| 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
|
|
|
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
|
|
|
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. |