UK’s NICE Guidance Supports New Device for Assessing a Pregnancy Complication Which Affects Thousands of Women
Newly issued guidance from the UK’s National Institute for Health and Care Excellence (NICE) supports the use of a 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, or it could be leaking amniotic fluid, which would indicate that the fetal membranes had ruptured, with the potential for infection to occur.
The NICE guidance backs midwives and other healthcare staff providing the Vision Amniotic Leak Detector (Vision ALD) as a way of reliably excluding a leak of amniotic fluid as a cause of vaginal wetness in pregnancy. The Vision ALD is a diagnostic panty liner that can be attached to underwear. The pregnant woman wears it for up to 12 hours and it is then assessed by the health professional. Colour changes in the Vision ALD indicate whether the wetness is due to amniotic fluid, urine or if further tests are needed to check for infection. This device can avoid women having a potentially unnecessary speculum examination, which can cause discomfort.
Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “This new guidance on use of the Vision ALD is good news both for pregnant women who experience unexplained vaginal wetness and for the NHS. The evidence considered shows that the device can reliably distinguish whether unexplained vaginal wetness in pregnancy is due to amniotic fluid leaking, or if it’s due to urine which is less of a concern. The guidance recommends that midwives and other healthcare professionals provide the Vision ALD to pregnant women experiencing this complication. This avoids the need for the woman to have an unnecessary speculum examination which is invasive and often uncomfortable.
“It’s estimated that in the UK each year, between 64, 000 and 170,000 pregnant women experience rupture of membranes prior to labour. Using the device in the community could prevent unnecessary referrals to secondary care antenatal day units or maternity triage services for speculum examinations – this will free up clinical time and resources and is estimated to save the NHS up to £24 per woman compared to standard management.”
The estimated savings of up to £24 per woman compared with current management 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. 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.