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临床试验/NCT02933190
NCT02933190Unknown不适用

Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy

Shanghai First Maternity and Infant Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Duration of menstruation by questionnaire (days)

研究概览

简要总结

To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

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(24). 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 (days)

时间窗: six months after treatment

Endocrine level by blood examination (FSH in IU/L)

时间窗: six months after treatment

Volume of menstruation by questionnaire (in pictorial blood loss score)

时间窗: six months after treatment

次要结局

  • The length of the CSD by MRI (millimeter)(six months after treatment)
  • The depth of the CSD by MRI (millimeter)(six months after treatment)
  • The width of the CSD by MRI (millimeter)(six months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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