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临床试验/NCT01150279
NCT01150279已完成不适用

Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up

Gynuity Health Projects11 个研究点 分布在 4 个国家目标入组 1,200 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,200
试验地点
11
主要终点
Percent of women who correctly interpreted their results (in U.S. and Vietnam only)

研究概览

简要总结

This study will examine the feasibility, acceptability and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early medical abortion using mifepristone+misoprostol. The study seeks to:

  1. Assess the feasibility of using this test in lieu of standard one-week clinic-based follow up for determination of complete abortion status as part of normal service delivery. In Mexico, follow up will be in two weeks, as is standard care in that .
  2. To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical.
  3. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of clinic-based follow up for confirmation of complete medical abortion in the future.

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 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women age greater than or equal to 18 years
  • Gestational age less than or equal to 63 days by last menstrual period (LMP), ultrasound or clinical assessment
  • Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up
  • Able to consent to study participation.
  • Inclusion Criteria for Mexico:
  • Gestational age <_ 70 days from LMP
  • Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines
  • Willing to follow instructions of the provider regarding use of the at-home pregnancy test
  • Agrees to provide test results by phone to study coordinator on morning of schedule follow-up visit
  • Willing to provide an address and/or telephone number for purposes of follow-up
  • Agrees to return for standard follow-up visit
  • Wishes to participate in the study
  • Having easy access to a telephone and transportation
  • Able to consent to study participation

排除标准

  • Women less than 18 years of age
  • Women not eligible for medical abortion services
  • Women unable to provide contact information
  • Women unable to sign the consent form
  • Exclusion Criteria for Mexico:
  • Women not eligible for medical abortion services
  • Women unable to provide contact information
  • Women unable to sign the consent form

结局指标

主要结局

Percent of women who correctly interpreted their results (in U.S. and Vietnam only)

时间窗: 18 months

次要结局

  • The proportion of times the provider believes that each participant correctly read her test result(18 months)
  • Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up(18 months)
  • The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies(18 months)
  • Percent of women who felt confident in using the test and would be willing to use it in place of clinic-based follow up in the future(18 months)

研究者

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

研究点 (11)

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