Back to resultsEndometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
Primary Purpose
Endometrial Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
endometrial volume 2D TVS
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Disorder
Eligibility Criteria
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
Sites / Locations
- mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endometrial volume 2D TVS
Arm Description
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
Outcomes
Primary Outcome Measures
accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology
Secondary Outcome Measures
Full Information
NCT ID
NCT03351673
First Posted
November 20, 2017
Last Updated
November 22, 2017
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT03351673
Brief Title
Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
Official Title
Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endometrial volume 2D TVS
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
endometrial volume 2D TVS
Intervention Description
calculation the endometrial volume using 2D ultrasound and correlation the results with the pathological findings of endometrial biopsy
Primary Outcome Measure Information:
Title
accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology
Time Frame
1year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan Nabil, MD
Phone
002/01000571004
Email
hanannobil00@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed Elrefaie, MD
Phone
002/01224515318
Email
wrefaie@yahoo.com
Facility Information:
Facility Name
mansoura University
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hanan nabil, MD
Phone
00201000571004
Email
hanannobil00@yahoo.com
First Name & Middle Initial & Last Name & Degree
waleed Elrefaie, MD
Phone
00201224515318
Email
wrefaie@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mahmoud Abdelrazik, MD
12. IPD Sharing Statement
Learn more about this trial
Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
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