[Comparison of two bedside tests performed on cervicovaginal fluid to diagnose premature rupture of membranes]

Abstract

Objective: To compare the performance of two rapid tests for the diagnosis of premature rupture of membranes (PROM) based on the detection of the insulin-like growth factor-binding protein-1 (IGFBP-1) and placental α-microglobulin-1 (PAMG-1) in cervicovaginal secretions.

Methods: A case-control prospective study. Pregnant women between 24 and 41(6/7) weeks' of gestation, consulting for profuse amniotic fluid loss (group 1) or for other reasons without any rupture of membrane (group 2) were included in the study. Successively, AmniSure(®) test (PAMG-1) without speculum, and then Actim™Prom test (IGFBP-1) during speculum examination were performed during the same visit.

Results: Eighty subjects (40 in each group) were included between 25(1/7) to 41(1/7) weeks of gestation. AmniSure(®) diagnostic test demonstrated a sensitivity and specificity of 95 % (82.4-99.4) and 94.8 % (79.3-98) respectively and a positive and negative predictive value of 95 % (84.7-100) and 94.8 % (87.9-100) respectively. Actim™Prom diagnostic test demonstrated a sensitivity and specificity of 97.5 % (85.7-100) and 97.4 % (82.4-99.4) respectively and a positive and negative predictive value of 97.5 % (88.5-100) and 97.4 % (92.5-100) respectively.

Conclusion: Both tests have similar performance to diagnose premature rupture of membranes.