Evaluation of Telemedicine Services to Address Urgent Issues Related to Sexual and Reproductive Rights in Ecuador
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Adverse events (safety)
研究概览
简要总结
This research seeks to demonstrate that a telemedicine model for the provision of legal abortion services in Ecuador is safe, feasible and acceptable to users requesting a medication abortion and who are less than 12 weeks pregnant.
详细描述
The purpose of this observational study is to pilot and evaluate the remote provision of medication abortion as part of a telemedicine service that promotes the sexual and reproductive rights of Ecuadorian women. The study aims to enroll 100 participants who contact private sector providers in Ecuador to obtain a medication abortion.
The telemedicine service will be designed to incorporate the standard steps in an in-person medical abortion procedure to ensure that the quality of care provided to each participant is equal to that which one would otherwise receive during visits to a clinic.
Specific objectives include:
- Document interest in the telemedicine model among users who wish to receive a medication abortion with private study providers.
- Document the benefits and disadvantages of the remote care approach perceived by users and providers.
- Document compliance with the requirements established for the provision of telemedicine service for medication abortion within the context of this study.
- Document any obstacles encountered in meeting the requirements of the telemedicine protocol.
Initial-contact and screening for eligibility: Women who contact the study clinic to request a medical abortion and who meet the basic eligibility criteria to terminate their pregnancy using the remote approach will be informed that the study provider offers such an option as part of an investigation. Individuals who express interest in the telemedicine service and are determined as likely to be eligible will have a "TelEvaluation" set up with the study provider, who will give standard pre-abortion counseling (via telephone, video conferencing, etc) and explain the study procedures and process of obtaining informed consent for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman is seeking abortion care and wants to use telemedicine service for her medication abortion procedure.
- •Woman has access to an internet connection or a device that allows remote consultation.
- •Woman is 15 years of age or older.
- •Woman can provide an address to which abortion medications will be mailed.
- •Woman reports having no contraindications to a medical abortion.
- •The study provider does not suspect ectopic pregnancy or a nonviable pregnancy.
- •The gestational age allows sufficient time for the woman to take the misoprostol no later than 84 days of gestation.
- •A feasible plan is made that the woman agrees to confirm complete abortion and to seek care to manage incomplete abortion complications.
- •The woman understands the study procedures and is likely to comply with study instructions and has granted informed consent to participate in the study.
排除标准
- •Medically ineligible for procedure.
- •Provider determines that a medical abortion using the telemedicine approach is not appropriate for that person.
研究组 & 干预措施
early medication abortion via telemedicine
Medication abortion up to 84 days gestation using misoprostol alone regimen consisting of three doses 800mcg (4 tablets of 200mcg misoprostol each) taken every 3 hours. An extra dose (800mcg) may also be taken if there was no bleeding after administering the earlier doses.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Adverse events (safety)
时间窗: 6 weeks
Incidence of adverse events among those who self-administered medication abortion regimen
次要结局
- Feasibility of telemedicine service(6 weeks)
- Acceptability of telemedicine service(6 weeks)