Incidence and predictors of re-intervention after Novasure endometrial ablation: a validation study in patients with abnormal uterine bleeding with data extraction from the Electronic Health Record and a Clinical Data Collector.
Completed
- Conditions
- Abnormal Uterine Bleeding
- Registration Number
- NL-OMON20077
- Lead Sponsor
- Máxima MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Woman who suffer from abnormal uterine bleeding and who previously underwent Novasure treatment in 2018 in Máxima MC
Exclusion Criteria
Previous surgical intervention for heavy menstrual bleeding
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surgical re-intervention in Máxima MC in women with abnormal uterine bleeding who underwent Novasure treatment in 2018
- Secondary Outcome Measures
Name Time Method - Patient characteristics: age, BMI, height and weight <br>- Time between Novasure and re-intervention <br>- Pre-existent Tubal ligation<br>- Pre-existent dysmenorrhea<br>- Uterine position<br>- Time and power ablation <br>- Analgesia (sedation, treatment room, Operating Room)