| 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)â€: 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
|
|
|
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
|
|
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
|
|
|
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. |