Uterine Cavity Assessment and Endometrial Hormonal Receptors in Women With Peri and Post Menopausal Bleeding
Primary Purpose
Vaginal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hystroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginal Bleeding focused on measuring perimenopausal bleeding, postmenopausal bleeding, hysteroscopy, Steroid receptors
Eligibility Criteria
Inclusion Criteria:
- women older than 45 years with Abnormal uterine bleeding for more than 3 months duration
Exclusion Criteria:
- history of hormonal treatment or hormonal contraception within the last 6 months. Women who had used IUD or those had hysteroscopy or fractional curettage done within the last 6 months
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
women with anbormal bleeding
Arm Description
women with perimenopausal and postmenopausal bleeding who will be evaluated with transvaginal ultrasound, saline sonohysterography,hystroscopy and endometrial currettage
Outcomes
Primary Outcome Measures
detection of endometrial lesion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02385747
Brief Title
Uterine Cavity Assessment and Endometrial Hormonal Receptors in Women With Peri and Post Menopausal Bleeding
Official Title
Assessment of Uterine Cavity and Endometrial Steroid Receptors in Women With Peri- and Post Menopausal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional curettage followed by histopathological examination and immunohistochemical analysis for estrogen and progesterone receptors.
Detailed Description
Conventional TVUS will be done to all participants to measure the uterine size & endometrial thickness and other pathology. TVUS will be done with an empty bladder in the lithotomy position using an endovaginal curved linear probe (EV 4-9/10 ED) with frequency 4-9 MHz.
SIS will be performed for all patients at the same setting of TVUS. With the patient in the lithotomy position, . A 6 or 8 French Foley's catheter will be inserted through the external cervical os into the cervical canal. Its balloon tip will be inflated with 2-3 mL of saline, depending on patient comfort, to help hold it in place. The speculum was then removed.
The vaginal probe was then reinserted and a 5-10 mL syringe filled with sterile saline was attached to the catheter. Fluid will be instilled while the transducer moved from side to side (cornua to cornua) in a long-axis projection then the transducer was rotated 90° into an axial plane. More fluid was instilled while fanning down toward the endocervical canal and up toward the uterine fundus to obtain a detailed survey of the endometrium. Every portion of the uterine cavity should be imaged, to exclude any focal abnormality as polyps, myomas, hyperplasia, and carcinoma. Any detected intrauterine pathology is described; including its shape, size and site.
The hysteroscope used in this study is a rigid continuous flow panoramic hysteroscope, 25 cm in length, 4 mm in diameter with an outer sheath 5 mm diameter and 30° fibro-optic lens.
The technique used to provide constant uterine distention will be by attaching plastic bags of saline. Infusion pressure was elevated by pneumatic cuff under manometric control at a pressure of 100-120 mmHg.
Detailed hysteroscopic examination will be performed under general anesthesia with the patient in the lithotomy position, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity will be observed and recorded.
Endometrial curettage will be done to all patients, and specimens were fixed in Formalin 10% solution for histopathological examination. Patients in whom endometrial polyps were found by hysteroscopy, had polypectomy performed before curettage. The first sample will be taken from the endocervical canal before hysteroscopy or cervical dilatation. Following diagnostic hysteroscopy, cervical dilatation u. A sharp curette will be introduced into the uterine cavity, and curettage will be done starting with the fundus then posterior, anterior, right and left lateral walls consecutively.
Histopathological examination. All curettage & polypectomy specimens were embedded in paraffin wax, then slides will be prepared to be stained by the conventional Haematoxylin and Eosin (H & E) stain.
Detection of estrogen & progesterone receptors in the specimens (formalin-fixed, paraffin wax-embedded) using immunohistochemical staining which will be carried out by using the Dako ER/PR pharmDx™ Kit which specifically detects the ERα protein as well as the PR-A protein located in the cell nuclei of ER and PR expressing cells, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Bleeding
Keywords
perimenopausal bleeding, postmenopausal bleeding, hysteroscopy, Steroid receptors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
women with anbormal bleeding
Arm Type
Experimental
Arm Description
women with perimenopausal and postmenopausal bleeding who will be evaluated with transvaginal ultrasound, saline sonohysterography,hystroscopy and endometrial currettage
Intervention Type
Procedure
Intervention Name(s)
hystroscopy
Intervention Description
Detailed hysteroscopic examination under general anesthesia Once the cavity entered, a panoramic view of the uterine cavity then systematic; first the fundus, then anterior, posterior and lateral walls of the uterus consecutively, ending by visualization of the uterine -tubal junctions, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity was observed and recorded. If there is any intrauterine pathology detected; the shape, size and site were estimated.
Primary Outcome Measure Information:
Title
detection of endometrial lesion
Time Frame
2 days after curretage
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women older than 45 years with Abnormal uterine bleeding for more than 3 months duration
Exclusion Criteria:
history of hormonal treatment or hormonal contraception within the last 6 months. Women who had used IUD or those had hysteroscopy or fractional curettage done within the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
12. IPD Sharing Statement
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Uterine Cavity Assessment and Endometrial Hormonal Receptors in Women With Peri and Post Menopausal Bleeding
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