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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother, |
|
Intervention / Comparator Agent
|
|
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 |