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

NCT02705222 | Completed

• 1 other identifier: SMM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Bleeding

Keywords

Abnormal uterine bleeding; Dilatation and curettage; Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement rate

  3 months after the procedure

Study Arms (2)

D&C group

ACTIVE COMPARATOR

Women will undergo D\&C

Procedure: D&C

Hysteroscopy group

ACTIVE COMPARATOR

Women will undergo hysteroscopy

Procedure: Hysteroscopy

Interventions

D&C PROCEDURE

Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination

Also known as: Dilatation and curettage

D&C group

Hysteroscopy PROCEDURE

Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination

Hysteroscopy group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Sayed Abdelhafez: lead

Study Sites (1)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Metrorrhagia; Dilatation, Pathologic

Interventions

Dilatation and Curettage; Hysteroscopy

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Obstetric Surgical Procedures

Study Officials

• Sara M Madany

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed S Abdelhafez, Dr

  Mansoura University

  STUDY DIRECTOR

• Moustafa H Nawwar, Dr

  Mansoura University

  STUDY DIRECTOR

• Mohamed A Elnegeri, Prof

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

EG (1)