title: 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.
authors.affiliation: Western Galilee Hospital, Hatechnion University, Nahariya, Israel.
authors.forename: Jacob
authors.initials: J
authors.lastname: Bornstein
authors.forename: Gonen
authors.initials: G
authors.lastname: Ohel
authors.forename: Yoram
authors.initials: Y
authors.lastname: Sorokin
authors.forename: Kathleen Z
authors.initials: KZ
authors.lastname: Reape
authors.forename: Oleg
authors.initials: O
authors.lastname: Shnaider
authors.forename: Hadar
authors.initials: H
authors.lastname: Kessary-Shoham
authors.forename: Ella
authors.initials: E
authors.lastname: Ophir
mesh_terms: D041342:Absorbent Pads; D000293:Adolescent; D000328:Adult; D000641:Ammonia; D000653:Amniotic Fluid / Q000737:chemistry; D001391:Azo Compounds; D004867:Equipment Design; D005321:Extraembryonic Membranes / Q000502:physiology*; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis; D005865:Gestational Age; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D007743:Labor, Obstetric / Q000502:physiology*; D008875:Middle Aged; D011237:Predictive Value of Tests; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: D001391:Azo Compounds; D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic; C013617:nitrazine yellow; D000641:Ammonia