Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Chulalongkorn University

Status: Unknown

Conditions: Abnormal Uterine Bleeding

Treatments: Device: Transvaginal sonography

Study type: Interventional

Funder types: Other

Identifiers

NCT01786798

RA55/34

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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560 participants in 1 patient group

Transvaginal sonography

Other group

Treatment:

Device: Transvaginal sonography