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CTRI Number  CTRI/2024/07/070057 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A study to predict gestational diabetes in Ist trimester of pregnancy.  
Scientific Title of Study   A multifactorial study of maternal physical, psychological and health parameters for early prediction of gestational diabetes mellitus in pregnant women. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Seveka Bali 
Designation  Physiotherapist 
Affiliation  PGIMER,Chandigarh 
Address  New OPD,PGIMER , sector 12, Chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8722324705  
Fax    
Email  17seveka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sonia singh 
Designation  Assistant Professor 
Affiliation  Punjabi university,Patiala 
Address  Physiotherapy department, Punjabi University, Patiala

Patiala
PUNJAB
147002
India 
Phone  9872637661  
Fax    
Email  soniaphysio239@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Seveka Bali 
Designation  Physiotherapist 
Affiliation  PGIMER,Chandigarh 
Address  New OPD,PGIMER , sector 12, Chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8722324705  
Fax    
Email  17seveka@gmail.com  
 
Source of Monetary or Material Support  
Gynecology department, PGIMER,Chandigarh,India,160012 
 
Primary Sponsor  
Name  Seveka Bali 
Address  PGIMER, Sector 12,Chandigarh,India,160012 
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 Seveka Bali  Post Graduate Institute of Medical Education and Research   Room no.2053,antenatal unit,Gynecology department, PGIMER, Chandigarh
Chandigarh
CHANDIGARH 
8722324705

17seveka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research,Chandigarh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant females in their first trimester are the participant of this study. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Age 18 years or greater
2.Pregnant females in their Ist trimester
 
 
ExclusionCriteria 
Details  Pregnant females with ectopic pregnancy, renal, hepatic, endocrinal,and metabolic disorders, on medication for diabetes and hypertension, psychiatric illness, or any neuromuscular problem will be excluded  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gestational diabetes mellitus  24-28 weeks of pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="201"
Sample Size from India="201" 
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)   15/10/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 research proposal focuses on predicting gestational diabetes mellitus (GDM) in pregnant women by analyzing a range of physical, psychological, and health parameters. It begins by highlighting the complexities of pregnancy and the potential risks associated with GDM, including adverse outcomes for both mother and child. The proposal emphasizes the importance of early detection and intervention to mitigate these risks.
The study aims to fill existing gaps in research, particularly in the Indian context, by investigating various predictors of GDM during the first trimester of pregnancy. These predictors include biomarkers, hematological markers, physical factors such as BMI and physical activity, psychological factors like perceived stress, and health parameters like blood pressure.
The proposed methodology involves a prospective case-control study conducted among pregnant women attending a gynecological department. Data collection will include demographic information, anthropometric measurements, biochemical and hematological tests, physical activity assessments, and stress evaluations. Participants will be followed up until the end of pregnancy, with GDM diagnosis based on established criteria.
Data analysis will involve statistical techniques such as logistic regression to identify significant predictors of GDM.
The study will contribute valuable insights into the predictors of GDM during the first trimester of pregnancy, ultimately assisting healthcare professionals in implementing effective preventive measures and management strategies.
 
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