| CTRI Number |
CTRI/2021/08/035697 [Registered on: 16/08/2021] Trial Registered Prospectively |
| Last Modified On: |
07/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk association between weight gain in pregnancy to development of diabetes mellitus during pregnancy |
|
Scientific Title of Study
|
Risk Association Between Gestational Weight Gain And Gestational Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pratibha Prasannan |
| Designation |
MBBS, MD Internal Medicine, Fellow Resident in Diabetology |
| Affiliation |
Kasturba Medical College |
| Address |
Endocrinology Department,
Kasturba Medical College,
Tiger Circle Road,
Manipal
Endocrinology Department,
Kasturba Medical College,
Tiger Circle Road,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8156967671 |
| Fax |
|
| Email |
drpratibha51342@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahana Shetty |
| Designation |
(MBBS, MD, DM Endocrine) HOD Endocrinology |
| Affiliation |
Kasturba Medical College |
| Address |
Endocrinology Department,
Kasturba Medical College,
Tiger Circle Road,
Manipal
Endocrinology Department,
Kasturba Medical College,
Tiger Circle Road,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9944745014 |
| Fax |
|
| Email |
sahana.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Prasannan |
| Designation |
MBBS, MD Internal Medicine, Fellow Resident in Diabetology |
| Affiliation |
Kasturba Medical College |
| Address |
Endocrinology Department,
Kasturba Medical College,
Tiger Circle Road,
Manipal
Endocrinology Department,
Kasturba Medical College,
Tiger Circle Road,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8156967671 |
| Fax |
|
| Email |
drpratibha51342@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Pratibha Prasannan |
| Address |
Endocrinology Department
KMC Hospital
Tiger Circle Road,
Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Pratibha Prasannan |
Kasturba Medical College, |
Endocrinology department,
Kasturba Medical College,
Tiger Circle Road,
Manipal - 576104
Udupi
KARNATAKA |
8156967671
drpratibha51342@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
- All pregnant women undergoing oral glucose tolerance in the second trimester
- Singleton pregnancy |
|
| ExclusionCriteria |
| Details |
- Pregnant woman with pre-existing diabetes
- Pregnant women on steroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| risk association between weight gain in pregnancy and gestational diabetes |
baseline (at point of recruitment) at 6th month of pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical risk factors associated with gestational diabetes |
baseline (at point of recruitment) at 6th month of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
16/08/2021 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All pregnant women in their 2nd trimester, reporting to KMC Manipal OBG department would be recruited for this study at the point of conduct of OGTT. It is an observational study where patient profile and details regarding the underlying health and family history would be collected. Details such as LMP, parity, habituations, other comorbidities and weight gain during pregnancy would be collected. Patient recruitment will only be conducted after patient consent and all details provided will remain confidential. Patient would be diagnosed with gestational diabetes mellitus (GDM) based on the oral glucose tolerance test (OGTT) results. Those diagnosed to have GDM would be taken as Cases and those with normal glucose tolerance with the OGTT will be taken as Controls. Total of 63 patients would be recruited. There is no intervention involved in this study. The data obtained will help us in making an analysis of weight gain and its associated risk of developing diabetes in pregnancy, in our Indian population and thus, to also study the clinical risk factors for gestational diabetes. |