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 determining the susceptibility to delivery and the maturity of the cervix when foetal membranes of a pregnant woman are intact, wherein the method comprises detecting a level of insulin-like growth factor binding protein 1 (IGFBP-1) in a vaginal or cervical secretion sample with an antibody that recognizes IGFBP-1. 
     
     
         2 . The method according to  claim 1 , wherein said antibody is a monoclonal antibody. 
     
     
         3 . The method according to  claim 1 , wherein said level of IGFBP-1 is determined by a quantitative, semiquantitative or qualitative immunological assay. 
     
     
         4 . The method according to  claim 1 , wherein said secretion sample is obtained from the cervix. 
     
     
         5 . The method according to  claim 1 , wherein the method comprises detecting an IGFBP-1 level that is equal to or greater than a normal baseline level of pregnancy. 
     
     
         6 . The method according to  claim 1 , wherein said determined level of IGFBP-1 is above about 1 μg/l. 
     
     
         7 . The method according to  claim 1 , wherein the method comprises providing medical advice designed to prevent preterm delivery. 
     
     
         8 . The method according to  claim 1  for identifying a pregnant woman possessing risk factors indicative of preterm delivery, wherein the method comprises detecting a level of IGFBP-1 being equal to or greater than said normal baseline level of pregnancy indicating that said pregnant woman possesses risk factors indicative of preterm delivery, said risk factors of said pregnant woman being increased as compared to pregnant women with an IGFBP-1 level below said normal baseline level of pregnancy. 
     
     
         9 . The method according to  claim 1  for assessing a time for induction of labor, wherein the method comprises initiating induction of labor for a pregnant woman where said sample, despite intact foetal membranes, has an IGFBP-1 level that is equal to or greater than a normal baseline level of pregnancy, wherein said level of IGFBP-1 being equal to or greater than said normal baseline level of pregnancy indicates maturation of the cervix of said pregnant woman and impending delivery. 
     
     
         10 . The method according to  claim 9 , wherein said time of induction is assessed in pregnant women with a post-term pregnancy. 
     
     
         11 . The method according to  claim 9 , wherein said time of induction is assessed in pregnant women with a risk of pre-term delivery. 
     
     
         12 . The method according to  claim 1 , wherein the method comprises detecting that the foetal membranes are intact by examination. 
     
     
         13 . The method according to  claim 1 , wherein the method comprises detecting that the foetal membranes are intact by a diagnostic method detecting a level of IGFBP-1 in a vaginal or cervical secretion sample from a pregnant woman with an antibody that recognizes IGFBP-1 and wherein said sample has an IGFBP-1 level that is below a high IGFBP-1 level caused by the presence of amniotic fluid resulting from rupture of a foetal membrane. 
     
     
         14 . The method according to  claim 13 , wherein said high IGFBP-1 level is above about 100 μg/l.