- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06888414
Evaluation of the Uterine Cavity in Perimenopausal Women.
Evaluation of the Uterine Cavity by 3 D Ultrasonography in Perimenopausal Bleeding in Comparison With Hysteroscopy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Suez, Egypt, 43221
- faculty of medicine, Suez university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age less than 40 and more than 55 years.
- Patients received hormonal treatment.
- Patients with chronic diseases or have coagulopathy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The efficacy of 3 D ultrasound in diagnosis of uterine causes perimenopausal bleeding versus hysteroscopy
Time Frame: 3 months
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Sensitivity and specificity of transvaginal ultrasound versus hysteroscopy in diagnosis perimenopausal bleeding.
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3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 (Mobile Health and Wellness Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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