| CTRI Number |
CTRI/2025/05/086381 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
utility of transvaginal ultrasonography in detecting endometrial hyperplasia in premenopausal and postmenopausal women |
|
Scientific Title of Study
|
utility of transvaginal ultrasonography in detecting endometrial hyperplasia in premenopausal and postmenopausal women |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr srungavarapu revathi |
| Designation |
junior resident (PG) |
| Affiliation |
shri b.m.patil medical college hospital and research centre |
| Address |
opd no.2 ,shri b.m.patil medical college hospital and research centre, bangaramma sajjan campus,vijayapura. karnataka 586103 india bijapur karnataka 586103 india
Bijapur
KARNATAKA
586103
India |
| Phone |
9704471225 |
| Fax |
|
| Email |
revathisrungavarapu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.s.r bidri |
| Designation |
professor |
| Affiliation |
shri b.m.patil medical college hospital and research centre |
| Address |
opd no 2 shri b.m.patil medical college hospital and research centre,bangaramma sajjan campus,vijayapura bijapur karnataka 586103 india
Bijapur
KARNATAKA
586103
India |
| Phone |
9704471225 |
| Fax |
|
| Email |
drrevathichoudaryh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr srungavarapu revathi |
| Designation |
junior resident (PG) |
| Affiliation |
shri b.m.patil medical college hospital and research centre |
| Address |
OPD NO.2 ,shri b.m.patil medical collage hospital and research centre, bangaramma sajan campus,vijayapura. karnataka 586103 INDIA
Bijapur
KARNATAKA
586103
India |
| Phone |
9704471225 |
| Fax |
|
| Email |
revathisrungavarapu@gmail.com |
|
|
Source of Monetary or Material Support
|
| opd no 2 shri bm patil medical collage hospital and research centre,shri bangaramma sajjan campus, vijayapura,586103. |
|
|
Primary Sponsor
|
| Name |
DrRevathi |
| Address |
opd no 2 shri b.m.patil medical college hospital and research centre, bangaramma sajjan campus,vijayapura bijapur karnataka 586103 india |
| Type of Sponsor |
Other [self] |
|
|
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 srungavarapu revathi |
shri b.m.patil medical college hospital and research centre |
opd no.2 ,shri b.m.patil medical college hospital and research centre, bangaramma sajjan campus,vijayapura 586103
Bijapur
KARNATAKA |
9704471225
revathisrungavarapu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R935||Abnormal findings on diagnostic imaging of other abdominal regions, including retroperitoneum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL) |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Presence of symptoms suggestive of endometrial hyperplasia (e.g., abnormal uterine bleeding, pelvic pain) in Pre and post menopausal women who can undergo TVUS examination
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or suspected pregnancy
2. Known or suspected endometrial cancer
3. Previous hysterectomy or endometrial ablation
4. Current or recent (within 6 months) use of hormone replacement therapy (HRT)
5. History of pelvic radiation therapy
6. Inability to undergo TVUS examination due to medical or physical limitations
7. Known allergy to ultrasound gel or other materials used during TVUS examination
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Diagnostic Accuracy of TVUS for Endometrial Hyperplasia
The main outcome is assessing how accurately transvaginal ultrasonography (TVUS) can detect endometrial hyperplasia in premenopausal and postmenopausal women.
|
4 WEEKS AND 8 WEEKS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Optimal Endometrial Thickness Thresholds: Determining appropriate endometrial thickness cut-off values for diagnosing hyperplasia in both premenopausal and postmenopausal groups.
Morphological Patterns on TVUS: Identifying specific endometrial patterns (e.g., diffuse thickening or irregular contours) associated with hyperplasia, aiding in distinguishing between types of hyperplasia.
Recommendations for Further Testing: Evaluating when additional procedures, like biopsy or hysteroscopy, are warranted based on TVUS findings.
Utility Across Menopausal Status: Comparing TVUS diagnostic effectiveness between premenopausal and postmenopausal women, factoring in hormonal variations. |
In women aged 35-80 years |
| TO KNOW THE THICKNESS |
8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/05/2025 |
| 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 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
|
Transvaginal ultrasonography (TVUS) plays a significant role in diagnosing endometrial hyperplasia in pre- and post-menopause women.
- Accuracy: TVUS showed an accuracy of 88.25% in premenopause women and 100% in postmenopause women ¹. - Sensitivity and Specificity: The sensitivity and specificity of TVUS in diagnosing endometrial hyperplasia were 90.7% and 84% in premenopause women, respectively ¹. - Positive and Negative Predictive Values: The positive predictive value (PPV) and negative predictive value (NPV) of TVUS were 90.7% and 84% in premenopause women, respectively ¹.
TVUS is a valuable diagnostic tool for evaluating abnormal uterine bleeding (AUB) and detecting endometrial hyperplasia, particularly in postmenopause women ¹. The high accuracy and sensitivity of TVUS make it an essential screening method in gynecological practice.
Overall, TVUS is a reliable diagnostic tool for detecting endometrial hyperplasia in pre- and post-menopause women, especially when used in conjunction with other diagnostic methods. |