Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding

NCT ID: NCT03351673

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2018-08-31

Brief Summary

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Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may be different and endometrial irregularities may exist. Many studies assessed endometrial volume measured by three-dimensional (3D) TVS as a predictor of malignancy in women with postmenopausal bleeding. To our knowledge there is no study assess endometrial volume measured by two dimension TVS in prediction of endometrial pathology, however it is cheap and available than 3D TVS.

Detailed Description

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Conditions

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Endometrial Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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endometrial volume 2D TVS

perimenopausal women who bleed are examined by 2D TVS and the calculated endometrial volume using a specific formula and followed by endometrial biopsy for correlation with the pathological findings

Group Type EXPERIMENTAL

endometrial volume 2D TVS

Intervention Type DIAGNOSTIC_TEST

calculation the endometrial volume using 2D ultrasound and correlation the results with the pathological findings of endometrial biopsy

Interventions

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endometrial volume 2D TVS

calculation the endometrial volume using 2D ultrasound and correlation the results with the pathological findings of endometrial biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\*perimenopausal women with abnormal bleeding e.g. menorrhagia, metrorrhagia and polymenorrhea.

Exclusion Criteria

\*general or local causes of bleeding, drug intake or recent hormonal contraception
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Hanan Nabil

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hanan Nabil, MD

Role: CONTACT

Phone: 002/01000571004

Email: [email protected]

Waleed Elrefaie, MD

Role: CONTACT

Phone: 002/01224515318

Email: [email protected]

Facility Contacts

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hanan nabil, MD

Role: primary

waleed Elrefaie, MD

Role: backup

Other Identifiers

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Endometrial volume

Identifier Type: -

Identifier Source: org_study_id