The Diagnosis of ROM: A Comparison of the AmniSure® ROM Test with the results of indigo carmine intra-amniotic injection

Objective: To evaluate the potential of the AmniSure® ROM Test to diagnose rupture of membranes by comparing its performance with that of indigo carmine intra-amniotic injection in patients suspected of ROM. Study Design: A prospective study was conducted. Women presenting to the labor and delivery unit with clinical suspicion of ROM (24 to 42 weeks of gestation) were invited to participate in the study. The study was approved by the IRB and all patients provided written informed consent. Patients were evaluated by sterile speculum examination (pooling, nitrazine and ferning), ultrasound and the AmniSure® ROM Te…