Postmenopausal BleedingNCT03847415
Endometrial Evaluation in Cases of Postmenopausal Bleeding
An observational study of Postmenopausal Bleeding, run by Cairo University.
Trial summary
The aim of this prospective observational study is to evaluate abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- ultrasound
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Oct 2019
- Phase
- Observational
- 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 45 years and older
- Women only
- Adult, Older adult
Study population: Women Age > 45 years postmenopausal uterine bleeding
Who may be able to join
- Women Age > 45 years
- with postmenopausal uterine bleeding
Who cannot join
- Women with bleeding disorders or coagulopathy
- women with cervical cancer or breast carcinoma .
- history of tamoxifen intake
- women with fibroid .
Trial locations and contacts
No sites are listed yet.
Ahmed Aref contact
About this study
Official title: Endometrial Evaluation in Cases of Postmenopausal Bleeding Using Three Dimensional Ultrasound , Power Doppler Angiography and Office Hysteroscopy in Correlation to Pathological Findings .
The aim of this prospective observational study is to evaluate abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy
Read the detailed description
Postmenopausal bleeding (PMB) is defined as vaginal bleeding occurring after twelve months of amenorrhoea, in a woman of the age where the menopause can be expected. Hence it does not apply to a young woman, who has had amenorrhoea from anorexia nervosa, or a pregnancy followed by lactation. However, it can apply to younger women following premature ovarian failure or premature menopause, Postmenopausal bleeding is a common problem representing 5% of all gynaecology outpatient attendances. postmenopausal bleeding is usually the first symptom of endometrial cancer and active intervention can lead to its early detection. So, there is need of a diagnostic tool with high accuracy for detection of endometrial pathology in most efficient and least invasive method possible.
Endometrial sampling is the gold standard for diagnosing abnormalities in the endometrial tissues ,however . There is a growing trend to use noninvasive procedures such as TVS, to measure the endometrial thickness, diagnose adenomyosis, endometrial polyps .Another important ability of 3D TVS is volume calculation using the Virtual Organ Computer-aided AnaLysis (VOCAL) even in irregularly shaped structures. This method has been demonstrated to be more accurate than 2D-volume estimation .
- Hysteroscopy has the advantage of directly visualizing the uterine cavity and the endometrium, allowing biopsy to be taken immediately from the suspected abnormality.
- Conditions
- Postmenopausal Bleeding
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Also called hysteroscopy, fractional currettage
to evalute abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of 3d ultrasound in post menopausal bleeding
to evalute women with postmenpausal uterine bleeding using three dimensional ultrasound assessment of endometrial volume
Measured: 6months
Secondary outcomes (1)
comparison between hysteroscopy and ultrasound in post menopausal bleeding
to compare hysteroscopy with ultrasound
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study startFeb 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal BleedingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed reda, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847415
- Sponsor's protocol ID
- endometrial volume
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goldstein SR. Modern evaluation of the endometrium. Obstet Gynecol. 2010 Jul;116(1):168-176. doi: 10.1097/AOG.0b013e3181dfd557.
PubMed 20567184Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol. 2011 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10.
PubMed 21147030
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Evaluation in Cases of Postmenopausal Bleeding Using Three Dimensional Ultrasound , Power Doppler Angiography and Office Hysteroscopy in Correlation to Pathological Findings .
- ClinicalTrials.gov ID
- NCT03847415
- Acronym / sponsor ID
- endometrial volume
- Conditions
- Postmenopausal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 20 Feb 2019 (actual)
- 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 aim of this prospective observational study is to evaluate abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy
Detailed description
Postmenopausal bleeding (PMB) is defined as vaginal bleeding occurring after twelve months of amenorrhoea, in a woman of the age where the menopause can be expected. Hence it does not apply to a young woman, who has had amenorrhoea from anorexia nervosa, or a pregnancy followed by lactation. However, it can apply to younger women following premature ovarian failure or premature menopause, Postmenopausal bleeding is a common problem representing 5% of all gynaecology outpatient attendances. postmenopausal bleeding is usually the first symptom of endometrial cancer and active intervention can lead to its early detection. So, there is need of a diagnostic tool with high accuracy for detection of endometrial pathology in most efficient and least invasive method possible.
Endometrial sampling is the gold standard for diagnosing abnormalities in the endometrial tissues ,however . There is a growing trend to use noninvasive procedures such as TVS, to measure the endometrial thickness, diagnose adenomyosis, endometrial polyps .Another important ability of 3D TVS is volume calculation using the Virtual Organ Computer-aided AnaLysis (VOCAL) even in irregularly shaped structures. This method has been demonstrated to be more accurate than 2D-volume estimation .
- Hysteroscopy has the advantage of directly visualizing the uterine cavity and the endometrium, allowing biopsy to be taken immediately from the suspected abnormality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women Age > 45 years postmenopausal uterine bleeding
Key inclusion criteria (2 listed)
- Women Age > 45 years
- with postmenopausal uterine bleeding
Key exclusion criteria (4 listed)
- Women with bleeding disorders or coagulopathy
- women with cervical cancer or breast carcinoma .
- history of tamoxifen intake
- women with fibroid .
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 |
|---|---|---|
| ultrasoundAlso: hysteroscopy, fractional currettageto evalute abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy | Diagnostic test | – |
Primary outcome
accuracy of 3d ultrasound in post menopausal bleeding
Time frame: 6months
to evalute women with postmenpausal uterine bleeding using three dimensional ultrasound assessment of endometrial volume
1 secondary outcome
comparison between hysteroscopy and ultrasound in post menopausal bleeding
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Background: PubMed 20567184Goldstein SR. Modern evaluation of the endometrium. Obstet Gynecol. 2010 Jul;116(1):168-176. doi: 10.1097/AOG.0b013e3181dfd557.
- Background: PubMed 21147030Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol. 2011 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10.
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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.
Ahmed Aref contact
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Bleeding, run by Cairo University.
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 2 inclusion and 4 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed Reda, M.D (+201000769315, mo.reda2011@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of 3d ultrasound in post menopausal bleeding (time frame: 6months). 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 NCT03847415, which also lists 2 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 20 Feb 2019.