Symptomatic uterine fibroids
Conditions
Interventions
control gruop:Uterine artery embolization with Embosphere microspheres
Experimental group:Uterine artery embolization with polyethylene glycol embolization microspheres
Sponsors
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 60 years old (including threshold),pre-menopausal women; 2. Uterine fibroids were diagnosed by enhanced MRI; 3. Accompanied by at least one of the following symptoms caused by uterine fibroids: abnormal menstruation (such as increased menstrual volume, prolonged menstrual period, dripping);Symptoms related to mass/compression caused by fibroids, such as pelvic compression, abdominal enlargement, abdominal distention, gastroenteric compression (back pain, constipation), bladder compression (frequent urination, urinary retention), vaginal compression, etc.; 4. First uterine artery embolization treatment; 5. Understand the purpose of the experiment, sign the informed consent voluntarily, and follow the protocol.
Exclusion criteria
Exclusion criteria: 1.Renal insufficiency, such as serum creatinine greater than 2 times the upper limit of normal; 2. Coagulation dysfunction, such as activated partial thromboplastin time (APTT), prothrombin Time (PT) greater than 2 times the upper limit of normal; 3. Contraindications of interventional embolization, such as hypersensitivity to contrast agent, skin infection at the puncture site, and severe Immunosuppression; 4. Combined with adenomyosis; 5.Combined genitourinary system infection; 6.Suspected gynecological malignancy; 7.Pedicled serous fibroids, broad ligament fibroids or uterine neck fibroids were the main fibroids; 8.The diameter of submucosal uterine fibroids was > 5cm; The diameter of interparietal myoma was > 10cm; 9.Those who have fertility requirements in the next year; 10.Patients who underwent ablation, focused ultrasound, or myomectomy for uterine fibroids within 1 year before surgery; 11.Patients who received drug treatment for uterine fibroids 1 month before surgery; 12. Pregnant or lactating women; 13.Participating in other clinical trials and have not yet been discharged; 14.The researchers considered that it was not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of fibroid infarcts; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of embolization;Uterine fibroid volume;Menstrual conditions;HGB;uterine fibroid symptom and health-related quality of life,UFS-QOL; | — |
Countries
China
Contacts
Public ContactWang Jiandong
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Outcome results
None listed