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

NCT ID: NCT02705222

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Uterine Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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D&C group

Women will undergo D\&C

Group Type ACTIVE_COMPARATOR

D&C

Intervention Type PROCEDURE

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

Hysteroscopy group

Women will undergo hysteroscopy

Group Type ACTIVE_COMPARATOR

Hysteroscopy

Intervention Type PROCEDURE

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

Interventions

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D&C

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

Intervention Type PROCEDURE

Hysteroscopy

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

Intervention Type PROCEDURE

Other Intervention Names

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Dilatation and curettage

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Sayed Abdelhafez

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sayed Abdelhafez

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sara M Madany

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Mohamed S Abdelhafez, Dr

Role: STUDY_DIRECTOR

Mansoura University

Moustafa H Nawwar, Dr

Role: STUDY_DIRECTOR

Mansoura University

Mohamed A Elnegeri, Prof

Role: STUDY_CHAIR

Mansoura University

Locations

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Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SMM

Identifier Type: -

Identifier Source: org_study_id

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