NCT02985229已完成3 期
Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation
Gynuity Health Projects2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Rate of successful abortion
研究概览
简要总结
To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have an intrauterine pregnancy consistent wit gestational age ≤ 70 days
- •Be 21 years of age or over
- •Be willing and able to sign consent forms
- •Be eligible for abortion according to current hospital guidelines
- •Be able to return to the clinic and able to contact study staff or emergency medical services if needed
- •Be willing to provide an address, email and/or telephone number for purposes of follow-up
- •Agree to comply with the study procedures and visit schedule
排除标准
- •confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- •chronic renal failure
- •concurrent long-term corticosteroid therapy
- •history of inherited porphyrias
- •IUD in place (must be removed after mifepristone is administered).
研究组 & 干预措施
All participants
Experimental
All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion.
干预措施: Mifepristone (Drug)
All participants
Experimental
All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rate of successful abortion
时间窗: 7-10 days after mifepristone administration
Proportion of abortions that are complete without surgical intervention
次要结局
- Preferred location of mifepristone administration(The day of enrollment)
- Satisfaction with the medical abortion method(7-10 days after mifepristone administration)
研究者
研究点 (2)
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