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NICE consults on new device for assessing a pregnancy complication which affects thousands of women

The National Institute for Health and Clinical Excellence (NICE) today (20 March), opens a consultation on its draft medical technology guidance on 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 draft NICE guidance supports the case for adopting the Vision Amniotic Leak Detector (Vision ALD) as a means to reliably exclude 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 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 in urine) is present. 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 causing vaginal wetness in pregnancy, avoiding the need for a speculum examination. There are estimated cost savings of up to £24 per woman compared with current management. The estimated 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 sponsor claims that the device benefits the woman 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's 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.

"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. Using the device is estimated to save the NHS up to £24 per woman compared to standard management. 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.

"We are keen to receive comments on the draft guidance as part of this consultation, particularly from midwives, obstetricians, other antenatal health care professionals and groups representing pregnant women."

More information on the medical technology draft guidance consultation for Vision ALD is available on the NICE website. The consultation closes on 19 April 2013.

ENDS

Notes to Editors

About the guidance

1. The draft medical technologies guidance, Vision Amniotic Leak Detector to assess unexplained vaginal wetness in pregnancy, is available on the NICE website from 20 March 2013.

2. The Vision Amniotic Leak Detector (Vision ALD) is manufactured by CommonSense Ltd.

3. When issued by a midwife or other healthcare worker in a general practice setting, cost savings per woman of up to £24.01 (for prelabour rupture of membranes; PROM, pregnancies over 37 weeks' gestation) and £18.25 (for premature prelabour rupture of membranes; PPROM, pregnancies under 37 weeks' gestation) could be achieved, through avoiding the need for referral to an antenatal day unit. When issued by a community midwife in a woman's home, Vision ALD is associated with an estimated cost saving of up to £21.01 per woman for PROM and £15.25 per woman for PPROM.

4. The cost of the Vision ALD stated in the sponsor's submission is £1.60 per test.

5. Current management of suspected amniotic fluid leakage requires the woman to lie on a hospital bed for 30 minutes before the procedure, so that any leaking amniotic fluid can collect in the vagina. After this time, a doctor or midwife will use a speculum to examine the vagina for pooling of amniotic fluid. If pooling is seen, the woman is diagnosed with ruptured membranes and her condition managed accordingly, as recommended in Intrapartum care (NICE clinical guideline 55).

6. There were 807,776 live births in the UK in 2011. (Office for National Statistics, Dec 2012, )

About the Medical Technologies Evaluation Programme

7. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available on the NICE website.

About NICE

8. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

9. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
  • social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.

10. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
  • CCG Outcomes Indicator Set (formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure improvements in the quality of care for patients and communities served by the clinical commissioning groups (CCGs).

11. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates high quality guidance and evidence-based information to help professionals deliver the best patient care through NHS Evidence.

This page was last updated: 19 March 2013

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