Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women

Not Applicable

Completed

• Conditions: Uterine Bleeding

• Registration Number: NCT02705222
• Lead Sponsor: Mohamed Sayed Abdelhafez

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.

Study Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of abnormal endometrial patterns	One week after the procedure	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

Name	Time	Method
Improvement rate	3 months after the procedure	Number of patients improved after performing the procedure and recieving the treatment-specific to cause per total number of patients underwent the procedure

Trial Locations

Locations (1)

Obstetrics and Gynecology Department in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt