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临床试验/NCT01410266
NCT01410266已完成4 期

The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan

Gynuity Health Projects7 个研究点 分布在 2 个国家目标入组 2,400 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
2,400
试验地点
7
主要终点
Continued, ongoing pregnancy

研究概览

简要总结

The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.

详细描述

Medical abortion using mifepristone and misoprostol is a highly effective procedure, but access to it may be impeded by the fact that not all women can afford or want to return for a follow-up visit. This often results in a high loss to follow-up rate. Additionally, with medical abortions of those women who do return for follow-up, higher costs are borne by both the woman and the healthcare system.

This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.

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
16 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Reproductive-age woman seeking a medical abortion
  • Woman in good general health
  • Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
  • Woman able and willing to sign consent forms
  • Woman eligible for medical abortion according to clinician's assessment
  • Woman agreeing to be followed up with, by phone or at a clinic visit

排除标准

  • Woman with a 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: 1 month

次要结局

  • Percentage of women who return for follow-up(1 month)
  • Percentage of women receiving other treatment for ongoing pregnancy(1 month)

研究者

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

研究点 (7)

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