LUMIERE on the PLACENTA : A Study on the Added Value of MRI
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in placental blood flow as seen in vascular IUGR
研究概览
简要总结
The frequency of IUGR is between 3 and 10% of births. The etiologies and mechanisms of IUGR are multiple. The placental insufficiency, that is the defect of perfusion, is, however, the principal mechanism, far in front of other maternal or fetal causes. This placental insufficiency is also now recognized as an essential risk factor for cardiovascular and metabolic diseases, such as diabetes, in adulthood. The interest in understanding in utero development is thus further increased by the short-, medium- and long-term consequences of placental dysfunction. However, there are few ways to evaluate uteroplacental vascularization in vivo. MRI is an imaging technique used routinely in the exploration of the fetus in addition to ultrasound. Its safety on the fetus and the mother is largely demonstrated at 1.5T. There are also MRI sequences used daily in the clinic to evaluate perfusion and organ structure in children and adults (brain, kidney, heart, etc.). Their application for evaluation of perfusion and placental structure, although still confined to research, is very promising. The investigator's team has extensive experience, in animals or in children, in the use of these sequences that could be used to evaluate placental function in vivo. The ASL (Arterial Spin Labeling) in particular is the most encouraging functional imaging technique because it allows today to measure an organ blood flow quantitatively and without injection of contrast medium.
详细描述
The inclusion will take place at the earliest at 20 weeks after the completion of the standard morphological ultrasound of the 2nd trimester (carried out at 20-24SA) and at the latest at 35 SA, within the framework of one of the 2 clinical subgroups of patients considered (high risk and low risk).
The objectives of this study will be achieved by the prospective setting up of a LUMIERE cohort on PLACENTA.
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
- •Singleton pregnancy without fetal malformation seen on ultrasound. Group 1: High risk IUGR patients
- •EPF<10th perc or PA<10th perc and Doppler ombilical IP> 95th percentile,
- •EPF or PA<3th perc reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW,
- •Group 2: Low risk IUGR patients
- •EPF et PA>20th perc reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW
排除标准
- •- Contraindication to MRI
- •Impossible subsequent follow up
- •Maternal status contraindicates continuation of pregnancy
- •Participation in another search
- •"Protected" patient
结局指标
主要结局
Changes in placental blood flow as seen in vascular IUGR
时间窗: From inclusion to end of neonatal period (max 25 weeks)
25% reduction in overall placental perfusion measured ASL with IUGR (defined as \<3th perc birth weight) versus controls (birth weight\> 10th perc)
次要结局
- structural changes of the placenta(From inclusion to end of neonatal period (max 25 weeks))
- evaluation of liver resonance(From inclusion to end of neonatal period (max 25 weeks))
- Uterine arteries(From inclusion to end of neonatal period (max 25 weeks))
- Measurement of IUGR by fetal segmentation (MRI),(From inclusion to end of neonatal period (max 25 weeks))
- evaluation of kidney resonance(From inclusion to end of neonatal period (max 25 weeks))
- Acceptability of the examination for the patient: questionnaire(at IRM examination)
- Measurement of placental volume(From inclusion to end of neonatal period (max 25 weeks))
- Placental response to maternal oxygenation (BOLD)(From inclusion to end of neonatal period (max 25 weeks))
- Acceptability of the examination for the patient: Likert scale(at IRM examination)
- Specific Absorption Rate for each type of sequence(From inclusion to end of neonatal period (max 25 weeks))
- evaluation of brain resonance(From inclusion to end of neonatal period (max 25 weeks))
- Reproducibility of the examination analysis(After study completion, an average of one year)
