Diagnostic method for determining the susceptibility to delivery and reagent kit for use thereof

Abstract

The invention relates to a diagnostic method for detecting susceptibility to delivery, and to a test kit for this purpose. A low, but higher than baseline level concentration of Insulin-like Growth Factor Binding Protein 1 (IGFBP-1), which is due to leakage from decidual cells, is detected by an immunological assay in a vaginal secretion sample.

1 . A method for identifying a patient with intact foetal membranes possessing risk factors indicative of preterm labor comprising 
 a) detecting a level of IGFBP-1 in an essentially blood-free vaginal or cervical secretion sample,    b) comparing said level of IGFBP-1 to a high level of 100 μg/l and a low level of less than 1.0 μg/l and    c) identifying a level of IGFBP-1 that is less than 100 μg/l and equal to or greater than 1 μg/l,    wherein said level of less than 100 μg/l and equal to or greater than 1 μg/l indicates that said patient has intact foetal membranes and possesses risk factors indicative of preterm labor.    
     
     
         2 . The method according to  claim 1 , wherein the level of IGFBP-1 is determined with at least one specific IGFBP-1 binding substance.  
     
     
         3 . The method according to  claim 2 , wherein said level of IGFBP-1 is determined by a quantitative, semiquantitative or qualitative immunological assay.  
     
     
         4 . The method according to  claim 1  or  3 , wherein said at least one specific IGFBP-1 binding substance is an antibody.  
     
     
         5 . The method according to  claim 4 , wherein said antibody is a monoclonal antibody.  
     
     
         6 . The method according to  claim 1  wherein said secretion sample is obtained from the cervix.  
     
     
         7 . A method for assessing the maturity of the cervix and predicting the time of delivery in patients with intact foetal membranes and a post-term pregnancy comprising 
 a) detecting a level of IGFBP-1 in an essentially blood-free vaginal or cervical secretion sample,    b) comparing said level of IGFBP-1 to a high level of 100 μg/l and a low level of less than 1.0 μg/l and    c) identifying a level of IGFBP-1 that is less than 100 μg/l and equal to or greater than 1 μg/l,    wherein said level of less than 100 μg/l and equal to or greater than 1 μg/l indicates intact foetal membranes, maturation of the cervix and impending delivery.    
     
     
         8 . The method according to  claim 7 , wherein the level of IGFBP-1 is determined with at least one specific IGFBP-1 binding substance.  
     
     
         9 . The method according to  claim 8 , wherein said level of IGFBP-1 is determined by a quantitative, semiquantitative or qualitative immunological assay.  
     
     
         10 . The method according to  claim 7  or  9 , wherein said at least one specific IGFBP-1 binding substance is an antibody.  
     
     
         11 . The method according to  claim 10 , wherein said antibody is a monoclonal antibody.  
     
     
         12 . The method according to  claim 1  wherein said secretion sample is obtained from the cervix.  
     
     
         13 . A method for reducing the risk of preterm labor in a patient with intact foetal membranes comprising 
 a) detecting a level of IGFBP-1 in an essentially blood-free vaginal or cervical secretion sample,    b) comparing said level of IGFBP-1 to a high level of 100 μg/l and a low level of less than 1.0 μg/l,    c) identifying a level of IGFBP-1 that is less than 100 μg/l and equal to or greater than 1 μg/l, and    d) prescribing life style changes or medication    wherein said level of less than 100 μg/l and equal to or greater than 1 μg/l indicates that said patient has intact foetal membranes.    
     
     
         14 . The method according to  claim 13 , wherein the level of IGFBP-1 is determined with at least one specific IGFBP-1 binding substance.  
     
     
         15 . The method according to  claim 14 , wherein said level of IGFBP-1 is determined by a quantitative, semiquantitative or qualitative immunological assay.  
     
     
         16 . The method according to  claim 13  or  15 , wherein said at least one specific IGFBP-1 binding substance is an antibody.  
     
     
         17 . The method according to  claim 16 , wherein said antibody is a monoclonal antibody.  
     
     
         18 . The method according to  claim 13  wherein said secretion sample is obtained from the cervix.  
     
     
         19 . A method for assessing the time for induction of delivery in post-term pregnancy patients with intact foetal membranes comprising 
 a) detecting a level of IGFBP-1 in an essentially blood-free vaginal or cervical secretion sample,    b) comparing said level of IGFBP-1 to a high level of 100 μg/l and a low level of less than 1.0 μg/l,    c) identifying a level of IGFBP-1 that is less than 100 μg/l and equal to or greater than 1 μg/l, and    d) initiating induction of delivery    wherein said level of less than 100 μg/l and equal to or greater than 1 μg/l indicates intact foetal membranes.    
     
     
         20 . The method according to  claim 19 , wherein the level of IGFBP-1 is determined with at least one specific IGFBP-1 binding substance.  
     
     
         21 . The method according to  claim 20 , wherein said level of IGFBP-1 is determined by a quantitative, semiquantitative or qualitative immunological assay.  
     
     
         22 . The method according to  claim 19  or  21 , wherein said at least one specific IGFBP-1 binding substance is an antibody.  
     
     
         23 . The method according to  claim 22 , wherein said antibody is a monoclonal antibody.  
     
     
         24 . The method according to  claim 19  wherein said secretion sample is obtained from the cervix.