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临床试验/NCT02614781
NCT02614781已完成不适用

Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

Nordic Pharma SAS1 个研究点 分布在 1 个国家目标入组 892 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
892
试验地点
1
主要终点
success rate of the protocol Mifegyne and prostaglandin analogue

研究概览

简要总结

This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers.

The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women (≥ 18 years old) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy
  • Patients for whom the physician decides to use a Mifegyne 600 mg and prostaglandin analogue combination for medical abortion
  • Patients agreeing to participate in the study after having been informed orally by the physician and given the information sheet
  • Informed patients accepting the computer processing of their medical data and their right of access and correction

排除标准

  • Patients with known hypersensitivity to mifepristone
  • Patients with known hypersensitivity to prostaglandin analogues (misoprostol or gemeprost).
  • Patients with severe and progressive disease
  • Patients with ectopic pregnancy

结局指标

主要结局

success rate of the protocol Mifegyne and prostaglandin analogue

时间窗: At the follow-up at 2-3 weeks after inclusion

The success rate will be defined as complete abortion without surgical procedure

次要结局

  • rate of ongoing pregnancy by term.(at the follow up at 2-3 weeks after the inclusion)
  • Number of medical abortion using misoprostol(at the follow up at 2-3 weeks after the inclusion)
  • Evaluation by patients of pain using a 5 level verbal rating scale(at the follow up at 2-3 weeks after the inclusion)
  • rate of patients requiring any additional procedures by term.(at the follow up at 2-3 weeks after the inclusion)
  • Success rate of the protocol Mifegyne and misoprostol per os.(at the follow up at 2-3 weeks after the inclusion)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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