A Study to Compare the Effectiveness of Two Different Outpatient Endometrial Ablation Techniques Used for Heavy Periods
Launched by BIRMINGHAM WOMEN'S NHS FOUNDATION TRUST · May 14, 2010
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
Heavy menstrual bleeding (HMB) or 'menorrhagia' is a common condition with a major impact on health-related quality of life and health resource utilization in both primary and secondary care. In over 50% of cases no organic pathology is present and the term dysfunctional uterine bleeding (DUB) is used. First line treatment of DUB is medical and where this fails, surgery is indicated using either minimally invasive approaches (endometrial ablation) or major surgery (hysterectomy). Endometrial ablation has been extensively evaluated against the gold standard of hysterectomy and shown to be ef...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
- • Premenopausal follicular follicle stimulating hormone (FSH) level of less than 40 IU/L.
- • Associated functional disability (negative impact on life quality).
- • Lack of response to medical treatment.
- • Prepared to undergo surgical treatment without general anaesthesia
- Exclusion Criteria:
- • Women under 25 years
- • Suspected genital tract infection
- • Uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids \> 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
- • Uterine cavity length \>11cm
- • Adnexal pathology
- • Previous open myomectomy or endometrial ablation / resection and classical caesarian section
- • patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)
About Birmingham Women's Nhs Foundation Trust
Birmingham Women's NHS Foundation Trust is a leading healthcare organization dedicated to providing high-quality women's and neonatal services. Committed to advancing clinical research, the Trust plays a pivotal role in conducting innovative clinical trials that aim to improve health outcomes for women and their families. With a multidisciplinary approach, the Trust collaborates with various stakeholders to ensure rigorous scientific standards and ethical practices are upheld in all research initiatives. Its focus on patient-centered care and commitment to excellence positions Birmingham Women's NHS Foundation Trust as a key contributor to advancements in women's health and medical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Justin Mr Clark, MD MRCOG
Principal Investigator
Birmingham Women's NHS Foundation Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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