Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- thickness of the remaining muscular layer (TRM) (mm)
研究概览
简要总结
GnRH-a will be used to postpone period after vaginal repair for Cesarean Section Scar Defect（CSD） patients with adenomyosis which will be compared with CSD patients with adenomyosis who receive transvaginal surgery without GnRH-a, whether delayed period improving the CSD prognosis will be assessed.
详细描述
Women with CSD complicated with adenomyosis will be enrolled in this study. They all will receive vaginal excision and suture of CSD and will be required to undergo examinations at 6-months after surgery.
Interventioned group will be subcutaneous injected of Leuprorelin to postpone period after vaginal repair. It is be assumed that temporary menopause could improve inner conditions of uterus, there would be less local inflammation reaction which would be beneficial to the scar healed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clearly diagnosed with CSD complicated with adenomyosis
- •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).
- •uterine fibroids no more than 5cm
- •Sign the informed consent.
排除标准
- •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).
- •Mental diseases.
- •Allergy to the any ingredients of Leuprorelin
- •Unwilling to comply with the research plan.
研究组 & 干预措施
Vaginal Repair without Leuprorelin
The detailed procedure of Vaginal Repair has been described in our previous study.
Vaginal Repair with Leuprorelin
CSD patients were treated with vaginal repair of CSD in combination with Leuprorelin . In the group of Vaginal Repair With Leuprorelin, the patients will get 3 times of Leuprorelin per 4 weeks perioperation. The detailed procedure of Vaginal Repair has been described in our previous study.
干预措施: Leuprorelin (Drug)
结局指标
主要结局
thickness of the remaining muscular layer (TRM) (mm)
时间窗: 12 weeks after vaginal repair of CSD
The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)
Duration of menstruation (day)
时间窗: 12 weeks after vaginal repair of CSD
Duration of menstruation (day)
次要结局
未报告次要终点