Assessing the Acceptability of Using Misoprostol Alone for Menstrual Regulation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Interest in missed period pills
研究概览
简要总结
The Missed Period Pill Study is a prospective observational study among people who decide to use misoprostol alone for menstrual regulation.
详细描述
As the number of state laws restricting access to abortion increases across the country, more creative methods are needed to support individuals in achieving their reproductive goals. Misoprostol alone for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. The goal of this research study is to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to "bring back" a period when it is missed. This study will aim to recruit 100 patients who have a missed period to address research questions that focus on the feasibility and acceptability of using misoprostol alone for menstrual regulation.
The study will require 1 study visit and 1 telehealth visit.
First study visit: A urine sample will be collected which will later undergo pregnancy testing. Participants will be given misoprostol along with instructions and information on what to expect. The participant will be required to return to the clinic 4 weeks later to provide another urine sample. The participant will not know the results of the first visit's pregnancy test at any point. The clinic staff member administering the participant's care will not know of the pregnancy test result while the participant is at the clinic.
Telehealth visit: The second visit will be by phone or video. The participant will conduct a pregnancy test and inform the research staff of the result. The participant will then be asked to answer questions on an online survey about their experience using misoprostol.
A variety of clinical and social science measures will be collected to assess the feasibility and acceptability of this traditional concept of menstrual regulation utilizing uterine evacuation with medications.
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 14 days
- •Have had regular periods in the last 4-6 months
- •Does not want to be pregnant; understand that if they are pregnant, the pills will end their pregnancy
- •Be willing to have an abortion if the missed period pill does not work, and informed of potential for birth defects in any ongoing pregnancy
- •Does not want to verify pregnancy status
- •Does not have risk factors for ectopic pregnancy (history of ectopic pregnancy, recent vaginal bleeding or spotting, pelvic pain on one side, prior permanent contraception, or other tubal surgery)
- •Does not have an IUD
- •Does not currently use a contraceptive implant or injectable
- •Does not have contraindications to misoprostol
- •Agree to participate in the follow up visit/call
排除标准
- •Participants who have contraindications to misoprostol
- •Unknown date of last menstrual period
- •Risk factors for ectopic pregnancy (history of ectopic pregnancy, recent vaginal bleeding or spotting, pelvic pain on one side, prior permanent contraception, or other tubal surgery)
- •Irregular menses or any other condition that in the opinion of the Principal Investigator would compromise participant safety.
研究组 & 干预措施
Study participants
Study participants will be persons who have late period of up to 14 days
干预措施: Misoprostol (Drug)
结局指标
主要结局
Interest in missed period pills
时间窗: Documented at Enrollment Survey
The proportion of the clinic-going population that may be interested in a missed period pill and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy.
Satisfaction with missed 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 missed period pills on a five-point Likert scale at 4 weeks.
次要结局
- Efficacy of missed period pills(Documented at the second study visit, through study completion at around 4 weeks after drug adminstration)