Abnormal Uterine Bleeding, UnspecifiedNCT06888414
Evaluation of the Uterine Cavity in Perimenopausal Women.
An observational study of Abnormal Uterine Bleeding, Unspecified, run by Suez University at 1 site in Egypt.
Trial summary
Abnormal uterine bleeding (AUB) in perimenopausal women is a common yet poorly defined condition requiring accurate diagnosis. Hysteroscopy is the gold standard for evaluating intrauterine abnormalities, but 3D ultrasonography (3D US) has emerged as a non-invasive alternative. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Unspecified
- What is being tested?
- transvaginal ultrasound
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Perimenopausal patients with presented to the outpatient clinic with abnormal uterine bleeding
Who may be able to join
- Age: 40 -55 years.
- Patients complaining of abnormal uterine bleeding not receiving hormonal treatment for the last three months or intrauterine device as it affects the endometrial thickness by ultrasound and the accuracy of the pathology.
- Free from chronic medical diseases: renal, liver, chest and heart diseases.
Who cannot join
- Age less than 40 and more than 55 years.
- Patients received hormonal treatment.
- Patients with chronic diseases or have coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Uterine Cavity by 3 D Ultrasonography in Perimenopausal Bleeding in Comparison With Hysteroscopy
Abnormal uterine bleeding (AUB) in perimenopausal women is a common yet poorly defined condition requiring accurate diagnosis. Hysteroscopy is the gold standard for evaluating intrauterine abnormalities, but 3D ultrasonography (3D US) has emerged as a non-invasive alternative.
Read the detailed description
Change in menstrual blood volume is a common manifestation of perimenopause, often indicative of underlying gynecological conditions. The etiology of perimenopausal bleeding is multifactorial and may include hormonal imbalances, endometrial polyps, malignancies, adenomyosis, vascular malformations, and systemic medical conditions.
The evaluation of uterine pathology can be achieved through both invasive and non-invasive diagnostic modalities. Ideally, non-invasive techniques are preferred due to their safety, cost-effectiveness, and ease of use. Ultrasonography is considered a reliable, non-invasive imaging tool for assessing uterine abnormalities and is often employed as a preliminary diagnostic step before invasive procedures such as hysteroscopy.
Among invasive techniques, hysteroscopy remains the gold standard for direct visualization of the uterine cavity. This method enables precise assessment of intrauterine pathology, facilitating accurate diagnosis and treatment planning. Compared to other imaging modalities, such as hysterosalpingography, hysteroscopy provides superior diagnostic accuracy and therapeutic potential.
Non-invasive diagnostic approaches, including transabdominal ultrasound (TAS) and two-dimensional transvaginal sonography (2D-TVS), are widely utilized in evaluating abnormal uterine bleeding (AUB). These modalities help detect uterine lesions such as fibroids, polyps, and focal abnormalities while also assessing adnexal pathology. Three-dimensional ultrasonography (3D-US) further enhances diagnostic capabilities by allowing multiplanar reconstruction from volumetric data, improving visualization of the endometrial cavity and providing a more detailed assessment of uterine morphology.
Three-dimensional transvaginal sonography (3D-TVS) is a cost-effective, non-invasive, and highly efficient method for indirectly visualizing the endometrial cavity. Given its accessibility and diagnostic accuracy, it is recommended as a first-line imaging modality for evaluating uterine lesions in reproductive-aged women presenting with abnormal uterine bleeding.
Despite advancements in diagnostic imaging, there remains a gap in knowledge regarding the optimal use of 3D transvaginal ultrasonography (3D-TVS) as a standalone tool for diagnosing intrauterine pathology. While hysteroscopy is the gold standard, further research is needed to refine the sensitivity and specificity of 3D-TVS in differentiating benign from malignant lesions, reducing the need for unnecessary invasive procedures.
- Conditions
- Abnormal Uterine Bleeding, Unspecified
- Being tested
- transvaginal ultrasound
- Keywords
- 3D ultrasonography, Hysteroscopy
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal ultrasoundDiagnostic test
Fifty perimenopausal women presenting with AUB were recruited from the outpatient clinic. Baseline data, including demographic, obstetric, and medical history, BMI, and laboratory investigations (CBC, renal and liver function tests, coagulation profile), were collected. All patients underwent transvaginal 3D ultrasonography and hysteroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Fifty perimenopausal women presenting with AUB were recruited from the outpatient clinic. Baseline data, including demographic, obstetric, and medical history, BMI, and laboratory investigations (CBC, renal and liver function tests, coagulation profile), were collected. All patients underwent transvaginal 3D ultrasonography and hysteroscopy. Receives: Diagnostic Test: transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of 3 D ultrasound in diagnosis of uterine causes perimenopausal bleeding versus hysteroscopy
Sensitivity and specificity of transvaginal ultrasound versus hysteroscopy in diagnosis perimenopausal bleeding.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Feb 2025
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (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 Abnormal Uterine Bleeding, UnspecifiedStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sewidan, Suez University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888414
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lalchandani S, Phillips K. Evaluation of endometrial cavity-investigation options. Reviews in Gynaecological Practice. 2003 Sep 1;3(3):165-70. https://doi.org/10.1016/S1471-7697(03)00065-0
Clinico histopathological evaluation of abnormal uterine bleeding in women of reproductive and perimenopausal age group
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Uterine Cavity by 3 D Ultrasonography in Perimenopausal Bleeding in Comparison With Hysteroscopy
- ClinicalTrials.gov ID
- NCT06888414
- Acronym / sponsor ID
- 1
- Conditions
- Abnormal Uterine Bleeding, Unspecified
- Keywords
- 3D ultrasonography, Hysteroscopy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Suez UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 21 Mar 2025 (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.
