Evaluation of the Uterine Cavity in Perimenopausal Women.

NCT ID: NCT06888414

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-05-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

transvaginal ultrasound

Intervention Type: DIAGNOSTIC_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.

Interventions

transvaginal ultrasound

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Suez University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Sewidan

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of medicine, Suez university

Suez, , Egypt

Countries

Egypt

References

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

Reference Type: BACKGROUND

Clinico histopathological evaluation of abnormal uterine bleeding in women of reproductive and perimenopausal age group

Reference Type: RESULT

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id