Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

• Sponsor: University of Campinas, Brazil (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01376934
• Collaborator: (none)
• Enrollment: 140
• Location: 1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Women; Hysteroscopy	Procedure: procedure hysteroscopy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• 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
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Mar 1, 2011

Outcome Measures

Primary Outcome Measures

1. Evaluation of the comfort in office hysteroscopy [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Departamento de Tocoginecologia FCM UNICAMP	Campinas	São Paulo	Brazil	13083881

Sponsors and Collaborators

• University of Campinas, Brazil

Investigators

• Principal Investigator: Valter Fausto Santos, University of Campinas, Brazil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01376934
• Other Study ID Numbers: 01/2011/PC
• First Posted: Jun 20, 2011
• Last Update Posted: Jun 20, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: hysteroscopy; saline solution; carbon dioxide; compare two techniques in office hysteroscopy co2 and saline solution

Study Results

No Results Posted as of Jun 20, 2011