NCT05888545Unknown不适用
A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions
The Fourth Affiliated Hospital of Zhejiang University School of Medicine8 个研究点 分布在 1 个国家目标入组 1,176 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,176
- 试验地点
- 8
- 主要终点
- Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
研究概览
简要总结
The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.
详细描述
The main questions it aims to answer are
- The efficacy of the anti-adhesion diaphragm in preventing intrauterine adhesions;
- The duration of placement of the anti-adhesion septum in the uterus. Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. The control group will receive conventional treatment with no other interventions.
The researchers will compare the two groups to see if it is effective in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this trial and sign a written informed consent;
- •Women aged 18 ≤ age ≤ 40 years;
- •Those who had an abortion in early pregnancy, and those who had a cleanse.
排除标准
- •Patients with scars;
- •Patients with allergies;
- •Patients with acute genitourinary tract infections;
- •Patients with abnormalities of reproductive organs and abnormal uterine flexion after cesarean section;
- •Patients with decreased menstrual flow after previous curettage;
- •Patients with previous suspected or diagnosed uterine adhesions;
- •Patients on immunosuppressive drugs;
- •Patients with long-term use of antibiotics;
- •Patients with malignant tumors of the reproductive organs;
- •Patients with uterine adenomyosis, endometriosis, and uterine fibroids;
- •Patients with severe systemic diseases;
- •Patients with other conditions that are not suitable.
结局指标
主要结局
Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
时间窗: one week before the third menstrual cycle post-index procedure
The incidence of uterine adhesions was defined as the incidence of uterine adhesions in the control group of subjects with the uterine anti-adhesion septum placed to block the anterior and posterior uterine wall contact, and the incidence of adhesions in both groups was evaluated by ultrasound and/or hysteroscopy in the 3rd postoperative menstrual cycle.
次要结局
- Patient comfort after placement checklist(three months (third menstrual cycle) post-index procedure)
- Postoperative Menstrual time（days）(two week, three months (third menstrual cycle) post-index procedure)
- Patient acceptance chaecklist(three months (third menstrual cycle) post-index procedure)
- bleeding volume (Normal, decrease, increase)(two week, three months (third menstrual cycle) post-index procedure)
- Abdominal pain(two week, three months (third menstrual cycle) post-index procedure)
- Physician satisfaction checklist(three months (third menstrual cycle) post-index procedure)
研究者
研究点 (8)
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