AmnioSense for unexplained vaginal wetness in pregnancy

The technology described in this briefing is AmnioSense. It is used for identifying leaking amniotic fluid in pregnant women with unexplained vaginal wetness.

The innovative aspects are that AmnioSense is a non-invasive test that uses a pH‑dependent colour changing strip to identify amniotic fluid. The test can be used in a clinical or home environment.

The intended place in therapy would be as well as standard care in pregnant women with unexplained vaginal wetness.

The main points from the evidence summarised in this briefing are from 4 studies: 1 observational study and 3 repeated measures comparative studies including a total of 729 pregnant women in a clinical setting. They show that AmnioSense is as effective as standard care in identifying amniotic fluid in women with unexplained vaginal wetness.

Key uncertainties around the evidence or technology are the lack of studies comparing the current version of the technology with standard care. There are also no published studies to show equivalence between the current and previous versions of the technology.

The cost of AmnioSense is £1.59 per unit (exclusive of VAT). The resource impact would be greater than standard care. The technology may be capacity releasing because of a shift from secondary care to primary and community care but there are no published studies to support this claim.