Prevalence of intrauterine adhesions after NovaSure ablation with application of Hyaluronic acid.
Withdrawn
- Conditions
- intrauterine adhesions10046828
- 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- Withdrawn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
Name Time Method <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
Name Time Method <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>