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CTRI Number  CTRI/2025/09/094297 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Screening for diabetes in postpartum women with previous gestational diabetes mellitus : A one year prospective cohort study 
Scientific Title of Study   A one year prospective cohort study of screening for diabetes mellitus among postpartum women with gestational diabetes mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Guntaka Tejaswi Reddy 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8466991177  
Fax    
Email  tejaswi.guntaka66@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Kamal Patil 
Designation  Professor, OBST & Gynecology , JNMC  
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  GURUPRIYA,2nd Main, 2nd Cross, Sadashiv Nagar, Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  98455 65454  
Fax    
Email  kamalpatil1967@yahoo.co.in   
 
Details of Contact Person
Public Query
 
Name  Guntaka Tejaswi Reddy 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8466991177  
Fax    
Email  tejaswi.guntaka66@gmail.com  
 
Source of Monetary or Material Support  
Dr.KLE’s Prabhakar Kore hospital  
 
Primary Sponsor  
Name  Guntaka Tejaswi Reddy 
Address  Jawaharlal Nehru Medical College,Belagavi-590010,Karnataka,India 
Type of Sponsor  Other [SELF] 
 
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 
DrGuntaka Tejaswi Reddy  KLES Dr Prabhakar Kore Hospital and Medical Research Centre,JNMC Belagavi  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi
Belgaum
KARNATAKA 
8466991177

tejaswi.guntaka66@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications,  
 
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 with Gestational diabetes mellitus confirmed by the Diabetes In Pregnancy Study Group India /International Association of Diabetes in Pregnancy Study Group
Women delivered at KLE Dr. Prabhakar Kore Hospital
 
 
ExclusionCriteria 
Details  Overt diabetes mellitus patients
Pregnant women declined to participate
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To screen for diabetes mellitus among postpartum women with gestational diabetes mellitus  4 to 12 weeks postpartum 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the barriers to postpartum screening for diabetes mellitus in gestational diabetes mellitus patients   4 weeks to 12 weeks postpartum 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   07/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Introduction and Need for the study 

Gestational Diabetes Mellitus (GDM) is a common pregnancy-related metabolic disorder, affecting around 3.5% of pregnant women in Karnataka. It significantly increases the risk of adverse maternal and neonatal outcomes, including preeclampsia, macrosomia, and neonatal hypoglycemia. Women with GDM have up to a 6.35-fold higher risk of developing Type 2 Diabetes Mellitus later in life. GDM is also linked to long-term complications such as metabolic syndrome and cardiovascular disease. However, postpartum screening for glucose intolerance remains inadequate due to systemic and patient-related challenges.

Despite guideline recommendations for postpartum screening between 4–12 weeks, adherence remains low in India due to cultural, economic, and logistical barriers. Many women miss follow-up visits, limiting early detection of persistent glucose intolerance and T2DM. Current research lacks data on how breastfeeding, physical activity, and psychosocial health influence glycemic outcomes. There’s also limited representation from rural and diverse socioeconomic groups. This study aims to address these gaps and inform targeted strategies for postpartum diabetes prevention.

Data collection procedure
Informed consent will be taken after screening for eligibility. 
In total, enrolled study participants between 2 to 5 days after delivery fasting blood sample of 2ml venous blood is taken, and between 4 to 12 weeks postpartum, are instructed to fast for at least 8 hours before the test. A fasting blood sample of 2 mL venous blood is taken under aseptic conditions, and after that, 75 grams of glucose dissolved in water must be consumed within 5 minutes. 
After the glucose drink, blood samples are collected at specific intervals to measure the response of the body to the glucose. 
The intervals include 1 hour after drinking the glucose solution and 2 hours after drinking the glucose solution.

 





 
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