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

Conditions
Intraurineadhesions after endometrial ablation
Registration Number
NL-OMON23959
Lead Sponsor
none
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

•Women suffering symptoms from HMB, scheduled for a NovaSure endometrial ablation
•Women in pre-menopausal age

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 a history of a previous endometrial ablation or curettage
•Women with cervix pathology

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
We will investigate the prevalence and describe the severity of IUAs (using a valid scoring system, the American Fertility Society (AFS) classification system) following NovaSure treatment for HMB with NCH gel compared to a NovaSure treatment without the NCH gel. In order to prepare for a future hypothesis testing randomized trial.
Secondary Outcome Measures
NameTimeMethod
We will also investigate the complications (like uterus perforation and infection) that can occur during administration of the NCH gel in the uterus. Also, we will investigate dysmenorrhoea/ abdominal pain, PBAC score and menstrual bleeding pattern and patient’s satisfaction between the group of patients following NovaSure treatment with NCH and without the NCH gel.
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