Evaluation of the Uterine Cavity in Perimenopausal Women.

NCT06888414 | Active Not Recruiting DMC

• 1 other identifier: 1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Uterine Bleeding, Unspecified

Keywords

3D ultrasonography; Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (1)

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.

Diagnostic Test: transvaginal ultrasound

Interventions

transvaginal ultrasound 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.

Group 1

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Perimenopausal patients with presented to the outpatient clinic with abnormal uterine bleeding

You may qualify if:

• 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.

You may not qualify if:

• Age less than 40 and more than 55 years.
• Patients received hormonal treatment.
• Patients with chronic diseases or have coagulopathy.

Sponsors & Collaborators

• Suez University: lead

Study Sites (1)

faculty of medicine, Suez university

Suez, 43221, Egypt

Location

Related Publications (2)

• 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

  BACKGROUND

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

  RESULT

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: February 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)