Period Pills for Menstrual Regulation: A New Reproductive Health Option
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Interest in period pills
研究概览
简要总结
The Period Pills Study is a prospective observational study among people who decide to use a combination of mifepristone and misoprostol for menstrual regulation.
详细描述
Period pills (a combination of mifepristone and misoprostol) for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. In the United States (U.S.), a handful of providers currently offer period pills alongside other contraceptive and abortion services in their practice (https://www.periodpills.org/providers). This proposed study would aim to assess the acceptability of this growing service as a fertility regulation method to be utilized before a person confirms they are pregnant.
Dr. Ushma Upadhyay (Professor) and Dr. Tania Serna (Associate Clinical Professor) at UCSF's Department of Obstetrics, Gynecology & Reproductive Science are proposing the Period Pills Study to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to "bring back" a period when it is late, or missed. This study will aim to recruit 100 participants who have a late period to address research questions that focus on the feasibility and acceptability of using period pills for menstrual regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be 18 years old or older
- •Read and speak English
- •Know the date of their last menstrual period within 2 days
- •Have a period that is late by up to 21 days
- •Must have had regular periods in the last 4 months
- •Does not want to be pregnant
- •Does not want to verify pregnancy status
- •Understand that if they are pregnant, the pills will end their pregnancy
- •Does not have contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
排除标准
- •Under 18 years old
- •Does not read and speak English
- •Does not know the date of their last menstrual period within 2 days
- •Has not had regular periods in the last 4 months
- •Wants to be pregnant
- •Wants to verify pregnancy status
- •Does not display understanding that if they are pregnant, the pills will end their pregnancy
- •Has any contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
研究组 & 干预措施
Study Participants
Study participants will be persons who have late period of up to 21 days
干预措施: Mifepristone + Misoprostol (Drug)
结局指标
主要结局
Interest in period pills
时间窗: Documented at Enrollment Survey
The proportion of the clinic-going population that may be interested in a period pill to bring on a late period and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy.
Satisfaction with period pills
时间窗: Documented at Follow-up Survey, 4 weeks after drug administration
The proportion of participants reporting being "satisfied" or "very satisfied" with the period pills on a five-point Likert scale at follow-up (4 weeks).
次要结局
- Efficacy of period pills(Documented at the follow-up visit, through study completion at around 4 weeks after drug administration.)
研究者
Ushma Upadhyay
Principal Investigator
University of California, San Francisco