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


N/A
35 Years
N/A
Not Enrolling
Female
Abnormal Uterine Bleeding

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

14 months

Safety Issue:

Yes

Principal Investigator

Porntip Sirayapiwat, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University 1873 Rama 4 Road, Patumwan, Bangkok, 10330, Thailand

Authority:

Thailand: Ethical Committee

Study ID:

RA55/34

NCT ID:

NCT01786798

Start Date:

February 2013

Completion Date:

March 2014

Related Keywords:

  • Abnormal Uterine Bleeding
  • Transvaginal sonography
  • Endometrial thickness
  • Endometrial pattern
  • Abnormal uterine bleeding
  • Endometrial hyperplasia
  • Endometrial cancer
  • Hemorrhage
  • Uterine Hemorrhage

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