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CTRI Number  CTRI/2024/08/071950 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Study to identify percentage of hypertensive disorders in antenatal patient having thallesemia,and to know their fetal outcome 
Scientific Title of Study   "Association of thallesemia trait or disease with PIH, preeclampsia, eclampsia and the fetal outcome among antenatal women attending OBGY opd of tertiary hospital Bhavanagar." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Rameshchandra Rachchh  
Designation  1st year resident  
Affiliation  Sir takhtsinhji general hospital and government medical College bhavnagar  
Address  Room no 2 and labour room Department of obstetrics and gynaecology Sir takhtsinhji hospital bhavnagar
Room no 2 and labour room Department of obstetrics and gynaecology Sir takhtsinhji hospital bhavnagar
Rajkot
GUJARAT
364001
India 
Phone  9033135992  
Fax    
Email  rachchhpooja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr kanaklata d nakum 
Designation  Additional proffesor 
Affiliation  Sir takhtsinhji general hospital and government medical College bhavnagar  
Address  Department of obstetrics and gynaecology sir takhtsinhji general hospital and government medical College bhavnagar
Subhasnagar, Near airport road, Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9033135992  
Fax    
Email  umesh.iucaa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Rameshchandra Rachchh  
Designation  1st year resident  
Affiliation  Sir takhtsinhji general hospital and government medical College bhavnagar  
Address  Department of obstetrics and gynaecology sir takhtsinhji general hospital and government medical College bhavnagar

Rajkot
GUJARAT
364001
India 
Phone  9033135992  
Fax    
Email  rachchhpooja@gmail.com  
 
Source of Monetary or Material Support  
Sir takhtsinhji hospital and government medical College, bhavnagar,pincode-364001,gujrat,india 
 
Primary Sponsor  
Name  Dr Pooja Rameshchandra Rachchh  
Address  Department of obstetrics and gynaecology sir takhtsinhji general hospital and 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 
Dr Pooja Rameshchandra Rachchh   Sir takhtsinhji general hospital bhavnagar   Department of obstetrics and gynaecology,room no 2 and labour room,sir takhtsinhji hospital and government medical College ,near jail road,bhavanagar
Bhavnagar
GUJARAT 		 9033135992

rachchhpooja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government medical College bhavnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Thalassemia trait or disease Pih Preeclampsia Eclampsia  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Inclusion Criteria :
•For cases:
•All antenatal patient in 1st trimester with low hemoglobin values(< 9gmsdl) or
•Any antenatal patient with RBC count >5.5 milion/mmc and pcv <38 or
•All antenatal patients with family history of hemoglobinopathies or blood transfusion.
•For controls: apperently healthy antenatal women

● Exclusion Criteria :NA 
 
ExclusionCriteria 
Details  Age less than 18 years
And. More than 45 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine association of maternal thalassemia trait and disease with PIH preeclampsia eclampsia and fetal outcome   At delivery  
 
Secondary Outcome  
Outcome  TimePoints 
To estimate proportion of thalassemia trait and disease among antenatal mother attending tertiary care hospital bhavnagar   18 month 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   16/08/2024 
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="0"
Months="10"
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   Thalassemia is one of the most common monogenic disorders. It affects hemoglobin production and is highly prevalent in Southeast Asia.
 
[1]. Hemoglobin is a protein in red blood cells which carries and transfers oxygen to all tissue and organs in the human body
 
[2]. Each hemoglobin molecule comprises a tetramer made of four globin subunits including two types, alpha and beta globin subunits, which are produced by alpha and beta genes, respectively.
 
[3] Therefore, thalassemia disorders depend on which globin gene is non-functioning, and is diagnosed as alpha or beta thalassemia.
Introduction
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•Generally, the prevalence of thalassemia carriers in Thailand is approximately 40%
 
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