Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Not Applicable

• Conditions: Abnormal Uterine Bleeding
• Interventions: Device: Transvaginal sonography

• Registration Number: NCT01786798
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 560

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvaginal sonography	Transvaginal sonography	-

Primary Outcome Measures

Name	Time	Method
The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.	14 months	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: 1. Triple-layer appearance; 2. Mixed echogenic pattern; 3. Hyper-echogenic pattern

Secondary Outcome Measures

Name	Time	Method
To identify the cut-off points of endometrial thickness that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer.	14 months	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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand