Methods for Determining The Risk of Prenatal Complications

Abstract

The disclosure relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual has for developing pre-eclampsia based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers. The disclosure also relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual is carrying a fetus having a chromosomal abnormality based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers.

1 . A method for determining the risk of pre-eclampsia in a pregnant individual, comprising:
 determining the amount of one or more biochemical markers selected from placental growth factor (PlGF) and pregnancy-associated plasma protein A (PAPP-A) in one or more blood samples from the individual;   determining the blood pressure of the individual; and   determining the risk of pre-eclampsia using the amount of each of the selected one or more biochemical markers and the blood pressure of the individual,   wherein determining the risk comprises determining a likelihood ratio for blood pressure and calculating a final risk based on the individual's prior risk of developing pre-eclampsia and a set of likelihood ratios based on the amounts of the one or more biochemical markers and the blood pressure.   
     
     
         2 . The method of  claim 1 , further comprising determining uterine artery pulsatility index (PI) of the individual; and determining the risk of pre-eclampsia using the amount of each of the selected one or more biochemical markers and the blood pressure of the individual, and the PI. 
     
     
         3 . The method of  claim 1 , wherein the pre-eclampsia is early pre-eclampsia. 
     
     
         4 . The method of  claim 1 , wherein the one or more biochemical markers is PlGF. 
     
     
         5 . The method of  claim 1 , wherein the one or more biochemical markers is PAPP-A. 
     
     
         6 . The method of  claim 1 , wherein the one or more biochemical markers are PlGF and PAPP-A. 
     
     
         7 . The method of  claim 1 , further comprising determining the amount of placental protein 13 (PP13) and determining the risk of pre-eclampsia using the amount of each of the selected one or more biochemical markers, the blood pressure of the individual and amount of PP13. 
     
     
         8 . The method of  claim 1 , wherein the blood pressure is mean arterial blood pressure. 
     
     
         9 - 10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein multivariate Gaussian analysis is performed to determine the likelihood ratios. 
     
     
         12 . The method of  claim 1 , further comprising using likelihood ratios for one or more maternal history parameters selected from race, smoking, parity, BMI, hypertension, previous pre-eclampsia, and mother/sister with previous pre-eclampsia. 
     
     
         13 . The method of  claim 1 , wherein the method for determining the risk of pre-eclampsia in an individual has a detection rate of at least about 65% and a false positive rate of about 10%. 
     
     
         14 . The method of  claim 1 , wherein the method for determining the risk of pre-eclampsia in an individual has a detection rate of at least about 75% and a false positive rate of about 10%. 
     
     
         15 . The method of  claim 1 , wherein the method for determining the risk of pre-eclampsia in an individual has a detection rate of at least about 90% and a false positive rate of about 10%. 
     
     
         16 . The method of  claim 1 , wherein the method for determining the risk of pre-eclampsia in an individual has a detection rate of at least about 95% and a false positive rate of about 10%. 
     
     
         17 . (canceled) 
     
     
         18 . An apparatus for determining the risk of pre-eclampsia in a pregnant individual, comprising:
 a data input means for inputting the amounts of one or more biochemical markers selected from placental growth factor (PlGF) and pregnancy-associated plasma protein A (PAPP-A) in one or more blood samples from the individual, and the blood pressure of the individual; and   a calculation means for determining the risk of developing pre-eclampsia using the input amounts of the biochemical markers and the blood pressure,   wherein determining the risk comprises determining a likelihood ratio for blood pressure and calculating a final risk based on the individual's prior risk of developing pre-eclampsia and a set of likelihood ratios based on the amounts of the one or more biochemical markers and the blood pressure.   
     
     
         19 . (canceled)