Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Abnormal Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01786798
• Other study ID #: RA55/34
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2013
• Last updated: February 9, 2016
• Start date: February 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Chulalongkorn University
• Contact: Porntip Sirayapiwat, MD, MSc
• Phone: 662-256-4241
• Email: p_siraya[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Hemorrhage
• Uterine Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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): — View 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. — View Citation

Ozdemir S, Celik C, Gezginç 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/s0040 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To study the prevalence of the various causes of abnormal uterine bleeding in premenopausal women aged more than 35		14 months	No
Primary	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	14 months	Yes
Secondary	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.	14 months	Yes