PI: Menard, Mary

This is a prospective, multi-center study designed to evaluate the clinical test performance characteristics (sensitivity and specificity) of the Actim PROM test in pregnant women < 34 weeks gestation presenting with signs and/or symptoms of rupture of fetal membranes (ROM). Additionally, this study will evaluate the clinical performance of the Actim PROM test with specimen collected without use of a speculum. This test is intended for the rapid detection of amniotic fluid in vaginal secretions during pregnancy. The results of this study are intended to generate sufficient clinical data to support regulatory filings in the United States.