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Clinical Trials/CTRI/2025/05/086381
CTRI/2025/05/086381
Not yet recruiting
Not Applicable

utility of transvaginal ultrasonography in detecting endometrial hyperplasia in premenopausal and postmenopausal women

DrRevathi1 site in 1 country100 target enrollmentStarted: May 17, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
DrRevathi
Enrollment
100
Locations
1
Primary Endpoint
Diagnostic Accuracy of TVUS for Endometrial Hyperplasia

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
35.00 Year(s) to 80.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Pregnancy or suspected pregnancy
  • Known or suspected endometrial cancer
  • Previous hysterectomy or endometrial ablation
  • Current or recent (within 6 months) use of hormone replacement therapy (HRT)
  • History of pelvic radiation therapy
  • Inability to undergo TVUS examination due to medical or physical limitations
  • Known allergy to ultrasound gel or other materials used during TVUS examination.

Outcomes

Primary Outcomes

Diagnostic Accuracy of TVUS for Endometrial Hyperplasia

Time Frame: 4 WEEKS AND 8 WEEKS.

The main outcome is assessing how accurately transvaginal ultrasonography (TVUS) can detect endometrial hyperplasia in premenopausal and postmenopausal women.

Time Frame: 4 WEEKS AND 8 WEEKS.

Secondary Outcomes

  • 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.)
  • TO KNOW THE THICKNESS(8 WEEKS)

Investigators

Sponsor
DrRevathi
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

dr srungavarapu revathi

shri b.m.patil medical college hospital and research centre

Study Sites (1)

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