NCT00870272已完成不适用
A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Gynuity Health Projects1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2007年7月最近更新:
适应症
干预措施
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
- 550
- 试验地点
- 1
- 主要终点
- Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration
研究概览
简要总结
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of <63 days will be offered the option of participating in the study.
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
- •Gestational age less than or equal to 63 days
- •General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
- •Willing to provide an address and/or telephone number for purposes of follow-up.
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
研究组 & 干预措施
1
Active Comparator
400mcg sublingual misoprostol
干预措施: Misoprostol (Drug)
2
Active Comparator
400mcg buccal misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration
时间窗: July 2007-March 2009
次要结局
- Side effects experienced(July 2007- March 2009)
研究者
研究点 (1)
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