Role of MRI in Diagnosis of Postmenopausal Bleeding Causes

Assiut University (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

The aim of the study is to determine the diagnostic performance of MRI of endometrial pathology in postmenopausal women with postmenopausal bleeding

Condition or Disease Intervention/Treatment Phase
  • Device: MRI

Detailed Description

Postmenopausal bleeding is a common clinical problem accounting for approximately 5% of office visits to a general gynecologist.

Postmenopausal bleeding has been defined as:
  1. Vaginal bleeding occurring at least 6 months after complete cessation of menses in women not on hormonal replacement therapy (HRT).

  2. Noncyclic vaginal bleeding occurring in postmenopausal women who are receiving HRT Abnormal vaginal bleeding may be caused by a number of gynecologic or nongynecologic disorders. When evaluating a gynecologic etiology, the primary goal is to eliminate the possibility of endometrial cancer which is the cause of bleeding in approximately 10% of postmenopausal women presenting with this complaint and is the presenting symptom in 90% of women with endometrial cancer.

Other common gynecologic etiologies include endometrial polyps, endometrial hyperplasia, and submucosal fibroids along with the use of hormone replacement therapy, tamoxifen, and phytoestrogens Those pathologies should be discriminated to navigate the treatment process. Transvaginal ultrasonography (TVS) is the most efficient first-step technique for diagnosis of postmenopausal bleeding . The sensitivity of TVS to detect endometrial pathologies is high, but its specificity is low . Therefore, biopsy is recommended as a second-step diagnostic method when endometrial thickness exceeds 4 mm . However, endometrial biopsy or dilatation and curettage (D&C) may not be possible in postmenopausal patients due to endometrial atrophy, endometrial adhesions, or the requirement of general anesthesia. . Furthermore, besides pain and discomfort with endometrial sampling procedures, in some occasions such as vaginal/cervical stenosis or pelvic organ prolapse these procedures may be difficult to be done . Additionally, blind sampling may not be an effective approach for diagnosis of focal endometrial lesions and may be subject to sampling error .

MRI is an emerging modality for various reasons, such as exquisite soft-tissue resolution, its capability of multiplanar imaging, characterization, high sensitivity, and lack of ionizing radiation.

The sensitivity of MRI in identifying acute uterine pathologies is 96.6 % With recent advances in MR imaging techniques, diffusion weighted (DW) imaging and ADC value are useful in characterization of endometrial lesions because malignant lesions show high cellularity with little extracellular space which give restricted motion of water molecules and lower ADC values in contrast to benign lesions and normal tissues .

Study Design

Study Type:
Anticipated Enrollment :
36 participants
Observational Model:
Time Perspective:
Official Title:
Role of MRI in Diagnosis of Causes of Postmenopausal Bleeding in Correlation to Histopathological Results
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Outcome Measures

Primary Outcome Measures

  1. comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding [baseline]

    anaylsis between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding

Eligibility Criteria


Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  1. Any female patient after menopause suffering from vaginal bleeding.

  2. Patients receiving tamoxifen with vaginal bleeding.

  3. Patient had histopathological biopsy examination either by total hysterectomy, hysteroscopy or D &C.

  4. Patient must have local cause

Exclusion Criteria:
  1. Patients not amenable for MRI examination 2. Patients not in menopause 3. Patients have general bleeding tendency 4. Patients not underwent histopathological biopsy examination

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Assiut University


  • Principal Investigator: Hossam ElDen Mustafa Kamel, MD, unaffilitated

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Kholoud Khaled Salem Ali, Assistant lecturer, Assiut University Identifier:
Other Study ID Numbers:
  • MR imaging in uterus
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023