Abnormal Uterine BleedingNCT01786798
Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding
A study testing Transvaginal sonography in people with Abnormal Uterine Bleeding, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Transvaginal sonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal women aged over than 35
- Abnormal uterine bleeding (menorrhagia/menometrorrhagia/metrorrhagia)
- Accept transvaginal examination (pelvic examination and ultrasound)
- Informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Porntip Sirayapiwat, MD, MSc, 662-256-4241, p_siraya@hotmail.com
Porntip Sirayapiwat, MD,MSc
About this study
Official title: Role of Transvaginal Ultrasonography in Evaluating Premenopausal Women Aged More Than 35 Years With Abnormal Uterine Bleeding
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.
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- Transvaginal sonography
- Keywords
- Transvaginal sonography, Endometrial thickness, Endometrial pattern, Abnormal uterine bleeding, Endometrial hyperplasia, Endometrial cancer
- Medical subject headings
- Metrorrhagia, Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal sonographyDevice
Transvaginal sonography will be performed to:
- measure the endometrial thickness
- detect the endometrial pattern
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal sonography | Other | Not described Receives: Device: Transvaginal sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.
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
Measured: 14 months
Secondary outcomes (1)
To identify the cut-off points of endometrial thickness that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer.
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.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Porntip Sirayapiwat, MD, MSc, Principal investigator, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University 1873 Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786798
- Sponsor's protocol ID
- RA55/34
- Status last verified
- Feb 2016
- First submitted
- 6 Feb 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19921229Getpook 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.
PubMed 17100821Dueholm 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.
PubMed 11437723
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transvaginal Ultrasonography in Evaluating Premenopausal Women Aged More Than 35 Years With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT01786798
- Acronym / sponsor ID
- RA55/34
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- Transvaginal sonography, Endometrial thickness, Endometrial pattern, Abnormal uterine bleeding, Endometrial hyperplasia, Endometrial cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal sonography | Other | Device: Transvaginal sonography |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Premenopausal women aged over than 35
- Abnormal uterine bleeding (menorrhagia/menometrorrhagia/metrorrhagia)
- Accept transvaginal examination (pelvic examination and ultrasound)
- Informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal sonographyTransvaginal sonography will be performed to: * measure the endometrial thickness * detect the endometrial pattern | Device | Transvaginal sonography |
Primary outcome
The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.
Time frame: 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
1 secondary outcome
To identify the cut-off points of endometrial thickness that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer.
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Results publication: PubMed 19921229Ozdemir 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.
- Results publication: PubMed 17100821Getpook 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.
- Results publication: PubMed 11437723Dueholm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Porntip Sirayapiwat, MD, MSc principal investigator
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University 1873 Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal sonography in people with Abnormal Uterine Bleeding, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Porntip Sirayapiwat, MD, MSc (662-256-4241, p_siraya@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer. (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01786798, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.