Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

Not Applicable

• Conditions: Postmenopausal Women; Hysteroscopy

• Registration Number: NCT01376934
• Lead Sponsor: University of Campinas, Brazil

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

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 Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Status Verified: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Last Update Submitted: 2011-06-17
• Study First Posted: 2011-06-20
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Departamento de Tocoginecologia FCM UNICAMP; 🇧🇷 Campinas, São Paulo, Brazil