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Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

This study is currently recruiting participants.
Verified February 2016 by Chulalongkorn University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01786798
First Posted: February 8, 2013
Last Update Posted: February 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chulalongkorn University
  Purpose
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 Intervention
Abnormal Uterine Bleeding Device: Transvaginal sonography

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer. [ Time Frame: 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:
  • To identify the cut-off points of endometrial thickness that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer. [ Time Frame: 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 [ Time Frame: 14 months ]

Estimated Enrollment: 560
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Transvaginal sonography Device: Transvaginal sonography

Transvaginal sonography will be performed to:

  • measure the endometrial thickness
  • detect the endometrial pattern

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786798


Contacts
Contact: Porntip Sirayapiwat, MD, MSc 662-256-4241 p_siraya@hotmail.com

Locations
Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Porntip Sirayapiwat, MD, MSc    662-256-4241    p_siraya@hotmail.com   
Principal Investigator: Porntip Sirayapiwat, MD,MSc         
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
  More Information

Publications:
Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01786798     History of Changes
Other Study ID Numbers: RA55/34
First Submitted: February 6, 2013
First Posted: February 8, 2013
Last Update Posted: February 10, 2016
Last Verified: February 2016

Keywords provided by Chulalongkorn University:
Transvaginal sonography
Endometrial thickness
Endometrial pattern
Abnormal uterine bleeding
Endometrial hyperplasia
Endometrial cancer

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female