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临床试验/NCT05033275
NCT05033275终止不适用

Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
1
主要终点
Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound

研究概览

简要总结

Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis

详细描述

Parent/s of babies born to mothers with pregestational diabetes who have normal clinical examination and have no radiographs showing a normal sacrum will be approached for a spinal US

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Infants born to mothers with pregestational diabetes
  • Normal spinal examination

排除标准

  • Infants born to mothers with pregestational diabetes
  • Abnormal spinal examination such as a sacral dimple
  • Radiograph with abnormal sacrum
  • Spanish speaking parents

结局指标

主要结局

Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound

时间窗: 12 months

All babies who have tethered cord on spinal US will be referred to neurosurgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akshaya Vachharajani

Professor of Pediatrics

University of Missouri-Columbia

研究点 (1)

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