Improving Access to Abortion in the Republic of Georgia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Number of participants who report satisfactory experience
研究概览
简要总结
In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. Medication will be mailed along with two multi-level pregnancy tests to study participants, who will assess their abortion outcome at home.
详细描述
This prospective cohort study of patients obtaining medical abortion medications by mail. The study investigators aim to recruit approximately 120 patients for this study across three study sites that have extensive experience providing early medical abortion. Five days after undergoing in-person consultation and necessary exams to assess eligibility for medical abortion, study team will mail study participants medical abortion pills and two multi-level urine pregnancy tests. Medical abortion follow-up will occur at the participant's home approximately two weeks after the initial visit, and the multi-level pregnancy test will be used to assess abortion outcome. At follow-up, study participants will be asked questions about the results of the multi-level pregnancy test, and their experience and feedback about the acceptability of the process. At the conclusion of the study, investigators will interview providers to better undertand their experience with the simplified medical abortion service delivery model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women seeking medical abortion through 58 days gestation
- •Eligible for medical abortion according to study provider's assessment
- •Able to receive physical mail
- •Have access to a phone
- •Be willing and able to consent to participate in the study
- •Be willing to follow study procedures
排除标准
- •Not seeking medical abortion
- •Contraindications to medical abortion
研究组 & 干预措施
Medical abortion patients
Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone).
干预措施: Mifepristone (Drug)
结局指标
主要结局
Number of participants who report satisfactory experience
时间窗: Day 14 following initial medical abortion visit
Number of participants who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
Number of providers who report satisfactory experience
时间窗: End of the study, month 15
Number of providers who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
次要结局
- Number of participants with adverse event(Up to 6 weeks after initial medical abortion visit)
- Number of particpants with adverse event associated with mailing of medical abortion medications(Up to 6 weeks after initial medical abortion visit)
- Number of participants who refuse to receive medical abortion pills by mail(End of the study, month 15)
- Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure(Up to 6 weeks after initial medical abortion visit)
- Cost associated with the simplified medical abortion service delivery model(Up to 6 weeks after initial medical abortion visit)