Randomised trial in women with heavy menstrual bleeding comparing Mirena IUD versus endomterial ablation.
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 266
Inclusion Criteria
We will study women suffering from menorrhagia. Menorrhagia will be defined as a report of cyclic heavy menstrual bleeding confirmed by a Pictorial Blood Assessment Chart (PBAC) exceeding 150 points. These women can either have had medical treatment without success for menorrhagia or decided that such treatment is no option for them.
Exclusion Criteria
1. Women with further child wish. Women with potential child wish will not be included since an endometrium ablation interferes with future pregnancies;
2. Women with an abnormal uterine cavity (myomas, polyps) determined by a TVU;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 20-05-2013: The primary outcome will be blood loss at 24 months after randomization, measured with the PBAC-score.
- Secondary Outcome Measures
Name Time Method Secondary measures of effectiveness will be the type and number of re-interventions after each treatment after 24 months, the rates of amenorrhea after the treatment at 6, 12 and 24 months and the pictorial chart scores at 6, 12 and 24 months and the quality of life scores as obtained from the SF 36 questionnaires.<br>20-05-2013: Measurement of VWF and Factor XI to investigate the prevalence of coagulation disorders and if lower levels of coagulation factors influence the effectiveness of the treatment. Separate informed consent will be asked for taking and analyzing blood from participating patients.