Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Placental Insufficiency
- 发起方
- Assistance Publique - Hôpitaux de Paris
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Establishment of physiological reference range of placental perfusion
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.
详细描述
Objective: To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center. Method: All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study. 120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG. MRI will be performed in the same hospital, during hospital stay, within 45 minutes. Two MRI sequences will be used to measure placental perfusion: * dynamic sequences using Gd contrast agent. * " spin tagging ", which do not need any contrast agent. Perfusion will be modelled using compartmental analysis. Reference ranges will be build up by statistical modelling. Gadolinium assays will be performed on amniotic fluid and placental tissue following TOP. Duration of inclusion: 24 months. Duration of patient participation: 45 minutes. Expected results: * Feasibility in routine practice. * Reference ranges for placental perfusion. * Comparison between the two measurements methods. Adverse outcome measure: Nausea, vomiting, lack of comfort and other adverse outcome.
研究者
入排标准
入选标准
- •Women \> 18 years,
- •Undergoing TOP for fetal reason,
- •Informed signed consent.
排除标准
- •Placental adhesion anomaly,
- •Growth restriction,
- •Contrast agent allergy,
- •Absent consent,
- •Contraindication of MRI or Gadolinium,
- •Renal insufficiency,
- •Placental abnormality at pathological examination.
结局指标
主要结局
Establishment of physiological reference range of placental perfusion
时间窗: 45 MIN
Establishment of physiological reference range of placental perfusion
次要结局
- To quantify in vivo and by a not invasive way the microscopic physiological phenomena relative to the placental perfusion and in the local transcapillary exchanges of the placenta(45 MIN)
- Comparison between the two measurements methods.(45 MIN)