NICE consults on new device for assessing pregnancy complications

Research suggests Vision ALD device can detect cause of potentially-serious vaginal wetness

The draft NICE guidance suggests using Vision ALD could increase the chance of detecting a potentially serious amniotic leak in pregnancy

The National Institute for Health and Clinical Excellence (NICE) this weeks opened a consultation on its draft medical technology guidance on the use of an innovative device to assess the potentially-serious complication of unexplained vaginal wetness in pregnancy.

The wetness could simply be leaking urine, which is not a cause for immediate concern, but it could also be leaking amniotic fluid, which would indicate that the fetal membranes have ruptured, with the potential for infection to occur.

The draft NICE guidance supports the case for adopting the Vision Amniotic Leak Detector (Vision ALD) as a means of reliably excluding a leak of amniotic fluid as a cause.

The committee concluded that the most likely benefit would be from using the Vision ALD in primary care settings as this would avoid unnecessary referrals to secondary care services, such as an antenatal day unit or maternity triage area, releasing resources and clinical time in these busy departments

The Vision ALD, manufactured by Sutherland Health Group, is a diagnostic panty liner that can be attached to underwear. The device is issued by a midwife or other healthcare professional and is then worn by the woman for up to 12 hours, before the liner is then placed in a drying unit.

The indicator strip in the liner changes colour depending on the pH of the fluid causing the wetness, and whether ammonia, which is present in urine, is detected. If the indicator strip is yellow after drying, then the leak is unlikely to be amniotic fluid and a speculum examination can be avoided. If the indicator strip is blue-green after drying, this indicates the wetness is likely to be amniotic fluid or infection, which can then be confirmed by a speculum examination and a vaginal swab.

The available evidence suggests that the device can exclude an amniotic fluid leak as the cause, with estimated cost savings of up to £24 per woman compared with current management. The saving depends on whether the pregnancy has reached 37 weeks gestation or if it is earlier, and whether the device is issued at a general practice or at the woman’s home by a community midwife. In addition, the device benefits women by avoiding a potentially-unnecessary speculum examination and associated risk of infection, a reduction in time spent in hospital, and incidental detection of possible vaginal infection.

The Vision ALD is intended for use by women with normal pregnancies experiencing unexplained vaginal wetness and by those at high risk of premature rupture of membranes.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “It is important to distinguish whether unexplained vaginal wetness in pregnancy is due to amniotic fluid leaking, or if it’s due to urine, which is far less of a worry. Leaking amniotic fluid is estimated to occur in 6% -19% of full-term pregnancies, and around 2% of premature pregnancies, so between 64,000 and 170,000 pregnant women could be affected in the UK each year.

Leaking amniotic fluid is estimated to occur in 6% -19% of full-term pregnancies, and around 2% of premature pregnancies, so between 64,000 and 170,000 pregnant women could be affected in the UK each year

“The independent Medical Technologies Advisory Committee (MTAC) considered that there was evidence to support the use of the Vision ALD when it is provided to women at their general practice or by their community midwife. The committee concluded that the most likely benefit would be from using the Vision ALD in primary care settings as this would avoid unnecessary referrals to secondary care services, such as an antenatal day unit or maternity triage area, releasing resources and clinical time in these busy departments.

“The device is also more convenient for patients as it avoids potentially-unnecessary speculum examinations, which are invasive and can carry a risk of infection.”

As part of the consultation, NICE is seeking comments from midwives, obstetricians, other antenatal healthcare professionals and groups representing pregnant women.”

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