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临床试验/NCT01811056
NCT01811056已完成不适用

Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion

Gynuity Health Projects3 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
401
试验地点
3
主要终点
Proportion of participants who would recommend outside-of-center administration to a friend

研究概览

简要总结

This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.

详细描述

This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Women 18 years and older
  • seeking medical abortion services
  • in general good health
  • assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken
  • eligible for medical abortion according to clinician and center standards.

排除标准

  • will be followed up by beta HCG and not ultrasound

研究组 & 干预措施

Out-of-Center Use of Mifepristone

Experimental

Participants who choose to take the mifepristone outside of the center

干预措施: Mifepristone (Drug)

结局指标

主要结局

Proportion of participants who would recommend outside-of-center administration to a friend

时间窗: 1-2 weeks

Proportion of participants who would choose outside of center administration of mifepristone again

时间窗: 1-2 weeks

次要结局

  • Proportion of women who select outside-of-clinic use of mifepristone(1-2 weeks)
  • Adherence(1-2 weeks)
  • Success Rates/Method Failure(1-2 weeks)
  • Provider-related outcomes(1-2 weeks)

研究者

发起方
Gynuity Health Projects
申办方类型
Other
责任方
Sponsor

研究点 (3)

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