Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening in the Second and Third Trimesters of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Color change of pantyliner surface compared to standard clinical diagnosis
研究概览
简要总结
This is a Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments. Pregnant women attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness.
Product Usage
After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal and to mark if it changes color to blue or to green or not on the designated form. The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension. A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment). The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test and/or positive results in both the pH test and the Ferning test will be defined as a positive clinical test result.
详细描述
This study is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage .
The AL-SENSE is an extended shelf-life product that is technically simple, fast to react, visually readable, and therefore enables women to test the cause of any unidentified wetness, before confirmation by a physician.
Principles of operation:
Vaginal fluids are discharged over time and collected on the non-intrusive panty liner. If the user observes a blue or green stain, the result of the test is positive. The AL-SENSE polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value.
The AL-SENSE will indicate that the pH level is elevated when the level is equal or greater than 6.5. This choice of 6.5 units as the cutoff level will limit the cases of false positive and will reduce unnecessary alarm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Screening/ Baseline inclusion criteria for subject participation in the study at baseline assessment are pregnant women age 18 and above who have completed minimum 16 weeks of pregnancy are eligible for the study. Subject attending the labor and delivery unit of the hospital or emergency clinic or outpatient clinic and reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence)
排除标准
- 未提供
研究组 & 干预措施
Single arm Al-Sense diagnostic
Investigator blinded to subject assessments
干预措施: Al-Sense (Device)
结局指标
主要结局
Color change of pantyliner surface compared to standard clinical diagnosis
时间窗: 10 minutes
Color change
次要结局
- Subject vs. Clinician reading of liner color change(up to 48 hours)
- Questionnaire to assess subject comprehension of usage criteria and subjective experience(15 minutes)