| CTRI Number |
CTRI/2026/04/107880 [Registered on: 08/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Using Fetal Abdominal Wall Thickness Measured by Sonography to predict Birth Weight in Pregnant Patients with Diabetes |
|
Scientific Title of Study
|
Correlating Fetal Abdominal Wall
Thickness Measured by Ultrasound with Birth Weight in Diabetic Mothers in 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 |
Priyanka Bhattacharya |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Mediical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Mediical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9108324568 |
| Fax |
|
| Email |
priyanka.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jayaraman Nambiar M |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Mediical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845082923 |
| Fax |
|
| Email |
drram.nambiar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Bhattacharya |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Mediical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Mediical College, Manipal
KARNATAKA
576104
India |
| Phone |
9108324568 |
| Fax |
|
| Email |
priyanka.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Udupi, Karnataka- 576104 |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 Priyanka Bhattacharya |
Kasturba Hospital, Manipal |
Department of Obstetrics and Gynaecology
Udupi
KARNATAKA |
9108324568
priyanka.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and 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: O992||Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant females within 18-40 years diagnosed with gestational diabetes or preexisting diabetes who can give understand and give informed consent |
|
| ExclusionCriteria |
| Details |
Multifetal pregnancies
Fetal congenital anomalies or major malformations.
Severe maternal conditions (e.g., hypertension, preeclampsia, significant cardiovascular disease).
Women unable understand and converse in Kannada/English/Hindi language |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of the study is to use sonographically measured abdominal wall thickness (AWT) to enhance the prediction of fetal macrosomia to reduce perinatal complications in diabetic pregnancies. |
At 34-36 weeks Period of gestation, and post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
18/04/2026 |
| 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="2"
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
|
After obtaining the IEC approval and CTRI approval, proposed study will be initiated by seeking informed consent by the study participants. All women will be divided into the following subgroups - Overt DM (Group 1), GDM on Diet (Group 2), GDM on OHA (Group 3), GDM on Insulin (Group 4), GDM on both OHA and insulin (Group 5). Fetal abdominal wall thickness will be measured between 34-36 weeks of gestation, estimated birth weight will be calculated by Hadlock’s formula sonographically and correlated with birth weight. The receiver operating characteristic ROC curve will be applied to assess performance of AWT as a predictor with evaluation of AUC, sensitivity, specificity. Two predictors AWT and EFW will be combined with multiple logistic regression. |