Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

NCT ID: NCT01786798

Last Updated: 2016-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abnormal Uterine Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transvaginal sonography

Group Type OTHER

Transvaginal sonography

Intervention Type DEVICE

Transvaginal sonography will be performed to:

* measure the endometrial thickness
* detect the endometrial pattern

Interventions

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Transvaginal sonography

Transvaginal sonography will be performed to:

* measure the endometrial thickness
* detect the endometrial pattern

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Porntip Sirayapiwat, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Porntip Sirayapiwat, MD, MSc

Role: CONTACT

662-256-4241

Facility Contacts

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Porntip Sirayapiwat, MD, MSc

Role: primary

662-256-4241

References

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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.

Reference Type RESULT
PMID: 19921229 (View on PubMed)

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.

Reference Type RESULT
PMID: 17100821 (View on PubMed)

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.

Reference Type RESULT
PMID: 11437723 (View on PubMed)

Other Identifiers

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RA55/34

Identifier Type: -

Identifier Source: org_study_id

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