Characterization of Placental Diffusion in Women With Diabetes Using DW-MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Placental diffusion coefficient (D) measured by IVIM-DWI
研究概览
简要总结
DW-MRI Allows a quantitative comparison of diffusion as an expression of tissue hypoxia. The investigators aim is to compare changes in placental diffusion in pregnant women with uncontrolled diabetes compared to healthy pregnant women using DW-MRI.
The investigators hypothesize that placentas of diabetic mothers will show lower diffusion / perfusion compared to placentas of healthy women.
详细描述
In highly uncontrolled diabetes there is an increased risk of intrauterine fetal death. The mechanism of fetal death is unknown and unpredictable. One of the theories points to hypoxia as a precursor to the death of the fetus in the womb. If the researchers succeed in predicting changes in the placenta with the help of MRI, it may be possible to understand the mechanism of fetal damage as well as in the future to develop a protocol for predicting pregnancies prone to fetal death in the womb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with PGAM (Pre-gestational diabetes) diagnosed before 20 weeks of pregnancy
- •Women with GDMA (Gestational diabetes) diagnosed by OGTT after 20 weeks of pregnancy
排除标准
- •pregnant women with placental hypoxia disease related in the past
- •pregnant women with placental hypoxia disease related in the present
- •non-singleton pregnancy
- •women in active labor or rupture of membrane
- •smoking women
- •suspicion of placenta accreta
研究组 & 干预措施
Pregnant women with gestational diabetes mellitus
3Th trimester pregnant women with gestational diabetes mellitus
干预措施: DW-MRI (Diagnostic Test)
Low risk pregnant women
3Th trimester pregnant women with unknown diseases (low risk factors)
干预措施: DW-MRI (Diagnostic Test)
结局指标
主要结局
Placental diffusion coefficient (D) measured by IVIM-DWI
时间窗: Two years
Placental diffusion coefficient (D, mm²/s) derived from intravoxel incoherent motion diffusion-weighted MRI (IVIM-DWI). Mean D values will be extracted from whole-placenta regions of interest and compared between parturients with poorly controlled diabetes and excessive fetal growth and low-risk parturients with appropriately grown fetuses.
次要结局
- Placental perfusion fraction (f) measured by IVIM-DWI(Two years)