NCT02219100已完成不适用
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
Gynuity Health Projects5 个研究点 分布在 2 个国家目标入组 613 人开始时间: 2010年11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
- 613
- 试验地点
- 5
- 主要终点
- Proportion of abortions that are complete without surgical intervention (unit: percent).
研究概览
简要总结
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Good general health
- •Living or working close to the study site
- •Intrauterine pregnancy less than 64 days gestation
- •Willing and able to sign consent forms
- •Eligible for medical abortion according to the clinician's assessment
- •Ready access to a telephone and emergency transportation
- •Willing to provide an address 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
- •IUD in place (IUD must be removed first)
- •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
- •Other serious physical or mental health conditions
研究组 & 干预措施
Home administration of mifepristone
Experimental
This arm consisted of women who chose home administration of 200 mg mifepristone.
干预措施: Home administration of 200 mg mifepristone (Drug)
结局指标
主要结局
Proportion of abortions that are complete without surgical intervention (unit: percent).
时间窗: 15 days
Percentage of women with complete abortion without the need of a surgical intervention.
次要结局
- Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).(15 days)
研究者
研究点 (5)
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