Vision Amniotic Leak Detector (ALD) to Eliminate Amniotic Fluid Leakage as a Cause of Vaginal Wetness in Pregnancy: A NICE Medical Technology Guidance

Abstract

In prelabour rupture of membranes (PROM) or preterm PROM the amniotic membranes rupture prior to labour. Where this is not overt a speculum examination is undertaken to confirm diagnosis. The Vision Amniotic Leak Detector (ALD) is a panty liner that can diagnose amniotic fluid as a cause of vaginal wetness. It was evaluated by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme. The sponsor (CommonSense Ltd) identified five studies, of which three were deemed within scope by the External Assessment Centre (EAC). Two of these three used an inappropriate comparator. The EAC recalculated the diagnostic accuracy of Vision ALD using speculum examination as the comparator: sensitivity of 97 % (95 % CI 93–99 %), negative predictive value of 96 % (95 % CI 92–98 %). A negative result would therefore allow patients to be discharged with confidence. In the sponsor’s cost-consequence model only patients with a positive Vision ALD result would have a speculum examination, producing a cost saving of around £10 per patient. The EAC felt that some costs were unjustified and the model did not include infection outcomes or use in a community setting. The EAC revised the sponsor’s model and found the results were most sensitive to clinician costs. Vision ALD was associated with savings of around £15–£25 per patient when administration in lower-cost community healthcare avoided a referral to a higher-cost secondary-care centre. NICE published guidance MTG15 in July 2013 recommending that the case for adopting Vision ALD was supported by the evidence.

Women's expectations and experiences of rupture of membranes and views of the potential use of reagent pads for detecting amniotic fluid

“…Such reagent pads have been recommended as a means of reducing more invasive methods such as speculum examination (Ray et al, 2015) that women may find embarrassing, stressful and painful (Seehusen et al, 2006). However, women's views of the use of reagent pads do not appear to have been reported previously.…”

“…The use of a reagent pad to confirm rupture of membranes has been tested among a group of women reported as being mainly at high obstetric risk (Mulhair et al, 2009). Such reagent pads have been recommended as a means of reducing more invasive methods such as speculum examination (Ray et al, 2015) that women may find embarrassing, stressful and painful (Seehusen et al, 2006). However, women's views of the use of reagent pads do not appear to have been reported previously.…”

“…However, further testing of sensitivity and specificity was recommended (Alto and Cooper, 2005, Bornstein et al, 2009, Mulhair et al, 2009. Such pads are now becoming available and midwives encouraged to explore their use with women, particularly as a means of reducing unnecessary referrals and speculum examinations (Ray et al, 2015).…”

Development of a RPA-CRISPR-Cas12a Assay for Rapid, Simple, and Sensitive Detection of Mycoplasma hominis

“…Recent studies have shown that M. hominis infection is associated with premature birth, malformation, and even death of the fetus, resulting in seriously adverse consequences for pregnant women and babies (Michou et al, 2014;Kersin et al, 2020;Ansari et al, 2021;Paira et al, 2021). Hence, the early detection of the infection may reduce maternal and neonatal morbidity (Ray et al, 2015).…”