The clinical significance of a positive Amnisure test™ in women with term labor with intact membranes

Abstract

Objective. The Amnisure ROM test is approved for the diagnosis of rupture of membranes (ROM). Yet, a fraction of patients with a positive test have intact membranes by sterile speculum examination. The objective of this study was to determine the clinical significance of this finding. Methods. The study population consisted of four groups of nulliparous women at term: (1) not in labor without clinical evidence of ROM (n=125); (2) in labor without clinical ROM with a negative Amnisure test (n=56); (3) in labor without clinical ROM with a positive Amnisure test (n=25); and (4) in labor with clinical ROM (n=30). The Amnisure test was performed in cases without clinical ROM (Groups 1, 2 and 3). Results. (1) The Amnisure test was positive more frequently in women in labor with intact membranes than in patients not in labor at term without ROM (30.9% (25/81 women) vs. 4.8% (6/125 women); p0.001); (2) patients in labor without clinical ROM with a positive Amnisure test had a significantly shorter admission-to-delivery interval than those in labor without clinical ROM with a negative Amnisure test (p0.05). Conclusion. (1) A positive Amnisure test is present in about one-third nulliparous women at term presenting in labor with intact membranes; (2) patients with a positive Amnisure test had a shorter admission-to-delivery interval than those with a negative test.