Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

NCT ID: NCT01376934

Last Updated: 2011-06-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality

Detailed Description

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The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.

There will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.

Conditions

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Postmenopausal Women Hysteroscopy

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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procedure hysteroscopy

office hysteroscopy with gas or saline solution

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women post-menopausal with abnormal uterine bleeding, ultrasound with thick endometrial distorted

Exclusion Criteria

* Women with uterine malformations
* Women with mental retardation
* Women underwent pelvic radiotherapy
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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UNICAMP

Principal Investigators

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Valter Fausto Santos

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

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Departamento de Tocoginecologia FCM UNICAMP

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Valter Fausto Santos, graduade medicine

Role: primary

5516 33717814 ext. 203

Ilza Maria Monteiro, Doctor degree

Role: backup

5516 97916241

Other Identifiers

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01/2011/PC

Identifier Type: -

Identifier Source: org_study_id

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