Endometrial Evaluation in Cases of Postmenopausal Bleeding

Postmenopausal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03847415
• Other study ID #: endometrial volume
• Status: Not yet recruiting
• Start date: February 2019
• Est. completion date: October 2019

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: Mohamed Reda, M.D
• Phone: +201000769315
• Email: mo.reda2011[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Gender: Female
• Age group: 45 Years and older

Eligibility

• 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 .

Related Conditions & MeSH terms

• Hemorrhage
• Postmenopausal Bleeding
• Uterine Hemorrhage

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Goldstein SR. Modern evaluation of the endometrium. Obstet Gynecol. 2010 Jul;116(1):168-76. doi: 10.1097/AOG.0b013e3181dfd557. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	comparison between hysteroscopy and ultrasound in post menopausal bleeding	to compare hysteroscopy with ultrasound	6months