A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipas
- 入组人数
- 4,196
- 试验地点
- 2
- 主要终点
- Need for additional treatment to complete abortion
研究概览
简要总结
The goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.
详细描述
Medical abortion with mifepristone and misoprostol within the first 10 weeks of pregnancy is safe and highly effective. Investigators aim to assess whether self-use of early (<9 weeks) medical abortion using mifepristone with misoprostol results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medical abortion.
The investigators will prospectively recruit women who obtain medical abortion medication from pharmacies and clinics. Follow-up will occur by telephone during two phone calls within 30 days following the woman's abortion. A small number of adolescents will be recruited into a qualitative substudy.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women are eligible for participation if they have purchased abortion medications (mifepristone-misoprostol) independently at a pharmacy or received them from a clinic for an unwanted pregnancy at less than 9 weeks since her last menstrual period (LMP). She must meet the following criteria:
- •Be at least 15 years of age (may vary by country)
- •Have a known LMP of less than 9 weeks
- •No contraindications to medical abortion (list)
- •Willing and able to give informed consent
- •Have a mobile phone of which they are the independent user or be willing to be followed-up in person
- •Willing to be contacted with questions about her abortion by telephone (optional in-person visit) at 3, 10-14 and 30 days following initial contact.
- •Resident of country of study.
- •Exclusion criteria:
- •Contraindications to mifepristone-misoprostol
排除标准
- 未提供
结局指标
主要结局
Need for additional treatment to complete abortion
时间窗: Final assessment at 30 days following mifepristone administration
The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol) following a woman taking the medical abortion pills.
次要结局
- Serious complications/ morbidity(Final assessment at 30 days following mifepristone administration)