New technology makes diagnosing SROM much simpler

New technology makes diagnosing SROM much simpler

New technology is now available to healthcare professionals for reliably excluding SROM/PROM/P-PROM without invasive speculum testing – AMNIOSENSE.

AmnioSense is a two-stage diagnostic polymer strip within the comfortable and familiar format of a panty liner, that can tell if a pregnant woman is leaking amniotic fluid. As accurate as hospital-based examinations (sterile speculum examination, ferning test and pH test), AmnioSense in two out of five cases enables an accurate diagnosis without the need for a physical examination of the cervix using a speculum [1].

Unlike hospital-based tests, AmnioSense allows continuous monitoring and detects minute leaks. AmnioSense is so sensitive it reacts to as little as 100 microlitres of amniotic fluid, the equivalent of two drops [2].

Until now, the only way to diagnose the problem has been using a speculum and a swab test. AmnioSense could help 42 per cent of patients to avoid a speculum examination, giving significant patient benefits.

Guidance from NICE is unequivocal: “The early detection of leaking amniotic fluid, and appropriate management, may lead to a reduction in maternal and neonatal morbidity.” Clinical studies and independent evaluation by NICE (National Institute for Health and Clinical Excellence), have all confirmed the accuracy and effectiveness of AmnioSense. NICE concluded that using the liners, alongside appropriate changes to clinical practice in the community, should be encouraged.

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AMNIOSENSE – HOW DOES IT WORK?

AmnioSense looks like an ordinary panty-liner. However, what is different with AmnioSense is the fact that it includes a strip which turns blue-green when it comes into contact with moisture with a pH — a measure of alkalinity or acidity — of more than 6.5. Amniotic fluid has a pH of 6.7 or more while normal vaginal secretion ranges from 3.5 to 4.5.

The pH of urine can vary from 4.0 to 8 [3], but it also contains ammonia. As a result, AmnioSense includes reagents which react differently to ammonia. This helps eliminate any false positives caused by incontinence. If the liner changes colour due to urine, it will then fade within 10 minutes. The test area will remain a blue-green colour for at least two hours when the reaction has been triggered by amniotic fluid.

 

TIMINGS AND TREATMENTS

Having intimate leaks is incredibly common in pregnancy and it can be difficult to determine whether it’s leaking urine, vaginal discharge or leaking amniotic fluid. This can be very frightening for many women and others wrongly assume they’re leaked urine when there is actually a more urgent need for attention and action. For healthcare professionals in primary and community settings, there has been no choice but to refer women to the hospital for testing. Now with AmnioSense there is a much more convenient, unobtrusive and less costly alternative.

Commenting on the introduction of AmnioSense, Community Midwife, Emma Herbert says: “AmnioSense gives women that control by providing a simple, effective, trustworthy and non-invasive test which allows them to differentiate between a pregnancy niggle and a potentially serious pregnancy complication.

“For professionals, AmnioSense gives the reassurance that a leak is not caused by amniotic fluid, without the need for an intimate exam. In addition, as the panty liner can be worn for up to 12 hours, it is very efficient at detecting small, slow leaks of amniotic fluid. And as the results are stable for at least two hours there is often time for the woman to get to her midwife or doctor and show them the results.”

 

COST SAVINGS

AmnioSense could also save the NHS money in terms of hospital visits and external examinations. A NICE review pointed out, a single visit to an antenatal unit costs £147 and research shows that 38 per cent of women who used AmnioSense did not have to attend because they were able to confirm leaks were harmless [4]. Dr Paul Stillman adds: “There are around 695,000 live births in England and Wales every year [5], and around a third of those will notice some sort of leak [6] — which adds up to a potential saving of £880,000 [7], not to mention untold concern.”

AmnioSense_Front_Carton_Highres AmniosensePads_Diagram

 

FACTS & STATS

Premature rupture of membranes (PROM) occurs in around 10 per cent of pregnancies. When this happens before 37 weeks, it is known as preterm premature rupture of membranes (P-PROM) and this occurs in one in 50 pregnancies. Symptoms can easily be confused with urinary incontinence (affecting one in three pregnant women [8]) or increased vaginal discharge. P-PROM is associated with 40 per cent of preterm deliveries and can lead to significant morbidity and mortality.

 

REFERENCES

  1. NICE review, on file
  2. http://www.unitconversion.org/volume/microliters-to-drops-conversion.html
  3. https://medlineplus.gov/ency/article/003583.htm
  4. NICE review, on file
  5. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/livebirths/bulletins/birthsummarytablesenglandandwales/2015-07-15
  6. http://www.csp.org.uk/your-health/conditions/pregnancy-related-incontinence
  7. 231,666 (3rd of 695,000) divided by 100 x 38
  8. Chartered Society of Physiotherapy and Royal College of Midwives

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