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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03351673
Other study ID # Endometrial volume
Secondary ID
Status Recruiting
Phase N/A
First received November 20, 2017
Last updated November 22, 2017
Start date August 8, 2017
Est. completion date August 2018

Study information

Verified date November 2017
Source Mansoura University
Contact Hanan Nabil, MD
Phone 002/01000571004
Email hanannobil00@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt mansoura University Mansourah Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology 1year
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