Endometrial Evaluation in Cases of Postmenopausal Bleeding

• Conditions: Postmenopausal Bleeding

• Registration Number: NCT03847415
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Status Verified: 2019-02
• Study Start: 2019-02
• Study First Submitted: 2019-02-09
• Study First Submitted QC: 2019-02-18
• Last Update Submitted: 2019-02-18
• Study First Posted: 2019-02-20
• Last Update Posted: 2019-02-20
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
comparison between hysteroscopy and ultrasound in post menopausal bleeding	6months	to compare hysteroscopy with ultrasound