Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation
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
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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-
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Ho Chi Minh City、越南
- Hung Vuong Hospital
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Does not meet the inclusion criteria outlined above
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percentage of women who have undergone a successful abortion
大体时间:2 weeks
|
2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Women's acceptability of the assigned method.
大体时间:2 weeks
|
2 weeks
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Side effects
大体时间:48 hours
|
Side effects include nausea, vomiting, pain, diarrhea, fever.
Asked women to rank as none, mild, moderate, severe.
Used an acceptability scale (Very Acceptable v. Acceptable v. Neutral v. Unacceptable v. Very unacceptable v. Don't know) to ascertain acceptability among women
|
48 hours
|
合作者和调查者
调查人员
- 首席研究员:Nguyen Thu Nhu Ngoc, MD、Center for Research and Consultancy in Reproductive Health
- 首席研究员:Dina F Abbas、Gynuity Health Projects
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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