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临床试验/NCT03315637
NCT03315637招募中不适用

Fetal Endoscopic Surgery for Spina Bifida

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)

研究概览

简要总结

This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.

详细描述

Introduction:

Spina bifida is a congenital malformation characterized by a failure in neural tube closure. Unprotected fetal neural tissue at the spine level undergoes not only progressive neurodegeneration in spinal cord, but also the impairment in brain development, hindbrain herniation or Chiari II malformation probably due to pressure disturbances resulting from a continuous leakage of cerebrospinal fluid through the defect. The neurological consequences at birth are irreversible and sometimes devastating, including paraplegia, sphincter urinary and fecal incontinence, hydrocephalus, cranial nerve disturbances, respiratory problems and death due to spinal cord injury and brain maldevelopment.

Intrauterine fetal open repair of the defect has proved to improve hindbrain herniation and decrease the need of cerebrospinal shunting.

Hypothesis:

The investigators hypothesize that minimally invasive surgery of spina bifida is feasible and may minimize surgical aggression and obstetrical complications, with similar neonatal and neurological results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Maternal age > 18 years old
  • Singleton pregnancy
  • Gestational age between 18 0/7 weeks and 26 6/7 weeks
  • Isolated neural tube defect between T1 and S1
  • Cerebellar herniation (Chiari type II)

排除标准

  • Fetal anomalies non related to neural tube defect (NTD) including chromosomal abnormalities
  • Body mass index > 35 kg/m2
  • Maternal disorders contraindicating surgery
  • Genetic anomalies with poor prognosis
  • Sever kyphosis (>30º)

研究组 & 干预措施

Fetoscopic repair of spina bifida

Experimental

This is a single arm study, all patients will receive a fetoscopic repair of the spina bifida

干预措施: Fetoscopic repair of spina bifida (Procedure)

结局指标

主要结局

Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)

时间窗: Time of procedure (day 0)

Binary variable (yes/no) describing if the neural tube defect has been successfully closed, (placode dissected and dropped into the open spinal canal, cystic tissue resected and edges closed to the midline), by fetoscopic surgery, and without conversion to open surgery

次要结局

  • Operating time (minutes)(Time of procedure (day 0))
  • Fetoscopy time (minutes)(Time of procedure (day 0))
  • Hospital stay (days)(Between procedure and delivery, up to 21 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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