Effectiveness of a Novel Home-Based Testing Device for the Detection of Rupture of Membranes

Abstract

We evaluated the ability of a testing panty liner (TPL) embedded with a pH/ammonia indicator polymer to differentiate amniotic fluid leakage from urine. A multicenter, open-label study in which 339 pregnant women (age 18 to 45 years, minimum 16 weeks' gestation, presenting with unexplained vaginal wetness) were enrolled. The TPL was worn and the results read by the subject and a health care provider (HCP) who was blinded to the subject's reading. Results were compared with the standard clinical diagnosis, as determined by direct visualization of vaginal pooling, crystallization (ferning), and nitrazine tests, performed by a second blinded HCP. Subject experience with the test was assessed with a brief questionnaire. The TPL accurately detected 154 of the 161 subjects found to have amniotic fluid leakage by the standard diagnosis; thus, the sensitivity of the TPL was 95.65%. The specificity was 84.46% (% true negative readings), as the TPL demonstrated a negative result for 125 of the 148 subjects whose clinical diagnosis was negative for amniotic fluid leakage. The overall agreement between the TPL readings of the clinician and that of the subject was 97.40%. The TPL is a reliable test to determine the presence of amniotic fluid leakage.

The AL-SENSE Test is Reliable for Detection of Second Trimester Amniotic Fluid

“…test, microscopic evaluation for ferning and ultrasound determination of intra-uterine amniotic volume [2]. These results were confirmed by another study [3] comparing the panty-liner test to speculum examination for detection of ruptured membranes; it found 98% sensitivity and 65% specificity.…”

“…The color change was stable for 12 hours, the time determined in advance as the completion of the study. So far, the validity of the AL-Sense panty liner has been proven in clinical studies in diagnosing premature rupture of membranes in the third trimester [1][2][3]. However, the effectiveness of this test had not been tested in second trimester pregnancies.…”

“…In previous third trimester clinical studies [1,2], the AL-SENSE panty-liner test was documented as a sensitive tool for diagnosing premature rupture of the membranes (PROM) and differentiating amniotic fluid leaks from urinary incontinence. One study showed 100% negative and 87.1% positive predictive values, with a sensitivity of 100% and specificity of 75%.…”

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

“…These were reported to offer some reassurance to clinicians of intact membranes. 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).…”

Gonadotropina coriónica en flujo vaginal para el diagnóstico de rotura prematura de membranas

“…Sin embargo, en los casos donde no existe RPM, los métodos tradicionales se han asociado con tasas de falsos positivos y falsos negativos de 17,4% y 9,4%, respectivamente (4). Los resultados falsos positivos de la prueba de nitrazina se han asociado con cervicitis, vaginitis, contaminación vaginal por semen, orina alcalina y sangre.…”