- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965430
PERFORMANCE STUDY OF THE AL-SENSE
This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence.
Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any wetness.
The blinded physician will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.
Study Overview
Detailed Description
This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence. Subjects arriving at the hospital and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE.
In each case, the blinded clinician will be required to read and record any occurrence of color change of the AL-SENSE 10 minutes after the AL-SENSE removal and to mark if it changes color to blue or to green on the designated form.
The blinded physician (other than the clinician who records the AL-SENSE results) will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.
In cases where the AL-SENSE shows positive results but the clinical assessment results are negative, reference laboratories, or any other standard procedure will check for the possibility of BV or Trichomonas in addition to the tests noted above.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years or greater.
- 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).
Exclusion Criteria:
- Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimesters.
- Subjects that have had sexual intercourse within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AL-SENSE diagnostic pantyliner
AL-SENSE diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods.
|
A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
color change of the pantyliner in comparison to standard clinical diagnosis
Time Frame: 10 min
|
presence or absence of a blue or green stain on a yellow background as observed by the clinician yielded by the AL-SENSE in addition to the binary clinical diagnosis
|
10 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liangkun Ma, MD, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- F-7-32.4-5.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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