跳至主要内容
临床试验/CTRI/2025/07/091568
CTRI/2025/07/091568尚未招募不适用

Quantitative and Qualitative evaluation of Kidney of Anencephalic foetus

Dr SURBHI WADHWA1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年8月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
Volume of the whole Kidney.

研究概览

简要总结

Neural tube defects (NTDs) are congenital abnormalities resulting from improper neural tube closure during early embryonic development. These range from total failure of neural tube closure (craniorachischisis) to partial closures, such as anencephaly (cephalic end) and spina bifida (caudal end). In India, NTDs occur at a rate of approximately 4.1 per 1000 births, with anencephaly accounting for 2.1 per 1000. Anencephaly is a fatal condition where infants are born without a functional cerebrum, remain unconscious, and have a high mortality rate post-birth, although vital functions like breathing and heartbeat may remain temporarily intact. Despite associated malformations, the organs—especially kidneys—can be viable for transplantation if protected from hypoxic damage.

India faces a significant shortage in kidney donations, with only 7500 transplants performed annually out of 220,000 required. Anencephalic infants are considered potential organ donors, with successful kidney transplants from such donors reported as early as 54 years ago.

This study proposes to compare the kidney structures of anencephalic and normal fetuses using stereology, a statistical technique that allows precise three-dimensional quantification of kidney tissue based on two-dimensional histological sections.

研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Month(s) 至 6.00 Month(s)(—)
性别
All

入选标准

  • Mid-trimester aborted foetuses with anencephaly with no documented anomaly in Kidney by ultrasound.
  • Mid-trimester aborted normal foetuses with no documented anomaly in Kidney by ultrasound.

排除标准

  • Macerated foetuses.
  • Putrified foetuses.
  • Foetuses with congenital anomaly in kidney.
  • Foetuses with a congenital anomaly other than Anencephaly.

结局指标

主要结局

Volume of the whole Kidney.

时间窗: Outcomes will be measured only once at baseline

Volume of Nephrogenic zone.

时间窗: Outcomes will be measured only once at baseline

Volume of Cortex and Medulla.

时间窗: Outcomes will be measured only once at baseline

Number of Glomeruli.

时间窗: Outcomes will be measured only once at baseline

次要结局

  • Comparison of the histological differences in the kidneys of the anencephalic & normal foetuses.(Comparison of the quantitative features of the kidneys of anencephalic & normal foetuses.)

研究者

发起方
Dr SURBHI WADHWA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Surbhi Wadhwa

Maulana Azad Medical College

研究点 (1)

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