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临床试验/NCT05028387
NCT05028387已完成不适用

Safety and Acceptability of a Telemedicine Medical Abortion Service Using the "No-test" Protocol In Ukraine and Uzbekistan.

Gynuity Health Projects4 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2021年9月1日最近更新:
适应症
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
250
试验地点
4
主要终点
Incidence rate of adverse events resulting from remote provision of medical abortion

研究概览

简要总结

The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

详细描述

The goal of this study is to pilot and evaluate a telemedicine medical abortion (TMA) service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Providers will provide counseling by phone or video about pregnancy options and give detailed information about the medical abortion process, expected side effects, and where to seek additional care. The provider will then evaluate the woman's eligibility for TMA service by following the no-test protocol and discuss at-home follow-up using a symptom checklist and a high-sensitivity urine pregnancy test. If pre-treatment tests are needed, women will be referred to a nearby diagnostic center and test results will be forwarded to the study provider. Participants will receive medications by mail or courier service or pick them up at the pharmacy or study clinics, take medications as instructed, and complete at-home follow-ups as discussed with the provider.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site)
  • Has no contraindications to medical abortion
  • Has access to a phone
  • Is able to take mifepristone on or before 63 days gestation

排除标准

  • Medically ineligible for medical abortion
  • Gestational age above 63 days based on LMP

结局指标

主要结局

Incidence rate of adverse events resulting from remote provision of medical abortion

时间窗: 6 weeks

Adverse events such as regimen non-compliance or medically unnecessary interventions associated with remote provision of medical abortion.

次要结局

  • Satisfaction with remote provision of medical abortion(6 weeks)

研究者

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

研究点 (4)

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