Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01786798

Enrollment

560

Registered

2013-02-08

Start date

2013-02-28

Completion date

2016-12-31

Last updated

2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Uterine Bleeding

Keywords

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

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.

Interventions

DEVICETransvaginal sonography

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.	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

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

Measure	Time frame
To study the prevalence of the various causes of abnormal uterine bleeding in premenopausal women aged more than 35	14 months

Countries

Thailand

Contacts

Primary ContactPorntip Sirayapiwat, MD, MSc

p_siraya@hotmail.com662-256-4241

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026