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CTRI Number  CTRI/2018/05/013946 [Registered on: 17/05/2018] Trial Registered Prospectively
Last Modified On: 19/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Gestational Diabetes Study 
Scientific Title of Study   Markers For Early Risk-Stratification Of Gestational Diabetes (MERGD)”: A Prospective Cohort Study  
Trial Acronym  MERGD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manju Mamtani 
Designation  General Manager, M&H Research, LLC, San Antonio, TX 
Affiliation  Trustee, Lata Medical Research Foundation 
Address  C/o 9/1, Kinkine Kutir Vasant Nagar,
C/o 9/1, Kinkine Kutir Vasant Nagar,
Nagpur
MAHARASHTRA
440022
India 
Phone  9823350019  
Fax    
Email  manjuhemant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manju Mamtani 
Designation  General Manager, M&H Research, LLC, San Antonio, TX 
Affiliation  Trustee, Lata Medical Research Foundation 
Address  C/o 9/1, Kinkine Kutir Vasant Nagar,
C/o 9/1, Kinkine Kutir Vasant Nagar,
Nagpur
MAHARASHTRA
440022
India 
Phone  9823350019  
Fax    
Email  manjuhemant@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Archana Patel 
Designation  Program Director and CFO 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India 
Phone  7122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Source of Monetary or Material Support  
Lata Medical Research Foundation, Nagpur 
 
Primary Sponsor  
Name  Lata Medical Research Foundation 
Address  9/1, Kinkine Kutir, Vasant Nagar, Nagpur 
Type of Sponsor  Research institution 
 
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 Manju Mamtani  Daga Memorial Womens Hospital  Out Patient Department of Obstetrics and Gynecology, Gandhibagh, C.A. Road, Nagpur
Nagpur
MAHARASHTRA 
9823350019

manjuhemant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Daga Memorial Womens Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women 18 to 50 years of age 
Patients  Pregnant Women,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. If the candidate woman has come to antenatal care before 20 weeks of gestation

2. Those who have consented 
 
ExclusionCriteria 
Details  1. If the candidate woman has come to antenatal care after 20 weeks of gestation

2. Those who have not consented 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantify the burden of GD in central India  At the time of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
biomarker-based incremental prediction of maternal and fetal outcomes over and beyond that based on clinical risk factors.  After 1 year 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
Final Enrollment numbers achieved (Total)= "1041"
Final Enrollment numbers achieved (India)="1041" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/05/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The pandemic of diabetes is increasing at an alarming rate worldwide. During pregnancy, there is heightened insulin resistance which leads to gestational diabetes (GD) which can revert to a normal state after delivery or continue as type 2 diabetes later in life. The prevalence of GD in Indian pregnant women has been reported to be very high (16%). GD is associated with several adverse outcomes for both the mother and the fetus. Early detection of GD forms a cornerstone of GD control. To that end, detection of serum or plasma biomarkers early during pregnancy is considered an important first step. However, given the wide array of biomarkers available that have varied accuracy of prediction, a cogent collection of the early markers of GD is still awaited, especially in India. The proposed work aims to bridge this knowledge gap and also provide an estimate of the prevalence of GD in central India. The proposed work will piggyback on the PRIME study, which is currently in the second year and will enroll a total of 3,000 pregnant women this year. Of these, we will enroll 1200-1500 pregnant women who will satisfy the inclusion and exclusion criteria. This study will exploit the enrolment opportunity provided by the PRIME study as well as the infrastructural capacity of the Lata Medical Research Foundation. It is expected that the proposed work will not only provide the research information but will also yield a rational approach to early detection and risk-stratification of pregnant women with regards to GD. The proposed work will also provide later opportunities for exciting genetic, epigenetic and other biomarker studies that are likely to provide interesting and novel insights into the pathogenesis of GD.

 
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