METHODS FOR DETERMINING THE RISK OF PRENATAL COMPLICATIONS
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.
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 . The method of claim 1 , wherein determining the risk comprises determining a likelihood ratio for blood pressure.
10 . The method of claim 9 , wherein the determining the risk comprises calculating a final risk based on the individual's prior risk of developing pre-eclampsia and a set of likelihood ratios based the amounts of the one or more biochemical markers and the blood pressure.
11 . The method of claim 10 , wherein multivariate Gaussian analysis is performed to determine the likelihood ratios.
12 . The method of claim 9 , 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 . A medical profile for a pregnant individual, comprising information for determining the risk of pre-eclampsia in the individual, the information comprising the amounts of one or more biochemical markers present in one or more blood samples from the individual, the biochemical markers selected from placental growth factor (PlGF) and pregnancy-associated plasma protein A (PAPP-A); and the blood pressure of the individual, wherein the medical profile is stored on a computer-readable medium.
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.
19 . The apparatus of claim 18 , further comprising
a data input means for inputting one or more parameters selected from age, race, smoking, parity, BMI, hypertension, previous pre-eclampsia, and mother/sister with previous pre-eclampsia, and PI, and a calculation means for determining the risk of developing pre-eclampsia using the input amounts of the biochemical markers, the blood pressure and one or more selected parameter.