We plan to compare the costs and effects of both methods.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the mean blood loss at 24 months of follow-up, measured with
a PBAC-score.
Secondary outcome
Secondary outcomes are patient satisfaction, complications, number of
re-interventions, menstrual bleeding pattern,
including rates of amenorrhea, proportion of women with a PBAC-score <75,
quality of life, sexual function, presence of lower levels of coagulation
levels, sick leave and costs.
Background summary
A levonorgestrel releasing intrauterine system (LNG-IUS) and endometrial
ablation are two frequently used
methods for the treatment of menorrhagia, of which the first can be applied by
a general practitioner or a gynaecologist,
whereas the second is exclusively applied by a gynaecologist.
Study objective
We plan to compare the costs and effects of both methods.
Study design
Randomised controlled trial with a cost-effectiveness analysis and analysis of
coagulation factors alongside it.
Intervention
We will assess cost-effectiveness of two methods that are frequently used in
daily practice: a strategy
starting with a levonorgestrel releasing intrauterine system versus a strategy
starting with endometrial ablation for the
treatment of menorrhagia.
Study burden and risks
As we compare to current treatment strategies, participation in this trial will
not impose risk on the patients. Participants will be asked to fll out
questionnaire at five moments; it will take them about 15 minutes each time to
fill these out. Furthermore, we will take 12ml of blood at baseline from
patients who give informed consent.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Women suffering from menorrhagia, with a Pictorial Blood Assessment Chart (PBAC) exceeding 150 points
Exclusion criteria
*the desire to have (more) children
*Women with an abnormal uterine cavity (myomas, polyps) determined by a transVaginalUltrasound (TVU)
* Women with large intramural myoma determined by a TVU
* Women younger than 34 years
* Sound length more than 10 cm measured at TVU
* Uterine size exceeding 10 weeks of gestation by bimanual manipulation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38243.018.11 |