased to 3% of livebirth. Multifetal pregnancies produce much more physiological changes in the body compared to the singleton pregnancies.
Physiologic ocular changes during pregnancy are the followings
- Melanogenesis of eyelid and facial skin
- Cellular alteration of lacrimal and meibomian gland
- Increased corneal thickness and corneal curvature
- Increased lens thickness
- Increased retinal vascular density
- Increased choroidal thickness Decreased intraocular pressure -
详细描述
From the literature review, there was only on study of ocular changes in twin pregnancies. Alim et al evaluated the choroidal and retinal thickness in singleton versus twin pregnancies. They included 20 single and 20 twin pregnant women in their 3rd trimester with 20-age-matched healthy non-pregnant women as a control group. They found that there was an increase in choroidal thickness in the 3rd trimester of pregnancies and it was prominent in twin pregnancies. There was a statistically significant difference in choroidal thickness between pregnant and non-pregnant women, but not significant difference between singleton and twin pregnancies. The mean retinal nerve fiber layer thickness was significantly higher in the twin pregnancy group than in the singleton pregnancy group. However, no study of retinal vascular density in twin pregnancies has been published before.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •24-37 years
- •30-36 weeks of gestational age
- •clear ocular media
- •written informed consent
排除标准
- •high risk pregnancies such as pre-eclampsia, gestational diabetic mellitus and asthma
- •history of refractive error, spherical equivalent > 3 diopters
- •history of retinal diseases such as central serous chorioretinopathy and retinal vascular occlusion
- •history of intraocular inflammation or endophthalmitis
- •history of intraocular laser treatment
- •history of intraocular surgery
研究组 & 干预措施
multifetal pregnancy in the 3rd trimester
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
干预措施: Corneal tomography, optical coherence tomography and optical coherence tomography angiography (Device)
singleton pregnancy in the 3rd trimester
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
干预措施: Corneal tomography, optical coherence tomography and optical coherence tomography angiography (Device)
age-stratified healthy non-pregnant women
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed.
干预措施: Corneal tomography, optical coherence tomography and optical coherence tomography angiography (Device)
结局指标
主要结局
Choroidal thickness
时间窗: 30-36 weeks of gestational age
Choroidal thickness was measured by optical coherence tomography.
次要结局
- Corneal thickness(30-36 weeks of gestational age)
- Retinal vascular density(30-36 weeks of gestational age)
- Retinal nerve fiber layer thickness(30-36 weeks of gestational age)
研究者
Suthasinee Sinawat
Associate Professor
Khon Kaen University