Non-invasive biomarker to identify subject at risk of preterm delivery

Abstract

Methods for diagnosis to allow prediction of the likelihood of preterm birth based upon the concentration of lipocalin-type prostaglandin D2 synthase (L-PGDS) in cervical vaginal secretions. In addition, specific prostaglandin D2 receptor antagonists may represent novel tocolytic therapeutics.

1 - 5 . (canceled) 
     
     
         6 . A method of detecting increased likelihood of preterm delivery for a pregnant woman, the method comprising:
 detecting the presence of an elevated L-PGDS concentration in a cervicovaginal secretion sample from said pregnant woman;   wherein the presence of elevated levels of L-PGDS relative to a population of women whose pregnancies go to term indicates an increased likelihood of preterm delivery.   
     
     
         7 . The method of  claim 6 , comprising obtaining said cervicovaginal secretion sample from said pregnant woman. 
     
     
         8 . The method of  claim 7 , wherein said sample has been collected by applying an ophthalmic sponge to the cervical os of said pregnant woman. 
     
     
         9 . The method of  claim 8 , wherein said applying is performed at or after 25 weeks of gestation. 
     
     
         10 . The method of  claim 6 , comprising collecting said cervicovaginal secretion sample by application of an ophthalmic sponge to the cervical os of said pregnant woman. 
     
     
         11 . The method of  claim 10 , wherein said applying is performed at or after 25 weeks of gestation. 
     
     
         12 . The method of  claim 6 , comprising detecting in vitro the presence of said elevated L-PGDS concentration in said sample. 
     
     
         13 . The method of  claim 6 , wherein the method further comprises measuring levels of fetal fibronectin in said sample. 
     
     
         14 . The method of  claim 13 , wherein levels of fetal fibronectin are used to predict likelihood of preterm birth in the following two-week period, and levels of L-PGDS are used to predict the likelihood of preterm birth over the gestational period up to parturition 
     
     
         15 . The method of  claim 6 , wherein said population of women whose pregnancies go to term is gestationally age-matched. 
     
     
         16 . A method of delaying preterm delivery in a pregnant woman, the method comprising:
 administering a composition comprising a tocolytic agent to said pregnant woman, wherein said pregnant woman has been identified by the method of  claim 6 .   
     
     
         17 . The method of  claim 16 , wherein said composition comprises a β2 receptor agonist, an NSAID cyclooxygenase inhibitor, a calcium channel blocker, a prostaglandin DP1 or DP2 receptor antagonist, a myosin light chain inhibitor, an oxytocin inhibitor, or magnesium sulfate. 
     
     
         18 . The method of  claim 17 , wherein said composition comprises a β2 receptor agonist, wherein said β2 receptor agonist is at least one of terbutaline, ritodrine, fenoterol, or salbutamol. 
     
     
         19 . The method of  claim 17 , wherein said composition comprises an NSAID cyclooxygenase inhibitor, wherein said NSAID cyclooxygenase inhibitor is at least one of indomethacin or sulindac. 
     
     
         20 . The method of  claim 17 , wherein said composition comprises a calcium channel blocker, wherein said calcium channel blocker is nifedipine. 
     
     
         21 . The method of  claim 17 , wherein said composition comprises magnesium sulfate. 
     
     
         22 . The method of  claim 17 , wherein said composition comprises an oxytocin inhibitor, wherein said inhibitor is atosiban.