Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women
Primary Purpose
Uterine Bleeding
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
D&C
Hysteroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Uterine Bleeding focused on measuring Abnormal uterine bleeding, Dilatation and curettage, Hysteroscopy
Eligibility Criteria
Inclusion Criteria:
- Perimenopausal women complaining of abnormal uterine bleeding (menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia) without local gynecological cause.
- Failure of medical treatment for at least 3 months.
Exclusion Criteria:
- Age < 45 or > 55 years.
- Blood disorders or coagulopathy.
- Diagnosed or suspected local gynecologic lesion (polyp, adenomyosis, myoma, malignancy or cervical pathology).
- Use intrauterine contraceptive device.
- Pregnancy related conditions.
Sites / Locations
- Obstetrics and Gynecology Department in Mansoura University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
D&C group
Hysteroscopy group
Arm Description
Women will undergo D&C
Women will undergo hysteroscopy
Outcomes
Primary Outcome Measures
Percentage of abnormal endometrial patterns
Number of patients diagnosed to have abnormal endometrial patterns after histopathological examination of the curretings per total number of patients underwent the procedure
Secondary Outcome Measures
Improvement rate
Number of patients improved after performing the procedure and recieving the treatment-specific to cause per total number of patients underwent the procedure
Full Information
NCT ID
NCT02705222
First Posted
February 26, 2016
Last Updated
October 25, 2018
Sponsor
Mohamed Sayed Abdelhafez
1. Study Identification
Unique Protocol Identification Number
NCT02705222
Brief Title
Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women
Official Title
Comparison Between Dilatation and Curettage and Hysteroscopy in Management of Abnormal Uterine Bleeding in Perimenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Sayed Abdelhafez
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of treatment-specific to the cause.
Detailed Description
Perimenopausal women complaining of abnormal uterine bleeding will be selected for assessment through detailed history taking, general and abdominal examination, local gynecological examination, transvaginal sonography (TVS) scanning and routine blood investigations. Eligible participants in our study will be those who complain of menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia without local gynecological cause with failure of medical treatment for at least 3 months. All women participating in the study will be randomly allocated into two groups; dilatation and curettage (D&C) group and hysteroscopy group. For women in the D&C group, cervical dilatation and fractional endometrial curettage will be done under total intravenous (IV) anesthesia in operation theater and the curetting will be sent for histopathological examination. For women in the hysteroscopy group, hysteroscopy will be done under total IV anesthesia in operation theater hysteroscopic-guided curettings will also be taken and sent for histopathological examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Bleeding
Keywords
Abnormal uterine bleeding, Dilatation and curettage, Hysteroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D&C group
Arm Type
Active Comparator
Arm Description
Women will undergo D&C
Arm Title
Hysteroscopy group
Arm Type
Active Comparator
Arm Description
Women will undergo hysteroscopy
Intervention Type
Procedure
Intervention Name(s)
D&C
Other Intervention Name(s)
Dilatation and curettage
Intervention Description
Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Intervention Description
Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination
Primary Outcome Measure Information:
Title
Percentage of abnormal endometrial patterns
Description
Number of patients diagnosed to have abnormal endometrial patterns after histopathological examination of the curretings per total number of patients underwent the procedure
Time Frame
One week after the procedure
Secondary Outcome Measure Information:
Title
Improvement rate
Description
Number of patients improved after performing the procedure and recieving the treatment-specific to cause per total number of patients underwent the procedure
Time Frame
3 months after the procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Perimenopausal women complaining of abnormal uterine bleeding (menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia) without local gynecological cause.
Failure of medical treatment for at least 3 months.
Exclusion Criteria:
Age < 45 or > 55 years.
Blood disorders or coagulopathy.
Diagnosed or suspected local gynecologic lesion (polyp, adenomyosis, myoma, malignancy or cervical pathology).
Use intrauterine contraceptive device.
Pregnancy related conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara M Madany
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Moustafa H Nawwar, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed A Elnegeri, Prof
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Obstetrics and Gynecology Department in Mansoura University Hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women
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