Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Successful medical abortion
研究概览
简要总结
This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D&E will be performed to complete the abortion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
- •Meet legal criteria to obtain abortion
- •Be at least 18 years old
- •Have access to a phone where she can be reached for the 2-week follow up
- •Be willing to follow pilot study procedures
排除标准
- •Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- •Any contraindications to vaginal delivery
- •More than one prior cesarean delivery
- •Staying more than 2 hours away from the clinic
研究组 & 干预措施
Mifepristone and misoprostol
Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion.
干预措施: Mifepristone (Drug)
Mifepristone and misoprostol
Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Successful medical abortion
时间窗: 0-60 hours after mifepristone
Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.
次要结局
- Induction-to-abortion interval(0-12 hours after misoprostol)
- Initiation-to-abortion interval(0-60 hours after mifepristone)
- Total clinic time(0-12 hours from arrival at clinic on day of induction with misoprostol)
- Pain with procedure(0-12 hours after first misoprostol dose)
- Tasks performed by clinic staff(From enrollment through discharge from care (approx. 3 days))
- Total dose of misoprostol administered(0-12 hours after misoprostol)
- Satisfaction with procedure(Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose)
- Method safety(Two weeks after mifepristone)
- Side effects(0-12 hours after first misoprostol dose)