An interventional study of Intrauterine device and Uterine artery embolization in Adenomyosis, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to female participants aged 19 Years to 48 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.
Screening
Intervention
Follow-up visit #1 (1 month)
Follow-up visit #2 (3 month)
Follow-up visit #3 (6 months)
Follow-up visit #4 (12months)
138 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.
This study's planned enrollment of 56 is below the median of 100 across 75 interventional studies indexed under Adenomyosis.
Browse Adenomyosis studies →Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
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1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin \< 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea)
Exclusion Criteria:
1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet \< 50,000 or INR > 1.5) 4. Concomitant endometriosis 5. Pregnancy
Procedure: Intrauterine device
Procedure: Uterine artery embolization
The vagina is visually inspected to check the size and position of the uterus. The speculum is inserted into the vagina. The IUD is placed inside the uterus and then the strings are cut.
The right common femoral artery is punctured under ultrasound guidance and a 5F vascular sheath is inserted into the Rt common femoral artery. A 5F catheter was inserted into the internal iliac artery, and a 2.0F microcatheter is advanced into the uterine artery. Embolization is performed using polyvinyl alcohol (PVA). One third (20 mL) of a 60-mL mixture comprising 150-250-µm PVA particles was injected at the beginning of embolization into each uterine artery, followed by injection of at least two thirds (40 mL) to all (60 mL) of a mixture comprising 250-355- µm PVA particles and finally completion with 355-500- µm PVA particles. Embolization was performed until complete cessation of blood flow in the ascending uterine artery for 10 heart beats.
Hemoglobin level
Hemoglobin as an indicator of menstrual bleeding
Time frame: Hemoglobin level at 6 and 12 months after each procedure
Pictorial blood loss assessment chart (PBAC)
Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (\>100 considered as heavy mentrual blood)
Time frame: 0,6,12 months
Visual analogue scale
Visual analogue scale: a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Time frame: 0,6,12 months
Symptom and quality of life score questionnaire
Symptom and quality of life score questionnaire: a questionnaire developed to objectively assess symptom severity and quality of life in relation to uterine adenomyosis before and after procedure
Time frame: 0,6,12 months
Uterine volume
Time frame: 0,12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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