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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
Information provided by:
University of Campinas, Brazil Identifier:
First received: June 16, 2011
Last updated: June 17, 2011
Last verified: June 2011
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.


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

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
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Please refer to this study by its identifier: NCT01376934

Departamento de Tocoginecologia FCM UNICAMP Recruiting
Campinas, São Paulo, Brazil, 13083881
Contact: Valter Fausto Santos, graduade medicine    5516 33717814 ext 203   
Contact: Ilza Maria Monteiro, Doctor degree    5516 97916241   
Sponsors and Collaborators
University of Campinas, Brazil
Principal Investigator: Valter Fausto Santos University of Campinas, Brazil
  More Information

Responsible Party: Departamento de Toco-Ginecologia do CAISM, UNICAMP Identifier: NCT01376934     History of Changes
Other Study ID Numbers: 01/2011/PC
Study First Received: June 16, 2011
Last Updated: June 17, 2011

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

Additional relevant MeSH terms:
Pharmaceutical Solutions processed this record on September 25, 2017