| CTRI Number |
CTRI/2025/09/094576 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound study of fetal organs in diabetic pregnancies and its impact on newborn |
|
Scientific Title of Study
|
Sonography of Fetal Abdominal viscera in Pregnancies with Diabetes Mellitus: A Cross – sectional study in Second and Third trimester and its correlation with perinatal outcome. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTanisha Agrawal |
| Designation |
Junior Resident, MS OBG |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of OBG, Kasturba Medical College, MAHE, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7013523717 |
| Fax |
|
| Email |
tanisha1.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAkhila Vasudeva |
| Designation |
Professor and Head Of unit - DFM, MD, DNB, FRCOG |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of OBG, Kasturba Medical College, MAHE, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9591614792 |
| Fax |
|
| Email |
akhila.vasudeva@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrTanisha Agrawal |
| Designation |
Junior Resident, MS OBG |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of OBG, Kasturba Medical College, MAHE, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7013523717 |
| Fax |
|
| Email |
tanisha1.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrTanisha Agrawal |
| Address |
Department of OBG, Kasturba Medical College, MAHE, Manipal |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrTanisha Agrawal |
Kasturba Hospital |
Department of OBG, Kasturba Medical College, MAHE,Madhav Nagar, Eshwar nagar, Manipal
Udupi
KARNATAKA |
7013523717
tanisha1.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Insitutional Ethics Committee |
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 |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
-Singleton pregnancies with diabetes who have understood and have given informed consent.
- Non- diabetic , uncomplicated pregnancies with same gestational age.
|
|
| ExclusionCriteria |
| Details |
Multi-fetal pregnancy Anomalous fetus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess fetal abdominal viscera in the second and third trimesters using ultrasound imaging among pregnancies with diabetes and equal number of gestational age- matched non-diabetic healthy pregnancies |
1. Mid trimester during anomaly scan at 18-22 weeks
2. First growth scan between 28+0 to 32+6 weeks
3. Second growth scan between 33+0 to 36+6 weeks
4. Term growth scan between 37+0 to 40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate the correlation between sonographic appearance of fetal abdominal viscera & perinatal outcomes in pregnancies with diabetes |
1.At the time of anomaly scan
2.After first growth scan
3.After second growth scan
4.At the time of term growth scan |
|
|
Target Sample Size
|
Total Sample Size="512"
Sample Size from India="512"
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)
|
25/09/2025 |
| 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="10"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To study the second and third trimester sonographic appearance of fetal abdominal viscera in pregnancy with Diabetes and to correlate with perinatal outcomes such as macrosomia, incidence of elective delivery, traumatic delivery , fetal congenital anomalies incidence, neonatal morbidity and mortality. |