AmnioSense - Further Clinical Studies

Another study reviewing AmnioSense compared results from 103 women, aged 18 to 45, attending the labour and delivery ward of a university-affiliated hospital in Israel. A third had suspected leaks, rupture was confirmed in another third and the remaining third had no symptoms and provided a control group.*   Of the 34 women with suspected leaks, rupture of the membranes was confirmed in 10 cases and everyone was correctly identified by the AmnioSense panty-liner.

The investigators concluded that AmnioSense is: “A highly sensitive, non-intrusive method for use in ruling out the possibility of PROM. It is also capable of differentiating PROM from urinary incontinence or vulvo-vaginal candidiasis, thereby avoiding misdiagnosis, unnecessary treatment, and interventions, which reduces patient anxiety and lowers costs.”

Of six ‘false’ positives identified in the AmnioSense group, four were found to have bacterial vaginosis and two went into labour shortly after speculum examinations.

The investigators concluded that AmnioSense is: “A highly sensitive, non-intrusive method for use in ruling out the possibility of PROM. It is also capable of differentiating PROM from urinary incontinence or vulvo-vaginal candidiasis, thereby avoiding misdiagnosis, unnecessary treatment, and interventions, which reduces patient anxiety and lowers costs.”

The studies identify several potential applications for AminoSense including using it in triage, to identify ‘leaks’ caused by urinary incontinence or increased vaginal secretions associated with fungal or bacterial infections, and to reserve speculum examination only for those women who have a positive result using the AmnioSense test.

As the NICE technology appraisal points out, this would avoid 42% of the speculum examinations currently carried out to determine whether or not there is a rupture of the membranes.

*Bornstein J Nonintrusive Diagnosis AL-SENSE Am J Printol 2006 on file

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