| 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
|
|
|
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
|
|
|
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.
|