Medical Abortion Via Telemedicine for Women and Adolescents in Moldova
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 549
- 试验地点
- 1
- 主要终点
- Successful termination of pregnancy without adverse events
研究概览
简要总结
This study evaluates the safety, feasibility, and acceptability of a novel medical abortion via telemedicine service in the Republic of Moldova.
详细描述
Women and girls in Moldova, especially those in rural areas, must travel to regional medical centers to obtain an abortion from a certified gynecologist. This creates barriers to accessing safe abortion that disproportionately affect poor women and girls, through wage loss due to missed work and accrued costs due to transportation. This innovation is a novel service delivery model that allows self-management of medical abortion (MA) with remote guidance from a provider. After confirming their pregnancy, women seeking MA will receive counseling from a gynecologist via videoconference and will subsequently obtain the necessary medication via mail or at at participating pharmacy with prescription. Follow-up will occur 1 weeks later via phone/videoconference (with referral to a doctor if necessary) to confirm MA success and assess the patient's and provider's satisfaction with the service. We hope to demonstrate the feasibility, effectiveness and acceptability of telemedicine MA services in Moldova so that it can thus be integrated into the national public healthcare system. As a result, this project will serve as a model that could be adapted and implemented in nearby countries within the Eastern Europe and Central Asia region.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •16 years or older
- •Has an unwanted pregnancy
- •Confirmed the pregnancy using a test or via ultrasound
- •Gestational age of 9 weeks or less
- •Has personally decided to end the pregnancy
- •Has a device (phone, tablet, or computer) with internet connection, a webcam, and a microphone.
- •Has immediate access to emergency services
- •Reports no contraindication to medical abortion
排除标准
- •Under 16 years of age
- •Does not have an unwanted pregnancy
- •Did not confirm pregnancy
- •Gestational age greater than 9 weeks
- •Does not have a device (phone, tablet, or computer) with internet connection, a webcam, and a microphone
- •Does not have immediate access to emergency services
- •Has an intrauterine device
- •Is allergic to abortion medications (mifepristone or misoprostol)
- •Has severe anemia or acute porphyria
- •Has a condition that affects the ability of blood to clot normally
- •Has hepatic failure or chronic renal disease
- •Has an ectopic pregnancy
- •Has heart disease or other cardiovascular problem
- •Has a condition that requires hormone treatment
研究组 & 干预措施
Women and girls seeking abortion.
干预措施: Medical abortion (Drug)
结局指标
主要结局
Successful termination of pregnancy without adverse events
时间窗: through study completion, around 15 months
Percentage of study participants that successfully terminate their pregnancy via the telemedicine medical abortion model without experiencing any adverse events.
次要结局
- Participant satisfaction with the medical abortion via telemedicine service(through study completion, around 15 months)
- Cost savings experienced by study participants(through study completion, around 15 months)
- Provider satisfaction(through study completion, around 15 months)