Hysteroscopy Clinical Trial
Official title:
Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution
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 |
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
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 |
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Brazil | Departamento de Tocoginecologia FCM UNICAMP | Campinas | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
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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