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Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Primary Purpose

Abnormal Uterine Bleeding

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Transvaginal sonography

About this trial

This is an interventional diagnostic trial for Abnormal Uterine Bleeding focused on measuring Transvaginal sonography, Endometrial thickness, Endometrial pattern, Abnormal uterine bleeding, Endometrial hyperplasia, Endometrial cancer

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Transvaginal sonography

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01786798

First Posted

February 6, 2013

Last Updated

February 9, 2016

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT01786798

Brief Title

Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chulalongkorn University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abnormal Uterine Bleeding

Keywords

Transvaginal sonography, Endometrial thickness, Endometrial pattern, Abnormal uterine bleeding, Endometrial hyperplasia, Endometrial cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transvaginal sonography

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Transvaginal sonography

Intervention Description

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

Primary Outcome Measure Information:

Title

The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.

Description

Time Frame

14 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

14 months

Other Pre-specified Outcome Measures:

Title

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

Time Frame

14 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Porntip Sirayapiwat, MD, MSc

Phone

662-256-4241

p_siraya@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Porntip Sirayapiwat, MD, MSc

Organizational Affiliation

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University 1873 Rama 4 Road, Patumwan, Bangkok, 10330, Thailand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Porntip Sirayapiwat, MD, MSc

Phone

662-256-4241

p_siraya@hotmail.com

First Name & Middle Initial & Last Name & Degree

Porntip Sirayapiwat, MD,MSc

12. IPD Sharing Statement

Citations:

PubMed Identifier

19921229

Citation

Ozdemir S, Celik C, Gezginc K, Kiresi D, Esen H. Evaluation of endometrial thickness with transvaginal ultrasonography and histopathology in premenopausal women with abnormal vaginal bleeding. Arch Gynecol Obstet. 2010 Oct;282(4):395-9. doi: 10.1007/s00404-009-1290-y. Epub 2009 Nov 17.

Results Reference

result

PubMed Identifier

17100821

Citation

Getpook C, Wattanakumtornkul S. Endometrial thickness screening in premenopausal women with abnormal uterine bleeding. J Obstet Gynaecol Res. 2006 Dec;32(6):588-92. doi: 10.1111/j.1447-0756.2006.00455.x.

Results Reference

result

PubMed Identifier

11437723

Citation

Dueholm M, Jensen ML, Laursen H, Kracht P. Can the endometrial thickness as measured by trans-vaginal sonography be used to exclude polyps or hyperplasia in pre-menopausal patients with abnormal uterine bleeding? Acta Obstet Gynecol Scand. 2001 Jul;80(7):645-51.

Results Reference

result

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Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

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