Endometrial Evaluation in Cases of Postmenopausal Bleeding

NCT ID: NCT03847415

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2019-10-31

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.

Conditions

Postmenopausal Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ultrasound

to evalute 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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

hysteroscopy; fractional currettage

Eligibility Criteria

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 .

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

mohamed reda

assisant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Reda, M.D

Role: CONTACT

mo.reda2011@yahoo.com

+201000769315

Ahmed Aref

Role: CONTACT

References

Goldstein SR. Modern evaluation of the endometrium. Obstet Gynecol. 2010 Jul;116(1):168-176. doi: 10.1097/AOG.0b013e3181dfd557.

Reference Type: BACKGROUND

PMID: 20567184 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21147030 (View on PubMed)

Other Identifiers

endometrial volume

Identifier Type: -

Identifier Source: org_study_id