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临床试验/NCT06747598
NCT06747598已完成不适用

Efficacy Evaluation of Using Finger Stick Peripheral Blood for Point of Care Pregnancy Testing

University of Nebraska1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Number of Participants With Positive POC Serum Pregnancy Test

研究概览

简要总结

To evaluate the efficacy of using peripheral blood for POC pregnancy testing in known pregnant participants.

详细描述

Point of care (POC) pregnancy tests are designed for use with a urine specimen. However, the timely collection of a urine specimen is solely dependent on the patient's need to urinate which can delay the initiation of subsequent care activities. Furthermore, when considering the limitations of urine POC testing in wilderness scenarios, collecting a urine specimen from an injured person may not be a viable option. The literature has demonstrated blood as a viable alternative specimen for use with POC pregnancy testing with a sensitivity of 95.8%. Based on a literature review, these studies used blood specimen that were pre-collected into a serum collection vial. The study postulates the use of peripheral blood via a finger stick has multiple benefits such as 1) eliminating the need to wait for urine, 2) expedite the serum collection process as compared to a venipucture, 3) allow for testing in non-traditional scenarios such as wilderness medicine or mass casualty/gathering scenarios, and 4) minimizing the amount of blood required as compared to a traditional 3-5 ml serum collection vial. Data from this pilot study will provide valuable insight on the potential use of this testing method to inform future studies and treatment protocols for the above mentioned scenarios.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Pregnant female, 19 years or older, being seen at the Nebraska Medicine OB/GYN clinic

排除标准

  • •Does not meet inclusion criteria

研究组 & 干预措施

POC serum pregnancy test arm

Enrolled participants will provide a peripheral serum specimen for POC pregnancy testing

干预措施: pregnancy test (Diagnostic Test)

结局指标

主要结局

Number of Participants With Positive POC Serum Pregnancy Test

时间窗: One time test at time of enrollment

A peripheral serum sample was collected through a finger stick point-of-care (POC) test to assess pregnancy in 30 women with previously confirmed pregnancies. The results were reported as either positive or negative.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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