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CTRI Number  CTRI/2024/10/074938 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Examining Diabetes medication use in women having diabetes during their pregnancy 
Scientific Title of Study   Prescription pattern analysis of antidiabetes therapy in gestational diabetes patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushma R 
Designation  Student 
Affiliation  manipal college of pharmaceutical sciences 
Address  Department of Pharmacy Practice, manipal college of pharmaceutical sciences, MAHE, Manipal, karnataka

Udupi
KARNATAKA
576104
India 
Phone  9148082447  
Fax    
Email  sushma.mcopsmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Prasanna Kumar 
Designation  Assistant Professor- SG 
Affiliation  manipal college of pharmaceutical sciences 
Address  Department of Pharmacy Practice, manipal college of pharmaceutical sciences, MAHE, Manipal, karnataka

Udupi
KARNATAKA
576104
India 
Phone  9886725129  
Fax    
Email  prasanna.shetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Sushma R 
Designation  Student 
Affiliation  manipal college of pharmaceutical sciences 
Address  Department of Pharmacy Practice, manipal college of pharmaceutical sciences, MAHE, Manipal, karnataka

Udupi
KARNATAKA
576104
India 
Phone  9148082447  
Fax    
Email  sushma.mcopsmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba college and hospital, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India- 576104 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Research institution and hospital 
 
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 
Sushma R  Kasturba Hospital  department of Obstetrics and Gynecology Division-Women and child Block, Department of Endocrinology Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9148082447

sushma.mcopsmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and kasturba hospital Institutional ethics committee-2(student research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women diagnosed with gestational diabetes.
Prescribed with any form of antidiabetic therapy (insulin and oral hypoglycemics) during pregnancy, and eligible for a switch to other antidiabetic medications based on predefined criteria for blood glucose control.
Participants at any stage of gestation during diagnosis.
Participants who provide informed consent to participate in the study

 
 
ExclusionCriteria 
Details  Preexisting type-1 and type-2 diabetes and used any antihyperglycemic medications prior to their diagnosis of GDM. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluating the change in blood glucose levels when treated with different antidiabetic medications  at baseline, 4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Observing HbA1c levels, frequency of hypoglycemia & the maternal & fetal outcomes.
The risk developed due to the antidiabetic treatment in gestational diabetic patients. 
at baseline 4weeks & 8weeks 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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="1"
Months="6"
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  

Eligible patients will be selected based on inclusion and exclusion criteria, and their data will be gathered through patient profile forms, treatment charts, and prescriptions. This includes information on the types and patterns of antidiabetic medications prescribed, frequency of dose changes, and reasons for adjustments. Incidence and details of hypoglycemic episodes will be recorded from patient self-reports and progress records. Maternal and fetal outcomes, such as weight gain, blood pressure, incidence of preeclampsia, birth weight, and gestational age at delivery, will be documented. Additionally, the cost of illness will be analyzed by collecting direct medical costs (medications, diagnostic tests, hospital visits), direct non-medical costs (transportation, medical supplies), and indirect costs (loss of income, caregiver support) from billing records, insurance claims, and patient surveys. Data will be collected at baseline, during each prenatal visit, and at the first postpartum visit to ensure comprehensive tracking of clinical outcomes and treatment costs.

 
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