Prospective Non Interventional Phase IV Multi-centre Canadian Study on the Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion Under 63 Days Gestation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 6
- 主要终点
- Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days of gestational age
研究概览
简要总结
National multi-center non interventional study aiming at investigating the effectiveness and safety of the combination mifepristone-misoprostol prescribed in Canada to women for medical termination of pregnancy at or before 63 days gestational age through a multi-center prospective non interventional study design.
详细描述
Primary Objectives:
- Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age, defined as complete abortion without further intervention within 14 days of mifepristone administration
- Safety of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age, defined as the rate of significant Treatment Emergent Adverse Events (TEAE) as a composite outcome of the following events: 1. Hospital Admission; 2. Treatment in Emergency Room; 3. Blood Transfusion; 4. Infection requiring IV Antibiotics, Admission, or Surgical debridement; 5. Death; 6. Ongoing intrauterine pregnancy; 7. Ectopic pregnancy.
Secondary objectives:
- To determine the rate of ongoing pregnancy within 14 days after the administration of mifepristone
- To determine the rate of surgical aspiration performed at the follow-up and time since mifepristone administration
- To determine the reasons for surgical aspiration
- To evaluate the follow-up rate
- To evaluate the delay between the scheduled and actual treatment administration
- To determine the overall safety profile of mifepristone-misoprostol combination
- To evaluate the impact of the demographic characteristics (prescription site, region, gestational age) on effectiveness and safety
- To evaluate the impact of gestational age on effectiveness and safety
- To evaluate the impact of treatment self-administration on effectiveness and safety
- To evaluate the impact of the method and timing of determining gestational age on effectiveness and safety
Study population:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- 未提供
排除标准
- •Participant who is unable to understand or comply with Health Care Professional instructions or medical abortion regimen
- •Participant who is unable or unwilling to provide written informed consent.
结局指标
主要结局
Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days of gestational age
时间窗: 14 to 28 days
Defined as complete abortion without further intervention within 14 days of mifepristone administration.
Safety of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age
时间窗: 14 to 28 days
Defined as the rate of significant Treatment Emergent Adverse Events (TEAE) as a composite outcome of the following events: 1. Hospital Admission; 2. Treatment in Emergency Room; 3. Blood Transfusion; 4. Infection requiring IV Antibiotics, Admission, or Surgical debridement; 5. Death; 6. Ongoing intrauterine pregnancy; 7. Ectopic pregnancy.
次要结局
- Rate of ongoing pregnancy(14 to 28 days)
- Rate of surgical aspiration(14-28 days)
- Reasons for surgical aspiration(14-28 days)
- Delay between the scheduled and actual treatment administration(14 days)
- Overall safety profile of mifepristone-misoprostol combination(14-28 days)
- Impact of the demographic characteristics on effectiveness and safety(14-28 days)
- Impact of gestational age on effectiveness and safety(14-28 days)
- Impact of treatment self-administration on effectiveness and safety(14-28 days)
- Impact of the method and timing of determining gestational age on effectiveness and safety(14-28 days)
- Follow-up rate(28 days)