The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of women who have undergone a successful abortion
研究概览
简要总结
These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.
Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Seeking abortion services
- •Have an intrauterine pregnancy 78 days through 84 days' LMP
- •Be willing and able to sign consent forms
- •Agree to comply with study procedures and visit schedule
- •Be living with 30 minutes from the hospital
排除标准
- •Does not meet the inclusion criteria outlined above
研究组 & 干预措施
Misoprostol at clinic
Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home.
Participants will be asked to return to the hospital 14 days later for a follow-up visit.
干预措施: Misoprostol (Drug)
Misoprostol at clinic
Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home.
Participants will be asked to return to the hospital 14 days later for a follow-up visit.
干预措施: Mifepristone (Drug)
结局指标
主要结局
Percentage of women who have undergone a successful abortion
时间窗: 2 weeks
次要结局
- Women's acceptability of the assigned method.(2 weeks)
- Side effects(48 hours)