ASSAY METHOD TO RULE OUT RUPTURE OF MEMBRANES IN WOMEN AT RISK FOR IMMINENT DELIVERY

摘要

The present invention provides an assay that distinguishes those patients with impending imminent delivery with intact membranes from those in whom the membranes have ruptured. The method comprises obtaining a cervicovaginal secretion sample from a pregnant patient determined to be as at risk for imminent delivery by detection of a biochemical marker for imminent delivery in a cervicovaginal secretion sample from the patient and determining the level of IGFBP-1 in the sample. If the level of IGFBP-1 is elevated, the patient has rupture of membranes. If IGFBP-1 is not present, the patient has intact membranes. In a preferred embodiment, the method comprises obtaining a cervicovaginal secretion sample from a pregnant patient after about week 20 of gestation and determining the level of fetal fibronectin and IGFBP-1 in the sample. The presence of an elevated fibronectin level in the sample indicates an increased risk of imminent delivery. If the level of IGFBP-1 is elevated, the patient had rupture of membranes. If IGFBP-1 is not present, the patient has intact membranes. If IGFBP-1 is not present, the IGFBP-1 assay is preferably repeated. In those patients with an increased level of IGFBP-1, the test indicates that delivery cannot be delayed.