A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen
试验速览
- 阶段
- 不适用
- 发起方
- Ipas
- 入组人数
- 4,000
- 试验地点
- 1
- 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 misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.
详细描述
Medication abortion with a misoprostol-only regimen within the first 10 weeks of pregnancy is safe and effective. Investigators aim to assess whether self-use of early (<9 weeks) medication abortion using a misoprostol-only regimen results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medication abortion.
The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.
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 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Purchased a misoprostol-only abortion regimen at a PMV or from a clinic
- •Be at least 15 years of age
- •Have a known LMP of less than 9 weeks
- •No contraindications to medical abortion
- •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 at 1-3, 10-29 and 30-45 days following initial contact.
排除标准
- •Contraindications to misoprostol
- •Age <15 or >49
结局指标
主要结局
Need for additional treatment to complete abortion
时间窗: Final assessment at 45 days following misoprostol
The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol \>3 doses) following a woman taking the medication abortion pills.
次要结局
- Serious complications/ morbidity(Final assessment at 45 days following misoprostol)