| CTRI Number |
CTRI/2025/12/098391 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Use of fibroscan as a safe diagnostic tool on women diagnosed to have type 1 diabetes in 1st trimester of pregnancy for early diagnosis of liver diseases |
|
Scientific Title of Study
|
Assessment of liver stiffness by fibroscan in pregnant women of 1st trimester with pre gestational diabetes mellitus without known hepatic pathology for early diagnosis of liver disorders |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aadrita Bishnu |
| Designation |
Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Rc hostel, Jawaharlal Nehru medical College, Belagavi
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7002801460 |
| Fax |
|
| Email |
aadrita280505@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aadrita Bishnu |
| Designation |
Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Rc hostel, Jawaharlal Nehru medical College, Belagavi
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7002801460 |
| Fax |
|
| Email |
aadrita280505@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aadrita Bishnu |
| Designation |
Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Rc hostel, Jawaharlal Nehru medical College, Belagavi
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7002801460 |
| Fax |
|
| Email |
aadrita280505@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of medical research-monetary support |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR
Indian Council of Medical Research
V.Ramalingaswami Bhavan , P O box 4911, Ansari nagar, New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Farzana Begaum Dharwad |
KLE Dr. Prabhakar Kore Charitable Hospital |
KLE Dr. Prabhakar Kore Charitable Hospital, Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
99869 42518
farznaaz2006@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: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women in first trimester with pre gestational diabetes
mellitus |
|
| ExclusionCriteria |
| Details |
Patients with known hepatic pathology like chronic liver
diseases, liver cirrhosis, auto immune hepatitis, hepatocellular carcinoma etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observation of fibroscan results of pregnant women with pre gestational diabetes mellitus(PGDM) without known hepatic pathology in the first trimester of pregnancy for early diagnosis o liver diseases and prompt referral. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fetal and maternal outcomes followup and reduction of maternal and perinatal mortality and morbidity due to liver disorders in pregnancy. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
13/12/2025 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is an observational study using convenient sampling technique to observe the results of fibroscan on pre gestational diabetic women of 1st trimester without any known hepatic pathology. This study aims to assess the liver stiffness and its relation with insulin resistance using fibroscan as a non invasive diagnostic tool . The fetal and maternal outcomes will be studied and effects of altered fibroscan results on them.The first change that occurs in pregnant individuals with pre gestational diabetes mellitus is fall in fasting glucose levels , followed by insulin resistance and glucose intolerance potentially causing liver derived metabolic complications , complications like pre eclampsia, preterm birth and affect both fetal and maternal health. Fibroscan is a diagnostic modality that uses transient elastography which has 10 times smaller sampling error (3%) and better inter observer reliability in contrast to liver biopsy. The study will be conducted on pregnant women with pre gestational diabetes mellitus(PGDM) without known hepatic pathology in the first trimester of pregnancy attending the antenatal opd and wards of a tertiary health care centre. Since there is limited longitudinal data , further research is required to determine the specific contribution of insulin resistance to liver stiffness. This study aims to study the risk posed by pre gestational diabetes mellitus in development and progression of liver disease in pregnant woman with emphasis on the potential role of fibroscan for early detetction of steatosis/ fibrosis in pregnancies complicated by pregestational diabetes mellitus.
|