Clinical trial NCT03177135: PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND HOSPITAL
Official title: PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND AS A HOSPITAL STANDARD OF CARE FOR AMNIOTIC FLUID LEAK DETECTION
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amniotic Problems
Lead sponsor: Common Sense
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

In each case, the subject will also be required to read and record any occurrence of color change of the AMNIOSENSE Blue 10 minutes after removing the test on the designated form.

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 participants will be provided with instructions for use and also instructed to read the Instructions For Use (IFU) prior to applying the AMNIOSENSE Blue pad. They will be instructed to only apply the AMNIOSENSE Blue pad when they are planning to attend the triage/delivery unit for assessment of wetness/leaking. 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.

Upon arrival to the triage/delivery unit, the participant and the attending nurse or research team member (non-bias to the subject's result record) will retrieve the AMNIOSENSE Blue pad and record the results in the designated 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.

In each case, the subject will also be required to read and record any occurrence of color change of the AMNIOSENSE Blue 10 minutes after removing the test on the designated form.

While in the hospital, participants will be managed according to standard hospital procedure at the discretion of the clinician and have clinical diagnostic tests (clinical assessment) for amniotic fluid leak detection, according to the hospital standard procedure. The clinician will be blinded to the results of the AMNIOSENSE Blue during the study, and as such subject treatment will be based only on the standard hospital diagnostic methods.

Eligibility criteria: Inclusion Criteria:

Group 1:

* Age 18 and above.
* Subject minimum 26+0 weeks of pregnancy.
* Subject presents with feeling of vaginal wetness.

Group 2:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: AmnioSense performance
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Amanda Amanda, MD
role: PRINCIPAL_INVESTIGATOR
References: