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Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01376934
Enrollment
140
Registered
2011-06-20
Start date
2011-03-31
Completion date
Unknown
Last updated
2011-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy, Postmenopausal Women

Keywords

hysteroscopy, saline solution, carbon dioxide, compare two techniques in office hysteroscopy co2 and saline solution

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.

Interventions

PROCEDUREprocedure hysteroscopy

office hysteroscopy with gas or saline solution

Sponsors

University of Campinas, Brazil
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the comfort in office hysteroscopyone year140 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026