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Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by University of Campinas, Brazil.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376934
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campinas, Brazil
  Purpose
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

Condition Intervention
Postmenopausal Women Hysteroscopy Procedure: procedure hysteroscopy

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Evaluation of the comfort in office hysteroscopy [ Time Frame: one year ]
    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.


Estimated Enrollment: 140
Study Start Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: procedure hysteroscopy
    office hysteroscopy with gas or saline solution
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376934


Locations
Brazil
Departamento de Tocoginecologia FCM UNICAMP Recruiting
Campinas, São Paulo, Brazil, 13083881
Contact: Valter Fausto Santos, graduade medicine    5516 33717814 ext 203    valter.fausto@yahoo.com.br   
Contact: Ilza Maria Monteiro, Doctor degree    5516 97916241    ilza@unicamp.br   
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Valter Fausto Santos University of Campinas, Brazil
  More Information

Responsible Party: Departamento de Toco-Ginecologia do CAISM, UNICAMP
ClinicalTrials.gov Identifier: NCT01376934     History of Changes
Other Study ID Numbers: 01/2011/PC
First Submitted: June 16, 2011
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by University of Campinas, Brazil:
hysteroscopy
saline solution
carbon dioxide
compare two techniques in office hysteroscopy co2 and saline solution

Additional relevant MeSH terms:
Pharmaceutical Solutions