Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of participants that are followed through the study
研究概览
简要总结
In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.
详细描述
In this study, the investigators propose to conduct a parallel study to the MA-ASAP pilot study (ClinicalTrials.gov Identifier: NCT05278780) at one or more independent abortion clinics. This new study will be similar in structure to pilot study, except that all completed screening questionnaires will be sent to the study site rather than only those deemed eligible according a computer algorithm. The investigators expect that this change will better serve the needs of both clinics and patients, and it will also allow us to assess whether the algorithm is overly restrictive, i.e., whether it is excluding patients who are in fact eligible for MA. The primary goal of the study is to collect data on feasibility of the approach and safety. Secondarily, the investigators aim to assess the ability of a defined set of responses to the screening questionnaire to predict the clinician's decision about whether a clinical consultation is needed.
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
- •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 old enough to consent to abortion and study participation without parental consent in the study state
- •Has reviewed the study website
- •Has had a positive pregnancy test
- •Has signed the study informed consent form (ICF), which will be included within the questionnaire
- •Is pregnant with a gestational age of ≤77 days from last menstrual period
- •Desires MA
- •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 not asked by the site to have a synchronous consultation with clinician OR facility-based tests such as ultrasound, laboratory tests, examination, etc.
- •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
结局指标
主要结局
Proportion of participants that are followed through the study
时间窗: 6 months
The numbers and proportions of people who complete the questionnaire once initiated, are reached by study staff after submitting a completed questionnaire, and are ultimately followed through the study.
Study site satisfaction (self-reported)
时间窗: 6 months
Interest on the part of study sites to continue to utilize this approach to MA provision after the study ends.
Incidence of Treatment-Emergent Adverse Events
时间窗: 6 months
Proportion of treated participants with SAE related to the study
Incidence of participant questions
时间窗: 6 months
The proportion of participants who have questions after completing the questionnaire and the types of questions that are asked.
Incidence of reported problems by site staff
时间窗: 6 months
Problems with the study process as reported by site staff
次要结局
- Efficacy of computer algorithm to determine MA eligibility(6 months)