NCT03351673

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 20, 2017

Last Update Submit

November 22, 2017

Conditions

Endometrial Disorder

Outcome Measures

Primary Outcomes (1)

  • accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology

    1year

Study Arms (1)

endometrial volume 2D TVS

EXPERIMENTAL

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

Interventions

endometrial volume 2D TVSDIAGNOSTIC_TEST

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

endometrial volume 2D TVS

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \*general or local causes of bleeding, drug intake or recent hormonal contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Central Study Contacts

Hanan Nabil, MD

CONTACT

002/01000571004hanannobil00@yahoo.com

Waleed Elrefaie, MD

CONTACT

002/01224515318wrefaie@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 24, 2017

Study Start

August 8, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

EG(1)