PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND AS A HOSPITAL STANDARD OF CARE FOR AMNIOTIC FLUID LEAK DETECTION
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- AmnioSense performance
研究概览
简要总结
This is a Prospective study to demonstrate that the AMNIOSENSE Blue pad can reliably rule in or rule out amniotic fluid leak as a cause of vaginal wetness in pregnancy, thus, can be adopted by hospitals as an amniotic fluid leak detection tool, and can be recommended by care providers for use in a home usage setting.
Study Group 1: Women attending the triage / delivery room with unidentified will be provided with an AMNIOSENSE Blue pad to use in hospital until they notice any wetness prior to a clinical assessment as per hospital standard procedure.
The clinician performing clinical diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure will be at all times blinded to the results of the AMNIOSENSE Blue pad.
Study Group 2: Women attending the obstetrical antenatal clinic for a routine antenatal visit > 36+0, and has not been referred for further assessment in triage/delivery unit by the physician will recruited to this study group (Study Group 2). Before leaving the antenatal clinic, they will be given one AMNIOSENSE Blue pad to use at home when vaginal wetness is experienced or in any case when they suspect that they have amniotic fluid leakage. The participant will be instructed to arrive at the hospital within 2 hours of applying the AMNIOSENSE Blue pad, regardless of the test results (positive or negative), to have a clinical diagnosis by the attending physician.
详细描述
This is a Prospective study to demonstrate that the AMNIOSENSE Blue pad can reliably rule in or rule out amniotic fluid leak as a cause of vaginal wetness in pregnancy, thus, can be adopted by hospitals as an amniotic fluid leak detection tool, and can be recommended by care providers for use in a home usage setting.
Study Group 1: Women attending the triage / delivery room with unidentified wetness will be provided with an AMNIOSENSE Blue pad to use in hospital until they notice any wetness but for no longer than 2 hours prior to a clinical assessment as per hospital standard procedure.
The clinician performing clinical diagnosis tests (clinical assessment) for amniotic fluid leak detection, according to the hospital standard procedure will be at all times blinded to the results of the AMNIOSENSE Blue pad.
Clinical diagnosis of ROM and subsequent management of care will be determined as per clinicians' judgment using the standard hospital procedures of ferning and/or positive Nitrazine testing and/or sterile speculum examination.
The research team or attending nurse (non-bias to the subject's result record) will read the results of the AMNIOSENSE Blue pad, record the results in the data collection forms, and place the AMNIOSENSE Blue pad in a sealed envelope labeled with the study ID. These results will not be communicated to the attending clinicians who will remain blinded.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 and above.
- •Subject minimum 26+0 weeks of pregnancy.
- •Subject presents with feeling of vaginal wetness.
- •Age 18 and above
- •Subject minimum 36+0 weeks of pregnancy
- •Subject presents with a feeling of vaginal wetness, and has applied the AMNIOSENSE Blue pad prior to arriving at the triage/delivery unit
排除标准
- •Subject is unable or unwilling to comply with study procedures
- •Subject with active vaginal bleeding present at the time of admission to triage
- •Evidence of a non-reassuring fetal status at the time of assessment in triage (abnormal fetal heart tracing)
- •Subject has reported to have had sexual intercourse within the last 12 hours
研究组 & 干预措施
AmnioSense diagnostic pantyliner
AmnioSense diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods
干预措施: AmnioSense (Device)
结局指标
主要结局
AmnioSense performance
时间窗: 10 minutes
The primary efficacy endpoints are: presence or absence of a blue or green stain on a yellow background as confirmed by the study team yielded by the AMNIOSENSE Blue, compared to the "hospital standard procedure" - final clinical diagnosis (positive/negative) to assess the agreement between the subject/study team reading and final clinical diagnosis, in both study group 1 (hospital usage and 2 home usage).
次要结局
未报告次要终点