| 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
|
|
|
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
|
|
|
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. |