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CTRI Number  CTRI/2018/04/013120 [Registered on: 09/04/2018] Trial Registered Prospectively
Last Modified On: 03/10/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To check for early diagnosing test for pregnancy diabetes and preterm birth  
Scientific Title of Study   Development of a Bio marker based test for Prediction of Gestational Diabetes Mellitus(GDM) and Preterm birth (PTB) 
Trial Acronym  GDM and PTB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kishore R Kumar  
Designation  Chief consultant neonatalogist and pediatrician  
Affiliation  Kids Clinic India private limited(Cloudnine Hospitals) 
Address  #1533, 9TH Main, 3rd Block, Jayanagar, Bangalore 560011 KARNATAKA

Bangalore
KARNATAKA
560011
India 
Phone  9900155001  
Fax    
Email  drkishore@cloudninecare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishore R Kumar  
Designation  Chief consultant neonatalogist and pediatrician  
Affiliation  Kids Clinic India private limited(Cloudnine Hospitals) 
Address  #1533, 9TH Main, 3rd Block, Jayanagar, Bangalore 560011 KARNATAKA

Bangalore
KARNATAKA
560011
India 
Phone  9900155001  
Fax    
Email  drkishore@cloudninecare.com  
 
Details of Contact Person
Public Query  
Name  Dr Kishore R Kumar  
Designation  Chief consultant neonatalogist and pediatrician  
Affiliation  Kids Clinic India private limited(Cloudnine Hospitals) 
Address  #1533, 9TH Main, 3rd Block, Jayanagar, Bangalore 560011 KARNATAKA

Bangalore
KARNATAKA
560011
India 
Phone  9900155001  
Fax    
Email  drkishore@cloudninecare.com  
 
Source of Monetary or Material Support  
Expenses involving Recruitment of patients, sampling of blood/plasma, urine samples, temporary storage for till collection to be taken care of by Cloudnine. Cost for downstream testing and assay development (Method development, LCMS bioanalysis and ELISA testing, Development of test kits, data analysis, interpretation etc.) to be borne by FNDR.  
 
Primary Sponsor  
Name  Cloudnine hospitals 
Address  #1533,9th main,3rd block, jayanagar,Bangalore-560011  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Foundation for Neglected Diseases Research FNDR  Sir M. Visvesvaraya Institute of Technology [MVIT], International Airport Road, Bangalore-562157.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kishore R kumar  Cloudnine Hospitals  Lab and consultant rooms Division: diagnostics #1533, 9TH Main, 3rd Block, Jayanagar, Bangalore 560011 KARNATAKA
Bangalore
KARNATAKA 		 9900155001

drkishore@cloudninecare.com 
Dr Kishore R kumar  Cloudnine Hospitals  Lab and consultant rooms Division: diagnostics No. 115, opposite Kemp fort(Total Mall), old airport road,, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA 		 9900155001

drkishore@cloudninecare.com 
Dr Kishore R kumar  Cloudnine Hospitals  Lab and consultant rooms Division: diagnostics No.47, 11th Main Road, Near MES Collage, Malleshwaram West, Bengaluru, Karnataka 560055
Bangalore
KARNATAKA 		 9900155001

drkishore@cloudninecare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gestational Diabetes Mellitus and Preterm birth 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Recruit women >18-40 years with clinically confirmed pregnancy, status healthy, no chronic disorder, HIV negative, no diabetes at enrollment and number of pregnancy <3. Recruitment up to max of 12 weeks of pregnancy. Recruit only those who commit to stay till delivery (stable population).  
 
ExclusionCriteria 
Details  Women <18 years or >40 years, HIV positives & Preexisting history of diabetes. Those deliver outside will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine ability and predictive value of biomarkers or combination of biomarkers to predict GDM and PTB early in first/second trimester vs GTT based diagnosis.   Outcome name: Biomarker signatures Time points : 9 months/ at the end of pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
Develop a diagnostic kit of biomarkers suitable for hospitals & point of care (POC) testing for field settings.  Outcome name : correlation of biomarkers with GTM Time points : 12 months.  
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   15/04/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

We plan to recruit ~300 pregnant women in early pregnancy and 50 healthy control women. Clinically confirmed pregnant women (by urine pregnancy test and/or by ultrasound scan) in 1st trimester of pregnancy (women maximum up to 3rd pregnancy), HIV negative, attending OPD of Cloudnine Care hospitals, Bangalore. Investigation methods, study protocols and patient consent forms have been approved by hospital ethics committee/IRB prior to beginning of study and enrolling the patients. 

Urine and blood samples will be collected at monthly intervals along with their complete medical check up and follow-ups throughout the pregnancy. GTT will be done at 24-28 week of pregnancy. The clinical samples will be tested for presence of biomarkers in validated tests/kit mentioned above. A correlation of biomarker data with GTT, BMI, obesity, GDM, clinical outcomes, preterm births (PTB), and post natal consequences will be analysed by using appropriate statistical tools. The predictive value of the proposed biomarkers/combinations to predict GDM and propensity to preterm birth will be determined.

 
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