Text Size

Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

This study is currently recruiting participants.
Verified June 2011 by University of Campinas, Brazil
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01376934
First received: June 16, 2011
Last updated: June 17, 2011
Last verified: June 2011
History of Changes
  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: Open Label
Primary Purpose: Health Services Research
Official Title: Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Evaluation of the comfort in office hysteroscopy [ Time Frame: one year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Departamento de Toco-Ginecologia do CAISM, UNICAMP
ClinicalTrials.gov Identifier: NCT01376934     History of Changes
Other Study ID Numbers: 01/2011/PC
Study First Received: June 16, 2011
Last Updated: June 17, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 21, 2013