| CTRI Number |
CTRI/2023/11/059858 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Identifying the risk of developing high sugar levels in later pregnancy through scan in early pregnancy |
|
Scientific Title of Study
|
Sonographic measurement of maternal adipose tissue thickness in first trimester and the risk of developing gestational diabetes mellitus in later pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMASREE DEVAGIRI |
| Designation |
Junior Resident |
| Affiliation |
KMC,MANIPAL |
| Address |
Women & Child health block, Department of Obstretics & Gynaecology, Kasturba Medical college ,Madhav nagar, Manipal, Karnataka , India
Udupi
KARNATAKA
576104
India |
| Phone |
6281970440 |
| Fax |
|
| Email |
umasreedevagiri1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaraman Nambiar |
| Designation |
Professor and HOU |
| Affiliation |
KMC, MANIPAL |
| Address |
Women & Child Heath block, Department of Obstretics and Gynaecology, Kasturba medical college, Madhav nagar, Manipal, Karnataka,India
Udupi
KARNATAKA
576104
India |
| Phone |
9845082923 |
| Fax |
|
| Email |
drram.nambiar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayaraman Nambiar |
| Designation |
Professor and HOU |
| Affiliation |
KMC, MANIPAL |
| Address |
Women & Child health block, Department of Obstretics & Gynaecology, Kasturba Medical college ,Madhav nagar, Manipal, Karnataka , India
Udupi
KARNATAKA
576104
India |
| Phone |
9845082923 |
| Fax |
|
| Email |
drram.nambiar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, Manipal, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College MANIPAL |
| Address |
Kasturba Medical College, Madhav nagar, Manipal, Karnataka,India |
| Type of Sponsor |
Private medical college |
|
|
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 Umasree Devagiri |
Kasturba medical college |
Women and child health block, Department of Obstretics & Gynaecology, Kasturba medical college, Madhav nagar, Manipal
Udupi
KARNATAKA |
6281970440
umasreedevagiri1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college & Kasturba Hospital, Institutional ethics committee-2( Student research) |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Pregnant women aged between 21-45years
2)Singleton pregnancies of 11-14weeks of gestation |
|
| ExclusionCriteria |
| Details |
1)Women aged <21 and > 46years
2)Pre existing diabetes
3)Twin pregnancies
4)Presence of any fetal abnormalities
5)Pre conceptional BMI >26 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positively diagnosed gestational diabetes mellitus patients will be assessed and correlated with their previously measured adipose tissue thickness during 1st Trimester and its risk being evaluated. |
Sonographic measurement of maternal adipose tissue thickness will be measured at the time of NT Scan(11-14weeks of gestation)
GTT is done during 2nd Trimester (preferably 24-28weeks of gestation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Positively diagnosed GDM patients will be assessed and correlated with their previously measured adipose tissue thickness during 1st Trimester and its risk being evaluated. |
During NT Scan and 2nd Trimester of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="601"
Sample Size from India="601"
Final Enrollment numbers achieved (Total)= "601"
Final Enrollment numbers achieved (India)="601" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/11/2023 |
| Date of Study Completion (India) |
10/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/05/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Eligible Pregnant women between 11-14weeks of gestation are recruited from OBG OPD during their routine antenatal checkup or during their in patient stay.RBS >200mg/dl or HBA1C >6.5% was described as overt diabetic and Patients with Pre existing type 1 or 2 DM ,and patients with increased pre-conceptional BMI (>26)are not eliglible for study. Detailed description of the study procedure will be explained to them and the willing and eligible participants will be recruited after Informed written consent. All the patients will undergo transabdominal sonographic measurements of subcutaneous and visceral adipose tissue during 11-14weeks of gestation. It was performed using a 3.5-5.5MHz TAS probe-(Philips ClearVue ultrasound system). Subcutaneous adipose tissue thickness is measured as maximum vertical distance from the skin line to edge of linea alba, immediately caudal to xiphoid tip. The visceral adipose tissue was measured from posterior edge of linea alba to anterior surface of liver. Three measurements were done and their mean value is obtained. All these Patients will be (Contacted through telephone) and followed up during 2nd trimester, and will undergo 75g OGTT between 24-28weeks of period of gestation. The test was done following a 12hour fast, with sampling at 1hour and two hours post load. Diagnostic criteria of GDM( IADPSG criteria): Fasting glucose>92mg/dl Postprandial 1hr>180mg/dl Postprandial 2hr>153mg/dl One or more abnormal values from the 75g OGTT are diagnosed as GDM. Positively diagnosed GDM and negatively diagnosed GDM patients will be differntiated into two groups and are compared with their previously measured adipose tissue thickness during 1st Trimester and its risk being evaluated.
|