Screening for gestational disorders
AssigneesThe General Hospital Corporation, Harvard University
InventorsRavi I. Thadhani, Myles S. Wolf, Tanya Lynn Knickerbocker, Gavin MacBeath
Life of this patent
Estimating the term…
Abstract
The invention relates to methods and compositions for identifying pregnant subjects having, or predisposed to having, gestational diabetes, preeclampsia, and gestational hypertension. The methods are applicable to urine and/or blood samples and can be conducted prior to the third trimester of pregnancy, and as early as the first trimester.
Claims26
A method of determining whether a pregnant human subject has, or is predisposed to having, preeclampsia, the method comprising:
- obtaining a urine sample from the pregnant human subject at between about 16 to 18 or 18 to 24 weeks of gestation;
- measuring levels of at least two specific proteins selected from the group consisting of monocyte chemoattractant protein-1 (MCP-1), soluble TNF receptor I (sTNFR-I), soluble TNF receptor II (sTNFR-II), interleukin (IL)-1α, IL-1β, IL-4, IL-6, and IL-8, in the subject urine sample;
- generating a subject profile comprising at least two values, each value representing a level of one of said specific proteins;
- comparing the subject profile with a reference profile, wherein the reference profile comprises two or more values, each value representing a reference level one of said specific proteins;
- and
- determining whether the pregnant human subject has, or is predisposed to having, preeclampsia based on the comparison of the subject profile with the reference profile.
A method of determining whether a pregnant subject has, or is predisposed to having, preeclampsia, the method comprising:
- obtaining a urine sample from a pregnant subject at between about 16 to 18 or 18 to 24 weeks of gestation;
- measuring levels of two or more specific proteins selected from the group consisting of monocyte chemoattractant protein-1 (MCP-1), soluble TNF receptor I (sTNRF-I), soluble TNF receptor II (sTNFR-II), interleukin (IL)-1α, IL-1β, IL-4, IL-6, and IL-8, in the sample;
- and
- comparing the levels of said specific proteins in the subject urine sample with the levels of said specific proteins in one or more urine samples obtained from (i) a reference subject having preecalampsia;
- (ii) a reference subject having a normal pregnancy;
- or (iii) urine samples from both a reference subject having preeclampsia and a reference subject having a normal pregnancy;
- and
- determining whether the pregnant subject has, or is predisposed to having, preeclampsia based on the comparison of the subject levels of said specific proteins with the one or more reference levels of said specific proteins.
A method of determining whether a pregnant subject has, or is predisposed to having, preeclampsia, the method comprising:
- obtaining a urine sample from a pregnant subject at between about 16 to 18 or 18 to 24 weeks of gestation;
- contacting the sample to an array of two or more immobilized antibodies that recognize specific proteins selected from the group consisting of monocyte chemoattractant protein-1 (MCP-1), soluble TNF receptor I (sTNFR-I), soluble TNF receptor II (sTNFR-II), interleukin (IL)-1α, IL-1β, IL-4, IL-6, and IL-8;
- obtaining a subject profile corresponding to binding of said antibodies in the array that indicates the levels of said specific proteins in the urine sample from the pregnant subject;
- obtaining a reference profile corresponding to binding of said antibodies in the array that indicates the levels of said specific proteins in urine samples from one or more women having a normal pregnancy;
- comparing the subject profile with the reference profile, wherein a difference between the subject profile and the reference profile indicates that the subject has, or is predisposed to having, preeclampsia.
A method of determining whether a pregnant woman subject has, or is predisposed to having, preeclampsia, the method comprising;
- obtaining a urine sample from the pregnant human subject at between about 16 to 18 or 18 to 24 weeks of gestation;
- measuring a level of monocyte chemoattractant protein-1 (MCP-1), IL-1β, IL-6, and IL-8,
- generating a subject profile comprising values representing the levels of MCP-1, IL-1β, IL-6, IL-8;
- comparing the subject profile with a reference profile, wherein the reference profile comprises values representing the levels of MCP-1, IL-1β, IL-6, and IL-8;
- and
- determining whether the pregnant human subject has, or is predisposed to having, preeclampsia based on the comparison of the subject profile with the reference profile.
Dependencies are inferred from the claim text.