Can Midlevel Providers Manage Medical Abortion in the Second Trimester as Safely and Effectively as Physicians? A Randomized Controlled Trial in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipas
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Time to expulsion
研究概览
简要总结
The purpose of the study is to determine the safety and effectiveness of second trimester medical abortion when provided by nurse midwives compared with physicians. The study sample will be obtained from Michu Clinic, affiliated with St Paul's hospital, in Addis Ababa.
详细描述
About 10% of all abortions globally take place at or after 13 weeks gestation. Women seeking second-trimester abortion services are often the most vulnerable and socially disadvantaged population.Studies show the rate of second-trimester abortion procedures remains stable over time, even in high-access locations, confirming the ongoing need for accessibility to services in rural locations with limited access to care. In Ethiopia, second-trimester abortion services are widely available in Addis Ababa, making up a high proportion of the total number of abortions occurring each year in the country; however, access to accurate and reliable data is limited.
The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system (WHO abortion guidelines). Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct second trimester aspiration abortions is proposed as a way to increase women's access to safe abortion procedures and has been highlighted by the WHO as an area in which rigorous research is needed (WHO task-sharing guidelines).
The investigators seek to conduct a comparative study of patients undergoing second trimester medical abortion provided by either physicians or nurse midwives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Willing and able to give consent for participation
- •Intrauterine pregnancy with confirmed gestational age >13 weeks and <20 weeks
- •Presenting for induced abortion at Michu Clinic
- •Speaker of Amharic or Oromo
排除标准
- •Women unable to give consent for participation
- •Gestational age <13 or >20 weeks
- •Adolescents aged less than 16 years
- •Women with an allergy to or contraindications to mifepristone or misoprostol
- •Women with a history of more than one previous hysterotomy
- •Women seeking treatment for incomplete abortion, intrauterine fetal demise, or postabortion care
- •Women with chronic hypertension or adrenal failure
- •Women on chronic steroid treatment
结局指标
主要结局
Time to expulsion
时间窗: Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours
Time to expulsion of fetus after medical abortion regimen initiated
次要结局
- Need for intervention by a physician(Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days))
- Need for ultrasound to confirm gestational age(At the time of eligibility for the abortion is assessed, need for confirmatory ultrasound recorded (up to 1 day))
- Total number of misoprostol doses(Time (hours/minutes) from first dose of misoprostol until the fetus and placenta are expelled, up to 72 hours)
- Serious complications/ morbidity(Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days))
- Adverse events(up to 7 days after discharge)