NCT06478992尚未招募不适用
A Multicenter Randomized Controlled Trial of Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
First People's Hospital of Hangzhou0 个研究点目标入组 144 人开始时间: 2024年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- expulsion rate of the Mirena
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.
详细描述
This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (VAS) ≥40mm or menstrual volume score (PBAC) ≥100;
- •Adenomyosis was confirmed by ultrasound or magnetic resonance imaging (MRI);
- •The uterine volume measured by transvaginal gynecological three-dimensional ultrasound was more than 150cm3 and less than 280cm3 (the volume was about 280cm3 at 10 weeks of pregnancy); ④ A strong desire to preserve the uterus; ⑤ No fertility requirements within nearly one year;
- •Premenopausal women aged ≥18 years old; ⑦ Willing and able to abide by the study protocol, and have the ability to clearly judge the amount of menstruation and the degree of pain.
排除标准
- •Presence of contraindications to Mirena (known or suspected pregnancy, current pelvic inflammatory disease or recurrent pelvic inflammatory disease, lower genital tract infection, postpartum endometritis, infectious abortion within the past 3 months, cervicitis, cervical dysplasia, uterine or cervical malignant lesions, progestin-dependent tumors, abnormal uterine bleeding of unknown cause, congenital or acquired uterine abnormalities, these include fibroids that deform the cervix, conditions that increase susceptibility to infections, acute liver diseases or tumours, allergy to active ingredients or excipient);
- •Malignant tumors (including reproductive system and other systems);
- •Acute stage of heart, liver and kidney failure or other patients who cannot tolerate operation;
- •The history of Mirena displacement or expulsion;
- •Ultrasound showed the presence of ovarian chocolate cyst; ⑥ The presence of deep endometrial nodules by gynecological examination;
- •The presence of intramural or subserous myoma ≥3cm or any size of uterine submucosal myoma (type 0, 1, 2); ⑧ Patients who are unwilling to participate in the study or who were considered by the investigators to be unsuitable for the study.
结局指标
主要结局
expulsion rate of the Mirena
时间窗: 1, 3, 6, and 12 months postoperatively
次要结局
- dysmenorrhea(1, 3, 6, and 12 months postoperatively)
- uterine size under ultrasound(1, 3, 6, and 12 months postoperatively)
- menstrual volume(1, 3, 6, and 12 months postoperatively)
研究者
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