Clinical trial NCT01786798: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Abnormal Uterine Bleeding
Keywords: Transvaginal sonography
Endometrial thickness
Endometrial pattern
Abnormal uterine bleeding
Endometrial hyperplasia
Endometrial cancer
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 560
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.
timeFrame: 14 months
Secondary outcomes:
measure: To identify the cut-off points of endometrial thickness that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer.
timeFrame: 14 months
Other outcomes:
measure: To study the prevalence of the various causes of abnormal uterine bleeding in premenopausal women aged more than 35
timeFrame: 14 months
Locations:
city: Bangkok
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University 1873 Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
name: Porntip Sirayapiwat, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.