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