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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
color change of the pantyliner in comparison to standard clinical diagnosis
Timeframe: 10 min