Abnormal uterine bleeding (AUB) in perimenopausal women is a common yet poorly defined condition requiring accurate diagnosis. Hysteroscopy is the gold standard for evaluating intrauterine abnormalities, but 3D ultrasonography (3D US) has emerged as a non-invasive alternative.
Detailed description
Change in menstrual blood volume is a common manifestation of perimenopause, often indicative of underlying gynecological conditions. The etiology of perimenopausal bleeding is multifactorial and may include hormonal imbalances, endometrial polyps, malignancies, adenomyosis, vascular malformations, and systemic medical conditions.
The evaluation of uterine pathology can be achieved through both invasive and non-invasive diagnostic modalities. Ideally, non-invasive techniques are preferred due to their safety, cost-effectiveness, and ease of use. Ultrasonography is considered a reliable, non-invasive imaging tool for assessing uterine abnormalities and is often employed as a preliminary diagnostic step before invasive procedures such as hysteroscopy.
Among invasive techniques, hysteroscopy remains the gold standard for direct visualization of the uterine cavity. This method enables precise assessment of intrauterine pathology, facilitating accurate diagnosis and treatment planning. Compared to other imaging modalities, such as hysterosalpingography, hysteroscopy provides superior diagnostic accuracy and therapeutic potential.
Non-invasive diagnostic approaches, including transabdominal ultrasound (TAS) and two-dimensional transvaginal sonography (2D-TVS), are widely utilized in evaluating abnormal uterine bleeding (AUB). These modalities help detect uterine lesions such as fibroids, polyps, and focal abnormalities while also assessing adnexal pathology. Three-dimensional ultrasonography (3D-US) further enhances diagnostic capabilities by allowing multiplanar reconstruction from volumetric data, improving visualization of the endometrial cavity and providing a more detailed assessment of uterine morphology.
Three-dimensional transvaginal sonography (3D-TVS) is a cost-effective, non-invasive, and highly efficient method for indirectly visualizing the endometrial cavity. Given its accessibility and diagnostic accuracy, it is recommended as a first-line imaging modality for evaluating uterine lesions in reproductive-aged women presenting with abnormal uterine bleeding.
Despite advancements in diagnostic imaging, there remains a gap in knowledge regarding the optimal use of 3D transvaginal ultrasonography (3D-TVS) as a standalone tool for diagnosing intrauterine pathology. While hysteroscopy is the gold standard, further research is needed to refine the sensitivity and specificity of 3D-TVS in differentiating benign from malignant lesions, reducing the need for unnecessary invasive procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: transvaginal ultrasoundFifty perimenopausal women presenting with AUB were recruited from the outpatient clinic. Baseline data, including demographic, obstetric, and medical history, BMI, and laboratory investigations (CBC, renal and liver function tests, coagulation profile), were collected. All patients underwent transvaginal 3D ultrasonography and hysteroscopy. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Perimenopausal patients with presented to the outpatient clinic with abnormal uterine bleeding
Key inclusion criteria (3 listed)
- Age: 40 -55 years.
- Patients complaining of abnormal uterine bleeding not receiving hormonal treatment for the last three months or intrauterine device as it affects the endometrial thickness by ultrasound and the accuracy of the pathology.
- Free from chronic medical diseases: renal, liver, chest and heart diseases.
Key exclusion criteria (3 listed)
- Age less than 40 and more than 55 years.
- Patients received hormonal treatment.
- Patients with chronic diseases or have coagulopathy.
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 ultrasoundFifty perimenopausal women presenting with AUB were recruited from the outpatient clinic. Baseline data, including demographic, obstetric, and medical history, BMI, and laboratory investigations (CBC, renal and liver function tests, coagulation profile), were collected. All patients underwent transvaginal 3D ultrasonography and hysteroscopy. | Diagnostic test | Group 1 |
Primary outcome
The efficacy of 3 D ultrasound in diagnosis of uterine causes perimenopausal bleeding versus hysteroscopy
Time frame: 3 months
Sensitivity and specificity of transvaginal ultrasound versus hysteroscopy in diagnosis perimenopausal bleeding.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- BackgroundLalchandani S, Phillips K. Evaluation of endometrial cavity-investigation options. Reviews in Gynaecological Practice. 2003 Sep 1;3(3):165-70. https://doi.org/10.1016/S1471-7697(03)00065-0
- Results publicationClinico histopathological evaluation of abnormal uterine bleeding in women of reproductive and perimenopausal age group
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Uterine Bleeding, Unspecified, run by Suez University at 1 site in Egypt.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
The efficacy of 3 D ultrasound in diagnosis of uterine causes perimenopausal bleeding versus hysteroscopy (time frame: 3 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 NCT06888414, 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 14 May 2025.