Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
Comparison of the Therapeutic Effects of Vaginal Repair and Vaginal Repair + Metformin in the Treatment of Cesarean Section Scar Defect
Cesarean section scar defect (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women.
No clinical guidelines have been issued for the management of CSD.
The investigators have previously demonstrated that vaginal repair of CSD was an relative effective treatment of CSD.
However, only 28.2% of the CSD patients normalized to less than 7 days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months post vaginal repair.
The previous research suggested that the occurrence of CSD may be related to the aging phenotype of the myometrium.
Metformin, as a classic diabetes treatment drug, has an important position in anti-aging therapy.
Therefore, the randomized study was designed to evaluate whether the application of metformin in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
研究概览
详细说明
The previous research suggested that the occurrence of cesarean section scar defect (CSD) may be related to the aging phenotype of the myometrium. The aging of the myometrium in some cesarean section patients reduces the proliferation and repair of smooth muscle cells and endometrial cells to a certain extent. The prognosis of vaginal repair is poor and the repair of the endometrium during menstruation is not good.
Metformin, as a classic diabetes treatment drug, has an important position in anti-aging therapy. Its research and application range is the widest, and significant results have been achieved in a number of clinical trials. At the same time, its side effects are less than other anti-aging drugs, and the patient adaptability is better. It maybe the best choice for the treatment of anti-aging diseases. Therefore, the randomized study was designed to evaluate whether the application of metformin in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200092
- Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Patients are younger than 40 and over the age of 18.
- Clearly diagnosed with CSD.
- Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days).
- The thickness of the remaining muscular layer of CSD was less than 3 mm.
- Normal range of blood sugar and insulin
- No serious medical problems (important viscera function in the normal range).
- No uterine fibroids, endometriosis, adenomyosis
- No malignant tumors.
- Sign the informed consent.
Exclusion Criteria:
- Over the age of 40 or younger than 18;
- Indefinite diagnosis.
- Malignant tumors.
- With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- Contraindications to metformin (baseline creatinine >124μmol/L, hypersensitivity to metformin, or a metabolic acidosis), use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs)
- Pregnant.
- Mental diseases.
- Unwilling to comply with the research plan.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：vaginal repair + metformin
CSD patients were treated with vaginal repair of CSD in combination with metformin (Boke, 500 mg, Wanhui Shuanghe, Beijing, China) as an oral medicine (abbreviated as VR + metformin).
In the group of VR + metformin, the patients start oral metformin from one month before the operation to 6 months after the operation.
The dose is 500mg twice a day.
The detailed procedure of VR has been described in investigators' previous study.
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drug
其他名称：
The procedure of vaginal repair of CSD was shown as following.
The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached.
The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed.
A double layer of 1-0 absorbable interrupted sutures was used to close the incisions.
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有源比较器：vaginal repair
The procedure of vaginal repair of CSD was shown as following.
The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached.
The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed.
A double layer of 1-0 absorbable interrupted sutures was used to close the incisions.
|
The procedure of vaginal repair of CSD was shown as following.
The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached.
The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed.
A double layer of 1-0 absorbable interrupted sutures was used to close the incisions.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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剩余肌肉层厚度 (TRM) (mm)
大体时间：CSD阴道修复术后12周
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通过磁共振成像 (MRI) 测量剩余肌肉层的厚度
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CSD阴道修复术后12周
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月经持续时间（天）
大体时间：CSD阴道修复术后12周
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月经持续时间（天）
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CSD阴道修复术后12周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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thickness of the remaining muscular layer (TRM) (mm)
大体时间：24 weeks after vaginal repair of CSD
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The thickness of the remaining muscular layer is measured by MRI
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24 weeks after vaginal repair of CSD
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Duration of menstruation (day)
大体时间：24 weeks after vaginal repair of CSD
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Duration of menstruation (day)
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24 weeks after vaginal repair of CSD
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年2月1日
初级完成 (预期的)
2024年12月31日
研究完成 (预期的)
2025年6月30日
研究注册日期
首次提交
2022年1月11日
首先提交符合 QC 标准的
2022年1月24日
首次发布 (实际的)
2022年1月25日
研究记录更新
最后更新发布 (实际的)
2022年1月25日
上次提交的符合 QC 标准的更新
2022年1月24日
最后验证
2021年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.