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临床试验/NCT01092949
NCT01092949
已完成
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Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 135 人2010年2月1日

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.

注册库
clinicaltrials.gov
开始日期
2010年2月1日
结束日期
2018年9月1日
最后更新
上个月
研究类型
Observational
性别
Female

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)

研究点 (1)

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