Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Poor neonatal status
研究概览
简要总结
The purpose of this study is to compare the apparent diffusion coefficient in the frontal lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared with foetuses with intra-uterine growth restriction and a good neonatal outcome.
详细描述
Intra-uterine growth restriction is associated with an increased risk of perinatal morbimortality. The objective of foetal monitoring is to assess foetal growth, foetal well-being and to evaluate ability to adapt to chronic hypoxia.
The primary objective in antenatal care is to ischemic cerebral lesions. However, there is currently no relevant prenatal exam predictive for the risk of such lesions.
Foetal cerebral MRI could highlight changes in Apparent Diffusion Coefficient (ADC) in some frontal cerebral territories in foetuses with intra-uterine growth restriction and poor neonatal outcome.
These changes could be associated with a transient cerebral ischemia. The study of ADC could be a useful tool in the prognostic evaluation of these foetuses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •single pregnancy
- •estimated foetal weight ≤ 5th percentile
- •agreeing to participate
- •women age ≥ 18 years of age, speaking and understanding French language
- •covered by the French social security system
排除标准
- •foetal malformation or foetal karyotype abnormal
- •infectious foetopathy
- •multiple pregnancy
- •refusal to participate
- •pregnant women aged < 18 years old
- •pregnant women not understanding or speaking French language
- •not covered by French social security
- •contraindication to MRI
结局指标
主要结局
Poor neonatal status
时间窗: At birth
Neonatal death; Apgar score \< 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH \< 7.10
次要结局
- Neonatal status at neonatology unit discharge(up to 20 weeks)
- Poor neonatal status(until 30 days of life)
- Neurological development(At 2 years of age (adjusted age))