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Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

This study is not yet open for participant recruitment.
Verified February 2013 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01786798
First received: February 6, 2013
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   35 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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
Study First Received: February 6, 2013
Last Updated: February 18, 2013
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on May 19, 2013