| CTRI Number |
CTRI/2025/08/092166 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Can a Simple Sugar Test in Pregnancy Predict Future Complications for Mother and Baby? – A Study on the 3-Hour Glucose Tolerance Test |
|
Scientific Title of Study
|
Critical evaluation of 3 hour GTT in predicting adverse pregnancy outcomes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshaya Suresh |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBSTETRICS AND GYNAECOLOGY, Kasturba Medical College, Manipa, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
6379080723 |
| Fax |
|
| Email |
akshayasuresh1214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shripad Hebbar |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College |
| Address |
Department of OBSTETRICS AND GYNAECOLOGY, Kasturba Medical College, Manipa, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9611786463 |
| Fax |
|
| Email |
drshripadhebbar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shripad Hebbar |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College |
| Address |
Department of OBSTETRICS AND GYNAECOLOGY, Kasturba Medical College, Manipa, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9611786463 |
| Fax |
|
| Email |
drshripadhebbar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Akshaya Suresh |
| Address |
Junior Resident, Department of OBSTETRICS AND GYNAECOLOGY, Kasturba Medical College, Manipa, Manipal Academy of Higher Education, Manipal, Udupi, 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 Akshaya Suresh |
Kasturba Medical College, Manipal |
Department of OBSTETRICS AND GYNAECOLOGY, Women and Child block, Kasturba Medical College, Manipa, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
6379080723
akshayasuresh1214@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women aged 18 years and above attending antenatal care,
Singleton pregnancy confirmed by ultrasound,
Gestational age between 24 to 28 weeks,
Undergoing 3-hour OGTT as a routine antenatal screening |
|
| ExclusionCriteria |
| Details |
Multiple gestations, Maternal age below 18, Pre-existing Diabetes Mellitus, Inability to provide informed consent or participate in follow-up assessments,Gestational age outside the range of 24 to 28 weeks at the time of GTT, known Chronic kidney disease, Cushing’s syndrome, Uncontrolled thyroid disorders, Plan to deliver outside the study centre |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the diagnostic accuracy of 3-hour GTT in identifying Gestational Diabetes Mellitus, To evaluate association between abnormal 3hour GTT results and adverse pregnancy outcomes such
as Macrosomia, preterm birth, preeclampsia, caesarean delivery, To compare the pregnancy outcomes of women to normal OGTT results to those of abnormal results, To investigate maternal characteristics (e.g.- BMI, Family history) that may influence 3-hour GTT and adverse pregnancy outcomes, To explore neonatal outcomes such as NICU admission, Respiratory distress in relation to maternal GTT results |
To assess the diagnostic accuracy of 3-hour GTT in identifying Gestational Diabetes Mellitus, To evaluate association between abnormal 3hour GTT results and adverse pregnancy outcomes such
as Macrosomia, preterm birth, preeclampsia, caesarean delivery, To compare the pregnancy outcomes of women to normal OGTT results to those of abnormal results, To investigate maternal characteristics (e.g.- BMI, Family history) that may influence 3-hour GTT and adverse pregnancy outcomes, To explore neonatal outcomes such as NICU admission, Respiratory distress in relation to maternal GTT results |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="223"
Sample Size from India="223"
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)
|
12/08/2025 |
| 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="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
|
Recruitment and Enrolment-Eligible participants will be identified during routine antenatal visits between 24 and 28 weeks of gestation. They will be provided with detailed information about the study, including its purpose, procedures, risks, and benefits. Written informed consent will be obtained from those who agree to participate, Baseline Data Collection-At enrolment, the following baseline information will be recorded using a structured questionnaire and medical records. Maternal demographic data (age, parity,). Medical and obstetric history (previous GDM, hypertension, etc.), Family history of diabetes, Body mass index (BMI), Blood pressure, Any concurrent medications or comorbidities, 3-Hour OGTT Procedure-Participants will be instructed to fast overnight (8–12 hours). On arrival, a fasting venous blood sample will be collected. Participants will then consume a 75g glucose solution(depending on national guidelines). Blood samples will be drawn at 1 hour, 2 hours, after glucose intake. All samples will be analysed using standardized laboratory methods to ensure consistency. Antenatal Follow-up-Participants will continue with routine antenatal visits. Study investigators will monitor: -Compliance with GDM management. Any maternal complications (e.g., preeclampsia, polyhydramnios, infections). Ultrasound findings (fetal growth, amniotic fluid index, etc.). Delivery and Outcome Data Collection. At delivery, data will be collected from hospital records including: Mode of delivery (normal, assisted, caesarean). Gestational age at delivery. Maternal complications during labour and postpartum
|