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NCT01376934 Clinical Trial

Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

Hysteroscopy Clinical Trial

Official title:
Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01376934
Other study ID # 01/2011/PC
Secondary ID
Status Recruiting
Phase N/A
First received June 16, 2011
Last updated June 17, 2011
Start date March 2011

Study information
Verified date June 2011
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Procedure:
• procedure hysteroscopy
office hysteroscopy with gas or saline solution

Locations
Country Name City State
Brazil Departamento de Tocoginecologia FCM UNICAMP Campinas São Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the comfort in office hysteroscopy 140 women will undergo office hysteroscopy to evaluate pain, time of the procedure and image quality using two techniques one with gas and the other with saline solution. one year No
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