Assessing Acceptability and Use of Medical Menstrual Regulation in the United States
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Number of participants who report that MMR was acceptable or highly acceptable during the exit interview
研究概览
简要总结
This study will assess the acceptability and use of medical menstrual regulation among women in the United States.
详细描述
Medical menstrual regulation (MMR) entails the use of uterine evacuation medications by women with late menses without confirming pregnancy status. Provision of MMR in the United States could expand reproductive choice and service options for women. This study will collect data on the acceptability, efficacy, safety and feasibility of MMR among women with missed menses of 1-21 days
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
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-49 years
- •General good health
- •Does not want to be pregnant
- •Does not want to verify pregnancy status at the study site
- •History of regular monthly menstrual cycles
- •Missed menses of 1-21 days
- •Sexual activity in the past 2 months
- •Willing and able to sign consent forms
- •Willing to provide urine sample at enrollment
- •Willing to return for a follow-up visit
排除标准
- •Known allergies or contraindications to mifepristone and/or misoprostol
- •Symptoms of or risk factors for ectopic pregnancy
- •Current use of an IUD, contraceptive implant or injectable
研究组 & 干预措施
Medical menstrual regulation
Mifepristone 200 mg orally on day 1.
Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).
干预措施: Mifepristone (Drug)
Medical menstrual regulation
Mifepristone 200 mg orally on day 1.
Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).
干预措施: Misoprostol (Drug)
结局指标
主要结局
Number of participants who report that MMR was acceptable or highly acceptable during the exit interview
时间窗: Up to 28 days after mifepristone administration
Acceptability of MMR
次要结局
- Number of participants with adverse events and/or side effects(Up to 28 days after mifepristone administration)
- Number of participants not pregnant at follow-up(Up to 28 days after mifepristone administration)
- Perceived advantages and disadvantages of MMR as reported by participants during the exit interview(Up to 28 days after mifepristone administration)