Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Study Overview
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Brief Summary
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The objective of this study is to investigate the role of transvaginal ultrasound in detecting endometrial hyperplasia and endometrial cancer in women aged more than 35 presenting with abnormal uterine bleeding.

Official Title
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Role of Transvaginal Ultrasonography in Evaluating Premenopausal Women Aged More Than 35 Years With Abnormal Uterine Bleeding

Conditions
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Abnormal Uterine Bleeding

Intervention / Treatment
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* Device: Transvaginal sonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal women aged over than 35 Abnormal uterine bleeding (menorrhagia/menometrorrhagia/metrorrhagia) Accept transvaginal examination (pelvic examination and ultrasound) Informed consent Exclusion Criteria: Severe uterine bleeding resulting in unstable vital signs Pregnancy Current medications: anticoagulants, selective serotonin reuptake inhibitor (SSRI), antipsychotics, corticosteroids, hormones, herbs Intrauterine device Genital tract pathologies: infection, submucous myoma distorting uterine cavity Systemic diseases that may cause coagulopathies: Thyroid disease, liver disease, pituitary/ hypothalamus diseases Not able to retrieve endometrial tissue

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transvaginal sonography<br> | Device: Transvaginal sonography<br>* Transvaginal sonography will be performed to: measure the endometrial thickness detect the endometrial pattern<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer. | The endometrial thickness will be measured in millimeter, at the mid-sagittal plane of the uterus, near the uterine fundus. The measurement will be performed 3 times, from basal layer of the anterior to basal layer of the posterior wall of uterine cavity. The average value of 3 measurements will be used for statistical analysis. The endometrial patterns are categorized into 3 groups: Triple-layer appearance Mixed echogenic pattern Hyper-echogenic pattern | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the cut-off points of endometrial thickness that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer. | The results of endometrial thickness will be compared with the endometrial pathologies.The cut-off points of endometrial thickness, in millimeter, that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer will be analyzed using receiver operating characteristic (ROC) curve. | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transvaginal sonography, Endometrial thickness, Endometrial pattern, Abnormal uterine bleeding, Endometrial hyperplasia, Endometrial cancer