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

Comparison Between Dilatation and Curettage and Hysteroscopy in Management of Abnormal Uterine Bleeding in Perimenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Uterine Bleeding
• Intervention / Treatment: Procedure: D&C; Procedure: Hysteroscopy

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35111
      • Obstetrics and Gynecology Department in Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: D&C group; Women will undergo D&C	Procedure: D&C; Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination; Other Names: Dilatation and curettage
ACTIVE_COMPARATOR: Hysteroscopy group; Women will undergo hysteroscopy	Procedure: Hysteroscopy; Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One week after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months after the procedure

Collaborators and Investigators

• Sponsor: Mohamed Sayed Abdelhafez
• Investigators: Principal Investigator: Sara M Madany, Mansoura University; Study Director: Moustafa H Nawwar, Dr, Mansoura University; Study Chair: Mohamed A Elnegeri, Prof, Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (ESTIMATE): March 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Hysteroscopy; Abnormal uterine bleeding; Dilatation and curettage
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: SMM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED