NCT00386867已完成不适用
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
Gynuity Health Projects8 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 8
- 主要终点
- efficacy
研究概览
简要总结
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •be willing and able to sign consent forms;
- •be eligible for medical abortion according to clinician's assessment;
- •be willing to undergo a surgical completion if necessary;
- •have ready and easy access to a telephone and emergency transportation;
- •speak English, Spanish, or have a translator available to translate for all study procedures; and,
- •agree to comply with the study procedures and visit schedule.
排除标准
- •Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- •IUD in place;
- •Chronic renal failure;
- •Concurrent long-term corticosteroid therapy;
- •History of allergy to mifepristone, misoprostol or other prostaglandin;
- •Hemorrhagic disorders or concurrent anticoagulant therapy;
- •Inherited porphyrias; or
- •Other serious physical or mental health conditions.
结局指标
主要结局
efficacy
次要结局
- acceptability
研究者
研究点 (8)
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