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临床试验/NCT01150422
NCT01150422已完成3 期

The Acceptability and Feasibility of an Alternative to a Routine Follow-up Visit After Medical Abortion in Vietnam

Gynuity Health Projects4 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2010年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1,500
试验地点
4
主要终点
Continued, ongoing pregnancy

研究概览

简要总结

This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.

The goal of the study is to provide answers to the following questions:

  1. Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?
  2. Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
  3. Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?

研究设计

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

入排标准

年龄范围
13 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Reproductive age women seeking medical abortion services
  • Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
  • Hold a working, personal phone number
  • be willing and able to sign consent forms and agree to comply with study procedures

排除标准

  • Pregnancy greater than 63 days gestation on the day of mifepristone administration

结局指标

主要结局

Continued, ongoing pregnancy

时间窗: 9 months

次要结局

  • percentage of women who return for follow-up(9 months)
  • percentage of women receiving other treatment for ongoing pregnancy(9 months)

研究者

发起方
Gynuity Health Projects
申办方类型
Other

研究点 (4)

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