Clinical trial NCT02705222: 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
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Bleeding
Keywords: Abnormal uterine bleeding
Dilatation and curettage
Hysteroscopy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Percentage of abnormal endometrial patterns
timeFrame: One week after the procedure
Secondary outcomes:
measure: Improvement rate
timeFrame: 3 months after the procedure
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sara M Madany
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Moustafa H Nawwar, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed A Elnegeri, Prof
role: STUDY_CHAIR
References: