Multicentre study comparing two endometrial ablation techniques in the office: bipolar endometrial ablation versus balloon endometrial ablatio

Completed

• Conditions: Endometrial ablation in women with menorrhagia; Urological and Genital Diseases; Excessive bleeding in the premenopausal period

• Registration Number: ISRCTN17974690
• Lead Sponsor: Maxima Medical Center (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

1. Women (aged 34 to 55 years) with menorrhagia ( > 150 points on Higham pictorial chart score)
2. Normal uterine cavity (confirmed by saline infusion sonography or hysteroscopy)
3. Normal Pap smear
4. A premenopausal follicular stimulating hormone (FSH)-level of less than 40 IU/I

Exclusion Criteria

1. Presence of coagulopathies
2. Use of anti-coagulants
3. A desire to preserve fertility
4. Prior uterine surgery, other than low segment Caesarean section
5. Suspected or confirmed uterine malignancy
6. Intra cavitairy pathology, except polyps < 1cm

Study & Design

• Study Type: Interventional
• Study Design: Not specified