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CTRI Number  CTRI/2025/07/091568 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Quantitative and Qualitative evaluation of Kidney of Anencephalic foetus  
Scientific Title of Study   Quantitative and Qualitative evaluation of Kidney of Anencephalic foetus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
F.1/IEC/MAMC/MD/MS(108/01/2024/No.77  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surbhi Wadhwa 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anatomy Maulana Azad Medical College and Associated Hospitals New Delhi 110002

Central
DELHI
110002
India 
Phone  9818375337  
Fax    
Email  wadhwa.surbhi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surbhi Wadhwa 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anatomy Maulana Azad Medical College and Associated Hospitals New Delhi 110002

Central
DELHI
110002
India 
Phone  9818375337  
Fax    
Email  wadhwa.surbhi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surbhi Wadhwa 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anatomy Maulana Azad Medical College and Associated Hospitals New Delhi 110002

Central
DELHI
110002
India 
Phone  9818375337  
Fax    
Email  wadhwa.surbhi@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, Bahadur Shah Zafar Road, New Delhi, Pin 110002 
 
Primary Sponsor  
Name  Dr SURBHI WADHWA 
Address  Department of ANATOMY Maulana Azad Medical College and Associated Hospitals New Delhi 110002 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surbhi Wadhwa  Maulana Azad Medical College  Department of Anatomy Maulana Azad Medical College and associated hospitals, New Delhi, Pin 110002
Central
DELHI 
9818375337

wadhwa.surbhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  4.00 Month(s)
Age To  6.00 Month(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  Macerated foetuses.
Putrified foetuses.
Foetuses with congenital anomaly in kidney.
Foetuses with a congenital anomaly other than Anencephaly.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Volume of the whole Kidney.
Volume of Nephrogenic zone.
Volume of Cortex and Medulla.
Number of Glomeruli.
 
Outcomes will be measured only once at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 
Outcomes will be measured only once at baseline 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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