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CTRI Number  CTRI/2023/01/049227 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 24/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   TYPES OF ANEMIA IN PREGNANT WOMEN  
Scientific Title of Study   Study of morphological types of anemia in antenatal women at teritary care hospital:a cross sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GEETHU KRISHNAN 
Designation  First Year PG Resident,Pathology 
Affiliation  SIR T HOSPITAL/GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR 
Address  First year pg resident pathology, department of pathology, Government medical college, bhavnagar.
First year pg resident pathology, department of pathology, Government medical college, bhavnagar.
Bhavnagar
GUJARAT
364001
India 
Phone  9497677347  
Fax    
Email  geethurahul17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DRPRAGNESHHSHAH 
Designation  Professor in department of pathology  
Affiliation  SIR T HOSPITAL/GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR 
Address  Blood bank,Sir T General hospital,Bhavnagar.
Blood bank,Sir T General hospital,Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9428106604  
Fax    
Email  drphshah73@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  GEETHU KRISHNAN 
Designation  First Year PG Resident,Pathology 
Affiliation  SIR T HOSPITAL/GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR 
Address  Department of pathology, Government medical college bhavnagar.
Department of pathology, Government medical college bhavnagar.
Bhavnagar
GUJARAT
364001
India 
Phone  9497677347  
Fax    
Email  geethurahul17@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR 
 
Primary Sponsor  
Name  GEETHU KRISHNAN 
Address  First year pg resident, Department of pathology, Government medical college,Bhavnagar. 
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 
GEETHU KRISHNAN  Sir T General Hospital  Central Pathology laboratory Sir T General hospital,Bhavnagar.
Bhavnagar
GUJARAT 
9497677347

geethurahul17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Government Medical College,Bhavnagar.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  BLOOD SAMPLES FROM ANEMIC ANTENATAL PATIENTS 
 
ExclusionCriteria 
Details  K/C/O HEMOGLOBINOPATHIES 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
CATEGORIZE MORPHOLOGICAL TYPES OF ANEMIA IN ANTENATAL PATIENTS.  AT END OF STUDY 
 
Secondary Outcome  
Outcome  TimePoints 
CORRELATE MORPHOLOGICAL TYPES OF ANEMIA WITH TRIMESTER OF PREGNANCY.
CATEGORIZE SEVERITY OF ANEMIA 
1 YEAR 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
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)   30/01/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
1st step: After Ethics committee Bhavnagar approval. Study will be conducted on sample received
in hematology laboratory, Sir T hospital, Bhavnagar.
2nd step: Data from Automated cell analyzer will be assessed to find samples having low hemoglobin
levels according to WHO reference values.
3rd step: This low hemoglobin samples will become the study group.
4th step: Peripheral blood smear will be prepared of the same and reporting will be done by primary
investigator.
5th step: Morphological typing of anemia will be done based on RBC indices and RDW obtained from
automated cell counter as well as blood smear.
6th step: Studied data will be analyzed and complied in master chart.
7th step: After tabulation of data, statistical analysis will be done.
8th step: Data will be categorized and analyzed based on numbers, percentage, and frequency
 
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