Point of Care Testing for Human Chorionic Gonadotropin (HCG) to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Sensitivity
研究概览
简要总结
This study will investigate the use of a point of care test in patients who are having an abortion at a gestation of <6 weeks (known as a very early medical abortion). These patients have pregnancy hormone level checked at Day 0 and Day 7 to see if treatment has worked. The investigators plan to use a point of care test machine to see if it is possible to check pregnancy hormone level earlier than Day 7.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Positive pregnancy test
- •Less than six weeks gestation based upon Last Menstrual Period (LMP)
- •No evidence of definite intrauterine pregnancy on ultrasound
- •No signs or symptoms or significant risk factors for ectopic
- •Wish to proceed to VEMA (Very Early Medical Abortion)
- •Available for usual clinical follow up
- •Willing to attend for serum Human Chorionic Gonadotropin (HCG) on two occasions Day 2-4 and Day 7 post mifepristone
- •Written informed consent
排除标准
- •Pain and/or bleeding
- •Significant risk factors for ectopic (previous ectopic, sterilisation, tubal disease, intrauterine device in situ)
- •Suspicious features for ectopic on ultrasound (adnexal mass, moderate free fluid)
- •Unable to provide blood sample
- •Lack of Capacity to consent
研究组 & 干预措施
Staff Members
Staff members involved in using the point of care test
干预措施: Participant Questionnaire (Other)
VEMA Patients
Women & Gender diverse individuals meeting clinical requirements for having very early medical abortion
干预措施: Blood test (Diagnostic Test)
VEMA Patients
Women & Gender diverse individuals meeting clinical requirements for having very early medical abortion
干预措施: Participant Questionnaire (Other)
结局指标
主要结局
Sensitivity
时间窗: Day 0, Day 2-4 and Day 7
Sensitivity of percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day2-4 compared with percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day 7
Specificity
时间窗: 7 days
The Specificity of percentage HCG drop between Day 0 and Day 2-4, compared with specificity of percentage HCG drop between Day 0 and Day 7
次要结局
- Usability questionnaire for Human Chorionic Gonadotropin (HCG) POCT verification using Likert scale.(1 year)
- Likert Scales(1 year)
- Positive Predictive Value (PPV)(4 days)
- Negative Predictive Value (NPV)(4 days)
- Binary Outcome(7 days)