Comparative evaluation of test systems for determining premature rupture of membranes

Abstract

Introduction. Preterm premature rupture of the membranes (PPROM) is one of the most common pregnancy complications. PPROM as а cause of infectious complications poses the greatest danger with increasing duration of period without amniotic fluid (i.e., watchful waiting) in full-term pregnancy.Aim. Comparative evaluation of  test systems for  the diagnosis of  premature rupture of  the membranes  (PROM) based on the determination of the pH of the vaginal contents, the detection of placental alpha macroglobulin-1 (PAMG) or insulin-like growth factor-binding protein 1 (IGFBP-1).Materials and methods. The study included 52 patients at 22–41 weeks of gestation in whom, according to the clinical examination, it is impossible to exclude/confirm PROM. All women were examined for the detection of PROM using test systems: nitrazine pH test, immunochromatographic test for the detection of IGFBP-1 or PAMG-1. The sensitivity, specificity, accuracy, predictive value of positive and negative results were calculated.Results. As a result of the study, premature rupture of the membranes was confirmed in 25 cases, and this diagnosis was excluded in 27 cases. In three observations, additional observation and examination were required due to the questionable interpretation of  the result due to a  test error. Sensitivity and specificity were 64.0  and 66.7% for  the nitrazine test, 95.8  and 92.3% for IGFBP-1, and 95.8 and 96.3% for PAMG-1.Conclusion. The nitrazine test has low sensitivity and specificity, therefore, for the diagnosis of PROM, test systems based on the determination of PAMG-1 and IGFBP-1 should be used, which improves the quality of diagnosis, reduces the risk of complications and ensures the timely start of a set of measures appropriate to the clinical situation. A negative test result avoids unnecessary hospitalization and unnecessary interventions, which is important both from a medical and economic point of view.