Clinical trial NCT03847415: Endometrial Evaluation in Cases of Postmenopausal Bleeding
Official title: Endometrial Evaluation in Cases of Postmenopausal Bleeding Using Three Dimensional Ultrasound , Power Doppler Angiography and Office Hysteroscopy in Correlation to Pathological Findings .
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postmenopausal Bleeding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women Age \> 45 years postmenopausal uterine bleeding

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.

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 .

Primary outcomes:
measure: accuracy of 3d ultrasound in post menopausal bleeding
timeFrame: 6months
Secondary outcomes:
measure: comparison between hysteroscopy and ultrasound in post menopausal bleeding
timeFrame: 6months
Other outcomes:
Locations:
Study officials:
References:
citation: Goldstein SR. Modern evaluation of the endometrium. Obstet Gynecol. 2010 Jul;116(1):168-176. doi: 10.1097/AOG.0b013e3181dfd557.
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.