| CTRI Number |
CTRI/2022/08/044962 [Registered on: 26/08/2022] Trial Registered Prospectively |
| Last Modified On: |
25/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence Of GDM in Indian Women: Retrospective Study |
|
Scientific Title of Study
|
To study the prevalence of GDM and associated outcomes in women visiting Gupte
Hospital and Centre for Research in Reproduction and to evaluate the progression of gestational glucose
intolerance (GGI) during pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Gupte |
| Designation |
Director and Obstetrician gynecologist |
| Affiliation |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
Ground Floor, Obstetrics And Gynaecology Department
Gupte Hospital and Centre for Research in Reproduction
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
drsanjaygupte@guptehospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Gupte |
| Designation |
Director and Obstetrician gynecologist |
| Affiliation |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
Ground Floor, Obstetrics And Gynaecology Department
Gupte Hospital and Centre for Research in Reproduction
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
drsanjaygupte@guptehospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Gupte |
| Designation |
Director and Obstetrician gynecologist |
| Affiliation |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
Ground Floor, Obstetrics And Gynaecology Department
Gupte Hospital and Centre for Research in Reproduction
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
drsanjaygupte@guptehospital.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
904 Bhandarkar Rd Ganeshwadi Deccan Gymkhana Pune Maharashtra 411004 |
| 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 |
| Dr Sanjay Gupte |
Gupte Hospital and Centre for Research in Reproduction |
Obstetrics And Gynaecology Department, Obstetrics Division, Ground Floor
Pune
MAHARASHTRA |
9822030238
drsanjaygupte@guptehospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gupte hospital 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 |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women who had visited Gupte Hospital and Centre for Research in
Reproduction and given their consent to use their clinical data for the research purpose |
|
| ExclusionCriteria |
| Details |
1. Any condition that, in the opinion of the investigator, does not justify the
patient’s inclusion in the study.
2. Patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Gestation Diabetes Mellitus (GDM) and progression of Impaired Glucose Tolerance (IGT) in patients visiting Gupte
Hospital and Centre for Research in Reproduction. |
Pregnant women who visited hospital during June 2012 to March 2022 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distribution characteristics of GDM patients |
Antepartum |
| Pregnancy outcome |
Intrapartum |
| Maternal and neonatal outcomes |
Postpartum |
|
|
Target Sample Size
|
Total Sample Size="20232"
Sample Size from India="20232"
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)
|
01/09/2022 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gestational diabetes mellitus (GDM) is defined as glucose intolerance during pregnancy. GDM is the most common complication noted due to increased metabolic stress during pregnancy. The prevalence of GDM is increasing globally due to various genetic and lifestyle-related factors. The prevalence of GDM is 10-14.3% in India, which is higher than in western countries. GDM may leads to an increased risk of fetal and maternal complications. Screening for GDM will help prompt diagnosis and can avoid further complications associated with mother and fetus. It is reported that screening of GDM can be best done during the 24-28 th week of gestation as there is chances of increased insulin resistance during this period. The Diabetes in Pregnancy Study group India (DIPSI) recommends one-step procedure for diagnosis of GDM.The present study was planned to analyze the prevalence of GDM and associated outcomes in Indian pregnant women. |