Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

NCT01786798 | Unknown

• 1 other identifier: RA55/34
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Uterine Bleeding

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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: 1. Triple-layer appearance 2. Mixed echogenic pattern 3. Hyper-echogenic pattern

  14 months

Secondary Outcomes (1)

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

  14 months

Other Outcomes (1)

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

  14 months

Study Arms (1)

Transvaginal sonography

OTHER

Device: Transvaginal sonography

Interventions

Transvaginal sonography DEVICE

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

Transvaginal sonography

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal women aged over than 35
• Abnormal uterine bleeding (menorrhagia/menometrorrhagia/metrorrhagia)
• Accept transvaginal examination (pelvic examination and ultrasound)
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

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

Bangkok, 10330, Thailand

RECRUITING

Related Publications (3)

• 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.

  PMID: 19921229 RESULT

• 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.

  PMID: 17100821 RESULT

• 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.

  PMID: 11437723 RESULT

MeSH Terms

Conditions

Metrorrhagia; Endometrial Hyperplasia; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Porntip Sirayapiwat, MD, MSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Porntip Sirayapiwat, MD, MSc

CONTACT

662-256-4241; p_siraya@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

TH (1)