Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Sponsor

Chulalongkorn University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01786798

Collaborator

(none)

560

Enrollment

Location

Arm

Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abnormal Uterine Bleeding	Device: Transvaginal sonography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

560 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Transvaginal sonography	Device: Transvaginal sonography Transvaginal sonography will be performed to: measure the endometrial thickness detect the endometrial pattern

Arm

Intervention/Treatment

Other: Transvaginal sonography

Device: Transvaginal sonography

Transvaginal sonography will be performed to: measure the endometrial thickness detect the endometrial pattern

Outcome Measures

Primary Outcome Measures

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: Triple-layer appearance Mixed echogenic pattern Hyper-echogenic pattern

Secondary Outcome Measures

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.

Other Outcome Measures

To study the prevalence of the various causes of abnormal uterine bleeding in premenopausal women aged more than 35 [14 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University	Bangkok		Thailand	10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator: Porntip Sirayapiwat, MD, MSc, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University 1873 Rama 4 Road, Patumwan, Bangkok, 10330, Thailand