- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02488798
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding
The Role of Office Hysteroscopy and Endometrial Power Doppler Using the International Endometrial Tumor Analysis Group Classification in the Evaluation of Postmenopausal Bleeding
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
postmenopausal bleeding group
100 women with postmenopausal bleeding undergoing 2D greyscale vaginal ultrasound and 3D Endometrial power Doppler and the features were classified using six different vascular patterns described by IETA group including the following patterns; single dominant vessel without branching, with branching, multiple vessels with focal origin, with multifocal origin at the myometrium-endometrium junction, scattered vessels or circular flow (Kucur et al., 2013 ). All patients then had Office hysteroscopy carried out in the outpatient clinic using vaginoscopic approach (Cooper et al., 2010). With endometrial samples from lesions or from the cavity for histopathological analysis. |
To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).
To assess the endometrium using the IETA group criteria.
using the vaginoscopic approach to assess the uterine cavity and take sample.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding
Time Frame: 1 week
|
Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding
|
1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62014
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