424: AmnioTectTM– Detecting PROM using a specially designed panty liner

Abstract

To determine the performance characteristics of AmnioTectTM to detect premature rupture of membranes (PROM) by distinguishing amniotic fluid from urine, among pregnant women experiencing leaking or perineal moisture. Prospective multicenter observational study comparing self-assessment with blinded investigator assessment using AmnioTect TMin women presenting for PROM evaluation between December 2016 to October 2017. Eligible women were asked to wear and interpret the AmnioTect TMaccording to instructions for use. The same pad was independently evaluated by a blinded health care provider (HCP) and both the patient and HCP assessments were compared to standard clinical PROM evaluation by sterile speculum exam. The presence of amniotic fluid and the diagnosis of PROM was established when pooling was observed along with either positive nitrazine and/or positive ferning test. The primary outcome was to compare patient use of AmnioTectTM to clinical diagnosis and secondarily to compare patient to HCP interpretation. A total of 244 women were recruited, but only 240 were analyzed with complete results. The mean age was 27.7 years (SD: 5.46), with a range 18.2 - 40.9. The mean gestational age at enrollment was 36.7 weeks, with a range of 18.9 - 41.4 weeks. Only 3 patients were < 24 weeks and 16 (6.6%) patients were < 28 weeks. The cohort was racially and educationally diverse. Only 36% of the cohort had > high school education and 58% had either completed or had some high school education. The prevalence of confirmed PROM was 45% (108/240). The patient interpreted AmnioTectTMas positive in 103/108 yielding a sensitivity of 95.4% and a specificity of 96.2% (127/132). The overall concordance between the HCP reading the AmnioTectTMresult and that of the patient was 99.6% (239/240). The PPV: 95.4% (103/108) and the NPV: 96.2 (127/132). The performance characteristics of AmnioTectTMcompare favorably when interpreted by a patient or a HCP. AmnioTectTMserves as a good screening for the outpatient detection of PROM.