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CTRI Number  CTRI/2024/05/067080 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessment of impact of late-onset growth retardation on brain development of fetuses in comparison with normally growing fetuses using fetal MRI.  
Scientific Title of Study   Assessment of variability in cortical development in late-onset IUGR fetuses using foetal MRI. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akshat Rastogi 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiodiagnosis and Imaging, Kasturba Medical college, Manipal Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9919955226  
Fax    
Email  akshat.rastogi98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakashini K  
Designation  Professor  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Radiodiagnosis and Imaging, Kasturba Medical college, Manipal Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9845053325  
Fax    
Email  prakashini.k@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Prakashini K  
Designation  Professor  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Radiodiagnosis and Imaging, Kasturba Medical college, Manipal Udupi KARNATAKA 576104 India


KARNATAKA
576104
India 
Phone  9845053325  
Fax    
Email  prakashini.k@manipal.edu  
 
Source of Monetary or Material Support  
KASTURBA MEDICAL COLLEGE MANIPAL 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Kasturba Medical College, Manipal, Udupi, Karnataka- 576104 
Type of Sponsor  Private medical college 
 
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 Akshat Rastogi  Kasturba Hospital, Kasturba Medical College, Manipal  Room no. 3, Main MRI, Department of Radiodiagnosis and Imaging, Kasturba medical college, MAHE, Manipal Udupi KARNATAKA- 576104
Udupi
KARNATAKA 		 9919955226

akshat.rastogi98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba hospital institutional ethics committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O365||Maternal care for known or suspected poor fetal growth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Late onset IUGR Fetuses(greater than 32 weeks of gestational age) as per antenatal scan criteria
2. Appropriate for gestational age fetuses( greater than 32 weeks of gestational age) as per antenatal scan criteria 
 
ExclusionCriteria 
Details  1. Motion artifacts during MRI acquisition
2. Incidentally diagnosed brain pathologies
3. Multiple Pregnancies
4. Chronic Maternal disease
5. Perinatal Infections 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Does intra-uterine growth restriction affect cortical development? Yes/ No
2. Fetal MRI cortical development parameter(s) that showed significance and their recommended cutoffs
 		 Greater than 32 weeks of gestational age
 
 
Secondary Outcome  
Outcome  TimePoints 
Perinatal outcome is affected in IUGR Foetuses:
Yes/No 		 At birth of the fetus 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   19/05/2024 
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="2"
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   The study will enroll all clinically referred participants based on specific inclusion and exclusion criteria during the designated period. Demographic details in the form of age, hospital number, and period of gestation as per last USG would be recorded. Written informed consent will be taken from the patients and PCPNDT F form would be filled and signed by the radiologist and the patient.
 Imaging process will be performed after 4 hours of fasting and without sedation, while the patient will be positioned in supine. Brain MRI will be taken at 3 different orthogonal planes. If motion artifact degradation is detected, the sequence will be repeated until a satisfactory image is obtained. 
Following parameters will be measured and recorded: 
 Fissure depths- Biparietal diameter, Bilateral insular depths, bilateral cingulate fissure depths 
Cortical thickness- Bilateral insula, temporal lobe, frontal lobe, occipital lobe, corpus callosum length Area- 
Areas: Whole brain area, Cerebellum, Corpus callosum
 The patient will be followed up till birth and following perinatal outcomes would be assessed at birth Gestational age at birth(weeks), birthweight (in grams), Neonatal acidosis, APGAR score at 5 mins, NICU stay length(days), Other perinatal complications. Radiological findings would be analyzed and statistically significant parameters would be put forth as neuro-imaging biomarkers for assessing cortical development in-utero. If any incidental pathology/defect is discovered in the foetus, findings will be communicated to the referring obstetrician to decide the further course of action.
 
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