Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding

Postmenopausal Bleeding Clinical Trial

Official title:

The Role of Office Hysteroscopy and Endometrial Power Doppler Using the International Endometrial Tumor Analysis Group Classification in the Evaluation of Postmenopausal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488798
• Other study ID #: 62014
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: June 30, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis.

Description:

The aim was to compare the efficiency of the upper mentioned interventions in diagnosing the cause of postmenopausal bleeding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 47 Years to 64 Years

Eligibility

Inclusion Criteria:

• 100 patients complaining of postmenopausal bleeding. Postmenopausal bleeding was defined as vaginal bleeding that occurred after at least 12 months of amenorrhea.

Exclusion Criteria:

• Exclusion criteria included any history of hormone administration in the last 6 months, any medical condition that might cause abnormal uterine bleeding like coagulation disorders, hypertension, cardiac disease, thyroid disorders or hepatic condition.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Postmenopausal Bleeding
• Uterine Hemorrhage

Intervention

Procedure:
• 2D grey scale vaginal ultrasound
To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).
• 3D power Doppler vaginal ultrasound
To assess the endometrium using the IETA group criteria.
• Office hysteroscopy
using the vaginoscopic approach to assess the uterine cavity and take sample.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding	Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding	1 week	No