Medication Abortion With Autonomous Self-Assessment Project: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service.
详细描述
In this study, the investigators propose to create and pilot-test an asynchronous medication abortion (MA) provision service. The foundation of this service will be a website that provides information combined with a linked screening questionnaire. The questionnaire will be designed to collect the information recommended by current MA guidelines for history-based MA eligibility assessment. If the patient's responses meet specified criteria, the questionnaire will be sent to a study clinician, who will then determine whether a real-time clinical consultation or facility-based tests are needed. If the clinician decides that they are not, treatment will be provided accordingly. The primary goal of the study is to collect preliminary data on feasibility of the approach, abortion outcomes, and participant satisfaction. The investigators will use these data to determine whether to proceed with further development of asynchronous MA provision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •• Has reviewed the study website
- •Can speak and read English
- •Has an address in a state where the study clinicians are licensed to practice medicine and where the service is legal
- •Is at least 18 years old
- •Is pregnant with a gestational age of ≤54 days from last menstrual period
- •Desires MA
- •Has not had an ultrasound in the current pregnancy (see below)
- •Has no symptoms of or risk factors for ectopic pregnancy
- •Has no medical contraindications to MA, specifically:
- •Hemorrhagic disorder or concurrent anticoagulant therapy
- •Chronic adrenal failure
- •Concurrent long-term systemic corticosteroid therapy
- •Inherited porphyria
- •Allergy to mifepristone or misoprostol, or other prostaglandin
- •Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider.
排除标准
- 未提供
研究组 & 干预措施
Asynchronous screening
Participants will be screened for medication abortion eligibility using written or online materials and questionnaires, without a synchronous conversation between the prescribing clinician and the patient.
干预措施: Screening for eligibility (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 12 months
Proportion of treated participants with SAE (serious adverse effects) related to the study
次要结局
- Incidence of participant questions(12 months)