Endometrial Evaluation in Cases of Postmenopausal Bleeding

Endometrial Evaluation in Cases of Postmenopausal Bleeding Using Three Dimensional Ultrasound , Power Doppler Angiography and Office Hysteroscopy in Correlation to Pathological Findings .

The aim of this prospective observational study is to evaluate abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy

Study Overview

• Status: Unknown
• Conditions: Postmenopausal Bleeding
• Intervention / Treatment: Diagnostic test: ultrasound

Detailed Description

Postmenopausal bleeding (PMB) is defined as vaginal bleeding occurring after twelve months of amenorrhoea, in a woman of the age where the menopause can be expected. Hence it does not apply to a young woman, who has had amenorrhoea from anorexia nervosa, or a pregnancy followed by lactation. However, it can apply to younger women following premature ovarian failure or premature menopause, Postmenopausal bleeding is a common problem representing 5% of all gynaecology outpatient attendances. postmenopausal bleeding is usually the first symptom of endometrial cancer and active intervention can lead to its early detection. So, there is need of a diagnostic tool with high accuracy for detection of endometrial pathology in most efficient and least invasive method possible.

Endometrial sampling is the gold standard for diagnosing abnormalities in the endometrial tissues ,however . There is a growing trend to use noninvasive procedures such as TVS, to measure the endometrial thickness, diagnose adenomyosis, endometrial polyps .Another important ability of 3D TVS is volume calculation using the Virtual Organ Computer-aided AnaLysis (VOCAL) even in irregularly shaped structures. This method has been demonstrated to be more accurate than 2D-volume estimation .

• Hysteroscopy has the advantage of directly visualizing the uterine cavity and the endometrium, allowing biopsy to be taken immediately from the suspected abnormality.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women Age > 45 years postmenopausal uterine bleeding

Description

• Inclusion Criteria:
• Women Age > 45 years
• with postmenopausal uterine bleeding

Exclusion Criteria:

• Women with bleeding disorders or coagulopathy
• women with cervical cancer or breast carcinoma .
• history of tamoxifen intake
• women with fibroid .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of 3d ultrasound in post menopausal bleeding	to evalute women with postmenpausal uterine bleeding using three dimensional ultrasound assessment of endometrial volume	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison between hysteroscopy and ultrasound in post menopausal bleeding	to compare hysteroscopy with ultrasound	6months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Goldstein SR. Modern evaluation of the endometrium. Obstet Gynecol. 2010 Jul;116(1):168-176. doi: 10.1097/AOG.0b013e3181dfd557.
• Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol. 2011 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: February 9, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (ACTUAL): February 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: endometrial volume

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No