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Prevalence of intrauterine adhesions after NovaSure ablation with application of Hyaluronic acid.

Withdrawn
Conditions
intrauterine adhesions
10046828
Registration Number
NL-OMON48385
Lead Sponsor
Gynaecologie & Obstetrie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

Women suffering symptoms from heavy menstrual bleeding, scheduled for a
NovaSure endometrial ablation

Exclusion Criteria

* Women younger than 34
* Women with a desire to preserve fertility
* Women with intracavitary pathology or big intramural myoma seen by
transvaginal ultrasound.
* Women with cervix pathology

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>o the number of women with intrauterine adhesions, defined fibrous string at<br /><br>opposing wall of the uterus and/or cervix leading to partial or complete<br /><br>obliteration of the cavity<br /><br>o the severity of the intrauterine adhesions according to the AFS<br /><br>classification system</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>o Complications: uterus perforation and infection<br /><br>o Pain during and beyond menstruation according to the numeric rating scale<br /><br>(NRS)<br /><br>o Patient satisfaction according to the Likertscale<br /><br>o PBAC score and Menstruation bleeding pattern </p><br>
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