An easy-to-use and convenient diagnostic home test for pregnant women has been proven to be as accurate as hospital tests – and could help save babies’ lives thanks to early diagnosis.
AmnioSenseTM is a new evidence-based test in the form of an advanced diagnostic polymer strip worn discreetly and comfortably inside a panty liner. It helps mothers-to-be to quickly, easily and accurately identify any amniotic fluid leaks – these can have potentially serious consequences for a pregnancy.
Around one in 10 pregnant women will have a premature rupture of the amniotic membrane  which protects the baby, and most will go into labour soon afterwards. Small tears can easily go undetected, leaving both mother and baby at risk of potentially life-threatening infections. Preterm ruptures are a factor in two out of five premature births .
Now the latest research published in the Midwifery Digest has highlighted the need for fast diagnosis of amniotic leaks or ruptures so that effective treatment can be put in place. Authored by Dr Paul Stillman, a general practitioner, and Emma Herbert, community midwife, this investigation confirms the potential for both saving babies’ lives and also reducing the financial burden on the NHS.
The authors of the research paper examined several studies in this latest review, all of which confirmed the accuracy, sensitivity and ease of use of AmnioSense.
The authors say: “If a leak of amniotic fluid is suspected, it must be investigated at once because both the mother and child may need immediate and expert attention. Maternal and neonatal morbidity can be reduced by the early detection of amniotic fluid leakage and appropriate management.
“Identifying an amniotic rupture quickly is the key to achieving the best outcomes so that effective treatment can be put in place.”
Commenting on the paper, family GP Dr Gill Jenkins says: “The potential benefits for the NHS of an at-home diagnostic tool, like AmnioSense reviewed in this research paper, could be immense. A single visit to an antenatal unit costs around £147. In this latest research review, data clearly shows that 38% of women who used AmnioSense did not have to attend an antenatal unit because they were able to confirm leaks were harmless. ”
Dr Jenkins adds: “Premature rupture of the amniotic sac is more common in women who have had a rupture in a previous pregnancy. Cervical surgery increases the risk of problems and women who are overweight or diabetic are also more likely to experience ruptures and leaks . The research shows that timely adoption of a convenient, clinically proven diagnostic tool such as AmnioSense provides reassurance and clear benefits for maternity and midwifery healthcare professionals and for pregnant women with possible amniotic rupture.”
HOW AMNIOSENSE WORKS
AmnioSense is a convenient diagnostic test that looks like an ordinary panty liner and avoids the discomfort and intrusion of a speculum examination.
AmnioSense liners include a central test strip which changes colour, and stays that way for at least two hours, when it comes into contact with amniotic fluid.
The initial reaction is triggered by liquid which has a pH of more than 6.5, which rules out some urinary leaks (the pH of urine ranges from 4.0 to 8). A second reagent in the strip reacts differently to ammonia, so any response caused by urine will fade after 10 minutes. Crucially, only two drops of fluid are needed to activate a result. Clinical trials have found the AmnioSense test as accurate as hospital-based examinations at detecting leaks of amniotic fluid.
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 panty-liner, alongside appropriate changes to clinical practice in the community, should be encouraged.
While many pregnant women are aware of the risks of amniotic rupture, it can be difficult to identify tiny leaks of amniotic fluid, and small leaks of urine — which are common as due date is approached— can easily be confused for something more serious. More than 20 per cent of pregnant women attend hospital reporting they feel wetness and around half are sent home after undergoing an internal examination to rule out a leak of amniotic fluid .
Community Midwife, Emma Herbert, who has been trialling the new test, says: “AmnioSense gives women 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.
“Another big advantage is that the panty-liner can be worn for up to 12 hours, making it 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.”
Premature rupture of the amniotic sac is more common in women who have had a rupture in a previous pregnancy. Cervical surgery increases the risk of problems and women who are overweight or diabetic are also more likely to experience ruptures and leaks.
The potential benefits for the NHS of the new test could be immense. 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 .
Dr Paul Stillman says: “There are around 695,000 live births in England and Wales every year, and around a third of those will notice some sort of leak — which adds up to a potential saving of £880,000, not to mention untold worry for both mothers and health professionals.”
 Bornstein J, Sdt et al. Non intrusive Diagnosis of Premature Ruptured Amniotic Membranes Using a Novel Polymer. Am J Pennatol 2006;23:1-4.
 Stillman P & Herbert E. Premature rupture of the amniotic sac: managing the risks. MIDRS. Midwifery Digest 27 (4) December 2017 pp 429-432.
 NICE review, on file
 Reported in a published summary of a congress of the obstetricians and gynaecologists
 NICE review, on file
 231,666 (3rd of 695,000) divided by 100 x 38