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临床试验/NCT07288307
NCT07288307尚未招募2 期

Ultrasound Guided Surgical Evacuation Versus Combined Local and Systemic Methotrexate Injection for Management of Caesarean Scar Pregnancy [Clinical Trial ]

Minia University0 个研究点目标入组 42 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
42
主要终点
Success rate of treatment either by surgical evacuation or by methotrexate injection

研究概览

简要总结

The aim of the study is to compare the effectiveness and the complications of Ultrasound guided surgical evacuation versus using combined local and systemic methotrexate injection for management of caesarean scar pregnancy.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestation age Less than 12 weeks. Hemodynamically stable patient with un ruptured CSP. Non disturbed scar pregnancy . Acceptance of possible prolonged follow up, repeated HCG tests, the need for additional treatment doses and possible bleeding and subsequent hysterectomy.

排除标准

  • Patient refuse TOP. Gestation age More than 12 weeks . Hemodynamically unstable patient with ruptured CSP. Contraindication for methotrexate as hepatic disorders, renal disorders ,hypersensitivity to the drug and autoimmune diseases.

结局指标

主要结局

Success rate of treatment either by surgical evacuation or by methotrexate injection

时间窗: Up to 8 weeks post -intervention

The proportion of participants achieving complete resolution of caesarean scar pregnancy without the need of additional intervention

次要结局

  • Uterine perforation.(Up to 8 weeks post -intervention)
  • Bleeding during the procedure(Up to 8 weeks post -intervention)
  • The need for additional intervention(Up to 8 weeks post -intervention)
  • Time for serum-hCG normalisation (days).(Up to 8 weeks post -intervention)
  • Hospital stay (days).(Up to 8 weeks post -intervention)
  • Occurrence of drug complications(Up to 8 weeks post -intervention)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Badr Atef Abd Allah Moussa

Badr Atef

Minia University

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