Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 主要终点
- amniotic fluid leakage
研究概览
简要总结
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 or a "water breaking". 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. An additional, secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and specificity that are comparable to those specified for the currently marketed AMNIOTESTTM (nitrazine yellow swabs; PRO LAB Diagnostics) product.
详细描述
Baseline/ Screening
Potential subjects may undergo the informed consent process in the outpatient clinic.
Subjects 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. The clinician will explain the proper use and handling of the AL-SENSE and how to read the result. The participants will be provided with instructions for use and also directed to read the Instructions For Use (IFU) prior to applying the AL-SENSE pad.
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 used liner will be placed in a separate sealed envelope with the subject's ID and product name and protocol number on the outside.
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. The completed form will be placed in a sealed envelope with the subject's initials and study number on the outside.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and 45 years.
- •Subject minimum 16 weeks of pregnancy.
- •Who will sign the informed consent form.
- •Who arrive at the obstetric department reporting a feeling of vaginal wetness feeling undetermined whether this is amniotic fluid leakage or urinary incontinence).
排除标准
- •Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimester.
- •Subjects that have had sexual relations within the last 12 hours.
- •Subject is unable or unwilling to cooperate with study procedures.
- •Subject used the AL-SENSE before joining this study.
- •Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
- •Subject using vaginal products such as some douching formulas, some antibiotic treatments which reduce lactobacillus population.
结局指标
主要结局
amniotic fluid leakage
时间窗: day 1
The primary efficacy endpoints are: presence or absence of a blue- green stain on a yellow background as observed by the subject yielded by the AL-SENSE in addition to the binary clinical diagnosis (positive/negative), in order to assess the sensitivity and specificity of the AL-SENSE versus the standard clinical diagnosis.
次要结局
- result reading clarity(day 1)