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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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ClinicalTrials.gov Identifier: NCT03351673
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hanan Nabil, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Endometrial Disorder Diagnostic Test: endometrial volume 2D TVS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 8, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology [ Time Frame: 1year ]


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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351673


Contacts
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Contact: Hanan Nabil, MD 002/01000571004 hanannobil00@yahoo.com
Contact: Waleed Elrefaie, MD 002/01224515318 wrefaie@yahoo.com

Locations
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Egypt
mansoura University Recruiting
Mansourah, Dakahlia, Egypt, 35516
Contact: hanan nabil, MD    00201000571004    hanannobil00@yahoo.com   
Contact: waleed Elrefaie, MD    00201224515318    wrefaie@yahoo.com   
Sub-Investigator: Mahmoud Abdelrazik, MD         
Sponsors and Collaborators
Mansoura University

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Responsible Party: Hanan Nabil, Assistant Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT03351673     History of Changes
Other Study ID Numbers: Endometrial volume
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female