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:
- 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 .
- To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical.
- 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
- 是
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
研究点 (11)
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