Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 622
- 试验地点
- 4
- 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 the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.
详细描述
The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.
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
- •At least 18 years old
- •In 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
- •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
Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
干预措施: Home administration of 200 mg mifepristone (Drug)
Home administration of mifepristone
Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
干预措施: Home or clinic administration of 400 mcg buccal misoprostol (Drug)
Clinic administration of mifepristone
Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
干预措施: Home or clinic administration of 400 mcg buccal misoprostol (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)