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临床试验/NCT03461653
NCT03461653已完成不适用

Efficacy of Medical Abortion Through Telemedicine Versus Standard Provision - a Randomised Controlled Non-inferiority Trial

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 1,598 人开始时间: 2018年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,598
试验地点
2
主要终点
Proportion of women with complete abortion

研究概览

简要总结

The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to medical abortion provided traditionally following face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate whether counselling through telemedicine is non-inferior to face-to face counselling a RCT will be conducted including women who chose medical abortion up to 63 days of gestation with home administration of misoprostol and self assessment of the outcome. The results of this study could be of major importance to increase access to safe and acceptable abortion services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at < /=63 days of gestation, no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent

排除标准

  • women who do not want home administration of misoprostol, women who are unable to communicate in Swedish, or English, and women with symptoms and signs of ectopic pregnancy.

结局指标

主要结局

Proportion of women with complete abortion

时间窗: 30 days of abortion treatment

Efficacy of medical abortion defined as complete abortion without ongoing intrauterine pregnancy or surgical intervention for incomplete abortion within 30 days of the abortion treatment.Reported by the patient in the follow up questionnaire and by assessment of patient records

次要结局

  • Proportions of women who would chose the same mode of provision in case of a future medical abortion(30 days)
  • Rate of reported complications that require additional treatment.(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Gemzell Danielsson

Professor

Karolinska Institutet

研究点 (2)

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