| CTRI Number |
CTRI/2024/07/070299 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation and early diagnosis of abnormal uterine bleeding in pre and perimenopausal women using Ultrasound |
|
Scientific Title of Study
|
Evaluation of Abnormal Uterine Bleeding using International Endometrial Tumor Analysis Model |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diya Ghoshal |
| Designation |
Junior resident |
| Affiliation |
Department of Obsteterics and gynaecology, Kasturba Medical College, MAHE |
| Address |
Department of Obsteterics and gynaecology, Kasturba Medical College, Manipal - 576104, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8308713406 |
| Fax |
|
| Email |
diya.ghoshal11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jyothi Shetty |
| Designation |
Professor & HOU |
| Affiliation |
Department of Obsteterics and gynaecology, Kasturba Medical College, MAHE |
| Address |
Dept. of Obsteterics and gynaecology, Kasturba Medical College, Manipal-576104, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845973697 |
| Fax |
|
| Email |
jyothi.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diya Ghoshal |
| Designation |
Junior Resident |
| Affiliation |
Department of Obsteterics and gynaecology, Kasturba Medical College, MAHE |
| Address |
Dept. Of Obsteterics and gynaecology, Kasturba Medical College, Manipal-576104, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8308713406 |
| Fax |
|
| Email |
diya.ghoshal11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. Of OBGY, Kasturba Medical College, Manipal, MAHE-576104, Karnataka, India |
|
|
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 Diya Ghoshal |
Kasturba Hospital, Manipal |
Department of Obsteterics and Gynaecology, Kasturba Medical College, Manipal-576104, Karnataka, India
Udupi
KARNATAKA |
8308713406
diya.ghoshal11@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
With abnormal uterine bleeding |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
premenopausal women presenting with abnormal uterine bleeding
Postmenopausal bleeding
women consenting to be a part of this study |
|
| ExclusionCriteria |
| Details |
1.) women under 30 years and above 75 years of age
2.) women presenting with features of leiomyoma
3.) women not consenting to be a part of the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to look at efficacy of using Ultrasound features of International Endometrial Tumour Analysis Guidelines in diagnosing abnormal endometrial pathologies (benign or malignant) in women with abnormal uterine bleeding |
6-8 weeks, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to reduce time taken for diagnosis for any endometrial pathology using USG features |
6-8 weeks, 2 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2024 |
| Date of Study Completion (India) |
01/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective study design, where we will assess women with Abnormal uterine bleeding by firstly taking their history, doing a TVS (transvaginal ultrasound) to look for the headings as mentioned under IETA Guidelines( endometrial thickness,echogenicity,vascularity ,EM junction, bright edge, intracavitary fluid, color doppler, endometrial midline appearence) and score accordingly. If there is a high score of 6 or more,we will be taking a biopsy and corelating with its histopathology findings after 2 weeks for accuracy of diagnosis. We will initiate the study only after receiving the approval IEC. Based on the existing literature on use of IETA guidelines in Ultrasound to assess Abnormal uterine bleeding-a proforma will be made and the study will be carried out |