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临床试验/NCT01100697
NCT01100697已完成不适用

Fetal Spina Bifida -Prenatal Course and Outcome in 103 Cases A Single Center Experience.

University of Luebeck1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
1
主要终点
Infant bladder and bowel function

研究概览

简要总结

Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to long-time survival. Concerning psychomotor development as well as urinary bladder and intestinal morbidity the prognosis ranges from normal functional outcome to severe disability.

The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound screening allows patients to prepare for the birth of an impaired child or to consider termination of the pregnancy. In current practice, prenatal counseling and obstetric management depend not only on the detection of a spinal dysraphism but also on an appropriate assessment of the severity of the defect and its possible impact on the postnatal development of the affected child.

Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on the postnatal outcome. Previous studies reported that postnatally determined lesion levels correlated well with functional status and survival. On the contrary, it is still not clear whether similar data obtained antenatally are of value.

In this study, the investigators will review their database of all cases of prenatally diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the prenatal and postnatal characteristics of fetuses with spina bifida in relation to the anatomic level of the lesion, the investigators aim to contribute further information regarding the natural course of affected pregnancies and the correlation of prenatal ultrasound findings with their functional outcome.

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
12 Weeks 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • spina bifida identified at prenatal ultrasound examination
  • ultrasound diagnosis between 1993 - 2009

排除标准

  • deviant postnatal diagnosis
  • loss to follow-up
  • incomplete data

结局指标

主要结局

Infant bladder and bowel function

时间窗: 17 yrs

Degree of continence.

Infant psychomotor development

时间窗: 17 yrs

Kaufmann ABC Denver Developmental Screening Test walking ability muscle strenght

pregnancy outcome

时间窗: 17 yrs

To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.

次要结局

  • Conception date(17 yrs)
  • spectrum of ultrasound signs(17yrs)

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Alexander Beyer

Dr. D. A. Beyer

University of Luebeck

研究点 (1)

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