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临床试验/NCT03356314
NCT03356314已完成不适用

Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of The Relative Position of The Superior Mesenteric Artery and Vein. Future of the Children With an Antenatal Malrotation Suspicion

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9,000
试验地点
1
主要终点
Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels

研究概览

简要总结

The aim of this study was to assess the value of an unusual relative position of the superior mesenteric artery (SMA) and vein (SMV) to screen intestinal malrotation with a higher risk of volvulus.

First, feasibility study was done to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.

A systematic screening of the mesenteric vessels position was performed at each pregnancy required ultrasound.

When the fœtus had an unusual position of the mesenteric vessels, an MRI was suggested between 30 and 35 GA and the couple met the pediatric surgery team.

Few days after birth, an abdominal ultrasound was achieved as well as a barium enema and upper gastrointestinal. If there were a hight probability of malrotation with a higher risk of volvulus, a prophylactic surgery was proposed. The children were flollowed up during 1 year.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels

时间窗: 1 day (Pre and post natal ultrasound)

Feasibility study to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.

Antenatal screening of intestinal malrotation

时间窗: 1 day (Pre and post natal ultrasound)

Antenatal screening of intestinal malrotation with higher risk of volvulus.

Future of the children with an ante natal diagnosis of intestinal malrotation

时间窗: 1 year after birth

Future of the children with an ante natal diagnosis of intestinal malrotation

次要结局

  • Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.(1 day (after delivery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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