Vocal in Assessment of Endometrium in Postmenopause

Postmenopausal Bleeding Clinical Trial

Official title:

The Relation Between Endometrial Volume by 3D Vocal Ultrasound and Histopathology in Women With Postmenopausal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404154
• Other study ID #: vocal
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: August 25, 2018

Study information

• Verified date: October 2018
• Source: Aljazeera Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding

Description:

Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non invasive methods as Transvaginal ultrasound with 3 D application using different softwares .

One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ Computer aided Analysis ) that can measure volume especially in tissues with irregular borders And this technology is considered to be superior than the conventional 2 D ultrasound . .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 25, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

-Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Exclusion Criteria:

• Women with hormone replacement therapy.

• Women showing intra-cavitary fluid collection at ultrasound examination

• Women with other gynecological lesions in the pelvis other than the uterus

• Previous diagnosis of endometrial pathology.

Related Conditions & MeSH terms

• Hemorrhage
• Postmenopausal Bleeding
• Uterine Hemorrhage

Intervention

Diagnostic Test:
• 3D ultrasound
it describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding

Procedure:
• Dilatation and curretage
it describes the surgical maneuver that will be made to diagnose cause of bleeding

Locations

Country	Name	City	State
Egypt	Algazeerah	Giza

Sponsors (4)

Lead Sponsor	Collaborator
Aljazeera Hospital	Kasr El Aini Hospital, National Research Center, Egypt, om almasreen hospital ,Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma	it describes how many women will be properly diagnosed with carcinoma	within 4 weeks