Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

C

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)

560 participants in 1 patient group

Transvaginal sonography
Other group
Treatment:
Device: Transvaginal sonography

Trial contacts and locations

1

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Central trial contact

Porntip Sirayapiwat, MD, MSc

Data sourced from clinicaltrials.gov

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