Randomised trial in women with heavy menstrual bleeding comparing Mirena IUD versus endomterial ablation.

RCT comparing the levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation in women suffering from menorrhagia (MIRA).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19998

Enrollment

266

Registered

2011-07-12

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia is defined as cyclic heavy menstrual bleeding (>80 ml) over several consecutive cycles. Menorrhagia is inconvenient, and it induces menstrual pain, anaemia, tiredness and sexual dysfunction, thus affecting quality of life. It is also associated with an increased medical consultation and menstruation-related sick leave. Various drug and hormonal therapies are applied and a substantial part of women suffering from menorrhagia receives a hysterectomy in the end, with an associated risk

Interventions

After randomisation, women allocated to LNG-IUS will get a device inserted by a general practitioner or a gynaecologist, whereas women allocated to endometrial ablation will be scheduled for endometri

Eligibility

Inclusion criteria

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

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; 3. Women with large intramural myoma determined by a TVU; 4. Women younger then 34 years; 5. Abnormal cervical cytology; 6. Sound length more then 10 cm measured at TVU; 7. Uterine size exceeding 10 weeks of gestation by bimanual manipulation.

Design outcomes

Primary

Measure	Time frame
20-05-2013: The primary outcome will be blood loss at 24 months after randomization, measured with the PBAC-score.	—

Secondary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

—

Contacts

Public ContactMarlies Bongers

Máxima Medisch Centrum, Locatie Veldhoven, P.O. Box 7777

m.bongers@mmc.nl+31 (0)40 8888000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)