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Screening for gestational disorders

a gestational disorder and screening technology, applied in the direction of instruments, material analysis, biological material analysis, etc., can solve the problems of increased risk of pih, significant maternal and fetal morbidity and mortality, and increased cesarean section ra

Inactive Publication Date: 2008-09-04
THE GENERAL HOSPITAL CORP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009]The invention is based on the discovery that sex hormone binding globulin (SHBG) and / or placental growth factor (P1GF) can be used as early indicators for the risk of developing any of the pregnancy complications preeclampsia, gestational diabetes, and gestational hypertension. The assays for SHBG and P1GF are simple and inexpensive, can be performed during the first trimester as early as 5 weeks after conception, and do not require any preparation on the part of the woman (for example, the tests can be done under fasting or non-fasting conditions). Thus, the invention provides methods for utilizing insulin resistance biomarkers, such as SHBG and cytokines such as interleukin-6 (IL-6), and angiogenic biomarkers, such as P1GF and soluble fms-like tyrosine kinase 1 (sFlt1), as indicators of the risk for developing various pregnancy complications.
[0021]In addition to their use to identify women who are at risk, the new methods can be used as a routine screen or “pre-screen” for all pregnant women to identify those women who are not at risk for gestational complications, thus avoiding the need for additional testing later during pregnancy.

Problems solved by technology

These disorders can occur in the third-trimester of pregnancy and are associated with significant maternal and fetal morbidity and mortality.
In addition, GDM is associated with increased cesarean section rates and increased risk of PIH.
Prophylactic strategies to prevent PIH, including calcium supplementation and aspirin therapy, have been mostly unsuccessful.
One reason these trials have failed is that the absence of screening tests limits the ability to administer the therapeutic interventions early enough to modify pregnancy outcome.
For example, diagnosing PE by the appearance of edema and proteinuria alone is unreliable as edema is common in normal pregnancies and measurable proteinuria usually occurs only after hypertension is manifested.
Therefore, such a test lacks specificity and fails to detect GDM or PIH prior to manifestation of the disease in the third trimester of pregnancy.

Method used

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Examples

Experimental program
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Effect test

example 1

SHBG and P1GF Assays

[0137]Study Population and Data Acquisition

[0138]A prospective nested case-control study of patients who had enrolled in the Massachusetts General Hospital Obstetrical Maternal Study (MOMS) was performed. In brief, the MOMS cohort was established in 1998 for the prospective study of early gestational risk factors for adverse outcomes that occur later in pregnancy. For this study, consecutive women with singleton gestations between Jun. 1, 2001 and May 1, 2003 who enrolled in the MOMS cohort at approximately 12 weeks of gestation, and who delivered after 20 weeks were eligible for inclusion. All subjects provided written informed consent.

[0139]The electronic medical record, which is the medical record used by the clinical staff, provides clinical and demographic data that prospectively details the events of pregnancy through the early postpartum period. Specific information obtained from the electronic medical record included age, race, height, weight, blood press...

example 2

Cytokine Assays

[0150]The present invention demonstrates that the alteration of a single cytokine or growth factor can be used to identify subjects having, or predisposed to having, preeclampsia, GDM or GH. Urine, plasma, and serum samples were tested for cytokine levels using a cytokine array (Zyomyx®). The array permits the quantitative analysis of 30 cytokines and chemokines, including IL-1α, IL-3, IL-6, IL-10, IL-12 (p70), TNF-A, MCP-1, CD95 (sFas), IP-10, GM-CSF, IL-1β, IL-4, IL-7, IL-12 (p40), IL-13, TNF-β, MCP-3, MIG, CD23, GCSF, IL-2, IL-5, IL-8, IL-12 (p40 / p70), IL-15, Eotaxin, TRAIL, sICAM-1, TGF-β and IFN-γ, using a sample volume of approximately 40 μl of complex biological fluids, such as serum or urine. The data quality is comparable to standards established by ELISA assays. A spike / recovery analysis in urine was carried out and recovery of cytokines in urine (r=0.92) was determined. All subjects had normal renal function, thus it was unlikely that urea interfered with t...

example 3

Growth Factor Assays

[0155]In conjunction with cytokine levels, the present studies provide information regarding the levels of growth factors in urine and blood samples. Serum and urine samples from 16 weeks of gestation in 15 subjects (5 who developed GDM, 5 PE, and 5 controls) were tested with commercially available ELISA kits for exemplary growth factors sFlt-1, free-VEGF, and free-P1GF (R&D Systems). These ELISA kits have inter-assay and intra-assay CV's of <10%. All assays were performed in duplicate, and the averages are reported in FIGS. 5 and 6. Free-VEGF levels were undetectable, consistent with low VEGF levels generally detected at term.

[0156]The data derived from serum samples shown in FIG. 5 indicates that, compared to control women, women who develop GDM have low free P1GF and slightly elevated sFlt-1 levels at 16 weeks of gestation. Moreover, women who subsequently develop PE have even lower free P1GF and higher sFlt-1 levels at this same time period. The balance of an...

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Abstract

The invention relates to methods and compositions for identifying 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.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application is a divisional of U.S. patent application Ser. No. 10 / 947,791, filed Sep. 23, 2004, which claims the benefit of U.S. Provisional Patent Application No. 60 / 505,707, filed on Sep. 23, 2003. The contents of the foregoing are incorporated herein by reference in their entirety.STATEMENT AS TO FEDERALLY SPONSORED RESEARCH[0002]This invention was made with Government support under HD39223 awarded by the National Institutes of Health. Thus, the Government has certain rights in the invention.TECHNICAL FIELD[0003]This invention relates to screening for gestational disorders, and more particularly to screening for biomarkers present in a biological sample obtained from a pregnant subject that are indicative of a gestational disorder.BACKGROUND[0004]Gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH) complicate 2-3% and 5-10% of all pregnancies, respectively. These disorders can occur in the third-trimester o...

Claims

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Application Information

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IPC IPC(8): G01N33/53G01N33/68
CPCG01N33/689G01N33/6893G01N2800/042G01N2800/321Y10S436/809G01N2800/368G01N2800/52Y10S436/804G01N2800/36
Inventor THADHANI, RAVI I.KARUMANCHI, S. ANANTH
Owner THE GENERAL HOSPITAL CORP
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