Postmenopausal BleedingNCT02488798
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding
An observational study of Postmenopausal Bleeding, run by Cairo University.
Trial summary
100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis. Read more about this study
- Who is it for?
- Ages 47 to 64 years, women only
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- 2D grey scale vaginal ultrasound, 3D power Doppler vaginal ultrasound and Office hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2014
- 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 47 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with postmenopausal bleeding
Who may be able to join
- 100 patients complaining of postmenopausal bleeding. Postmenopausal bleeding was defined as vaginal bleeding that occurred after at least 12 months of amenorrhea.
Who cannot join
- Exclusion criteria included any history of hormone administration in the last 6 months, any medical condition that might cause abnormal uterine bleeding like coagulation disorders, hypertension, cardiac disease, thyroid disorders or hepatic condition.
About this study
Official title: The Role of Office Hysteroscopy and Endometrial Power Doppler Using the International Endometrial Tumor Analysis Group Classification in the Evaluation of Postmenopausal Bleeding
100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis.
Read the detailed description
The aim was to compare the efficiency of the upper mentioned interventions in diagnosing the cause of postmenopausal bleeding.
- Conditions
- Postmenopausal Bleeding
- Being tested
- 2D grey scale vaginal ultrasound, 3D power Doppler vaginal ultrasound, Office hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D grey scale vaginal ultrasoundProcedure or surgery
To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).
3D power Doppler vaginal ultrasoundProcedure or surgery
To assess the endometrium using the IETA group criteria.
Office hysteroscopyProcedure or surgery
using the vaginoscopic approach to assess the uterine cavity and take sample.
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal bleeding group | 100 women with postmenopausal bleeding undergoing 2D greyscale vaginal ultrasound and 3D Endometrial power Doppler and the features were classified using six different vascular patterns described by IETA group including the following patterns; single dominant vessel without branching, with branching, multiple vessels with focal origin, with multifocal origin at the myometrium-endometrium junction, scattered vessels or circular flow (Kucur et al., 2013 ).
All patients then had Office hysteroscopy carried out in the outpatient clinic using vaginoscopic approach (Cooper et al., 2010). With endometrial samples from lesions or from the cavity for histopathological analysis. Receives: Procedure: 2D grey scale vaginal ultrasound; Procedure: 3D power Doppler vaginal ultrasound; Procedure: Office hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding
Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Ahmed Bassiouny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488798
- Sponsor's protocol ID
- 62014
- Status last verified
- Jun 2015
- First submitted
- 30 Jun 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Office Hysteroscopy and Endometrial Power Doppler Using the International Endometrial Tumor Analysis Group Classification in the Evaluation of Postmenopausal Bleeding
- ClinicalTrials.gov ID
- NCT02488798
- Acronym / sponsor ID
- 62014
- Conditions
- Postmenopausal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jul 2015 (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.
100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis.
Detailed description
The aim was to compare the efficiency of the upper mentioned interventions in diagnosing the cause of postmenopausal bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postmenopausal bleeding group | – | Procedure: 2D grey scale vaginal ultrasound, Procedure: 3D power Doppler vaginal ultrasound, Procedure: Office hysteroscopy100 women with postmenopausal bleeding undergoing 2D greyscale vaginal ultrasound and 3D Endometrial power Doppler and the features were classified using six different vascular patterns described by IETA group including the following patterns; single dominant vessel without branching, with branching, multiple vessels with focal origin, with multifocal origin at the myometrium-endometrium junction, scattered vessels or circular flow (Kucur et al., 2013 ). All patients then had Office hysteroscopy carried out in the outpatient clinic using vaginoscopic approach (Cooper et al., 2010). With endometrial samples from lesions or from the cavity for histopathological analysis. |
Who may qualify
- Ages
- 47 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with postmenopausal bleeding
Key inclusion criteria (1 listed)
- 100 patients complaining of postmenopausal bleeding. Postmenopausal bleeding was defined as vaginal bleeding that occurred after at least 12 months of amenorrhea.
Key exclusion criteria (1 listed)
- Exclusion criteria included any history of hormone administration in the last 6 months, any medical condition that might cause abnormal uterine bleeding like coagulation disorders, hypertension, cardiac disease, thyroid disorders or hepatic condition.
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 |
|---|---|---|
| 2D grey scale vaginal ultrasoundTo assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform). | Procedure or surgery | postmenopausal bleeding group |
| 3D power Doppler vaginal ultrasoundTo assess the endometrium using the IETA group criteria. | Procedure or surgery | postmenopausal bleeding group |
| Office hysteroscopyusing the vaginoscopic approach to assess the uterine cavity and take sample. | Procedure or surgery | postmenopausal bleeding group |
Primary outcome
Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding
Time frame: 1 week
Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.