Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration of menstruation by questionnaire
研究概览
简要总结
Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D&C in the treatment of CSP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.
排除标准
- •All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
结局指标
主要结局
Duration of menstruation by questionnaire
时间窗: six months after treatment
Duration of menstruation
Endocrine level by blood examination
时间窗: six months after treatment
FSH in IU/L
Volume of menstruation by questionnaire
时间窗: six months after treatment
in pictorial blood loss score
次要结局
- The length of the CSD by MRI(six months after treatment)
- The depth of the CSD by MRI(six months after treatment)