Method of predicting risk of preterm birth

A risk, SE-CAD technology, applied in the direction of biochemical equipment and methods, biological testing, measuring devices, etc., can solve the problem of no reliable and clear markers of premature birth

Inactive Publication Date: 2012-11-21
THE TRUSTEES OF THE UNIV OF PENNSYLVANIA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Although some progress has been made so far, there are still no reliable and definitive markers for preterm birth

Method used

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  • Method of predicting risk of preterm birth
  • Method of predicting risk of preterm birth
  • Method of predicting risk of preterm birth

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Example 1. Premature delivery due to intrauterine infection results in decreased expression of E-cadherin in cervical tissue

[0065] In this example, a mouse model of intrauterine infection was used 16-18 , inject lipopolysaccharide (a component of the cell wall of Gram-negative bacteria, LPS) into its uterine horn. The female animals gave birth between 8-20 hours, most of them gave birth within 12 hours, and there were no deaths. 14，15，19-21 Intrauterine inflammation is associated with premature cervical ripening that occurs before clinical labor begins. 16 The cervix of dams exposed to intrauterine LPS had fewer collagen fibers, a less dense matrix, and increased mucin compared to controls. 16 Cervical ripening appears to be an initial event in the pathogenesis of inflammation-induced PTB.

[0066] Using the mouse model of intrauterine infection described above, cervical tissue was harvested from dams exposed to LPS or saline at 2, 4 and 6 hours. Using QPCR, it w...

Embodiment 2

[0067] Example 2. Full-term delivery is also associated with decreased E-cadherin mRNA expression, as this pathway in cervical remodeling is hypothesized to be common to all deliveries

[0068] Using QPCR, E-cadherin mRNA expression was measured in non-pregnant cervix, across gestation in time-pregnant mice, and postpartum. For this mouse strain, parturition occurred on a predictable time course as E19. "E#" refers to the date of the embryo used to determine the gestation period of the mouse, where the first 24 hours of gestation was recorded as E0. Thus, 12 hours earlier than E19 (E18.5) represents just before term labor. E-cadherin mRNA levels were significantly different between groups (P=0.001, one-way ANOVA). E-cadherin mRNA levels increased at E15 (preterm; second trimester) compared to non-pregnant levels (P=0.007, SNK). E-cadherin mRNA level decreased 4.3 times at E18.5 compared with E15 (P=<0.001, SNK), which supports the expression of E-cadherin also occurs in ful...

Embodiment 3

[0069] Example 3. Increased SE-Cadherin (SE-CAD) in Maternal Serum Before Parturition in an Inflammation-Induced Preterm Mouse Model

[0070] Using the mouse model of Example 1, SE-CAD was measured in maternal serum at 2, 4 and 6 hours after intrauterine infusion of LPS or saline. SE-CAD was measured using a commercially available ELISA (Human E-CAD Monoclonal Antibody ELISA Kit from R&D Biosystems). as figure 1 As noted, SE-CAD levels were significantly different between LPS- and saline-exposed dams (P=<0.001, one-way ANOVA). SE-CAD levels continued to rise for 6 hours (before the onset of clinical labor in this model). These data support that serum SE-CAD is a marker of E-cadherin breakdown, particularly at the cervical site, thereby enabling the systematic detection of cervical remodeling.

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Abstract

A method for diagnosing, or differentially diagnosing, an increased risk of pre-term birth (PTB) involves detecting or measuring increased expression of a biomarker Soluble E-cadherin (SE-CAD) in a biological sample from a mammalian subject, particularly in the urine, cervicovaginal fluid or blood. An increased level of expression of SE-CAD above the level of expression in the same sample of a healthy mammalian subject is an indication of a diagnosis of increased risk of PTB. Such diagnosis may further involve identify other clinical symptoms of PTB or PTL. Additionally the method may use additional biomarkers, such as fetal fibronectin.

Description

Background of the invention [0001] Preterm birth (PTB) is the leading cause of neonatal death and an important factor in neonatal morbidity. Approximately 12% of all live births in the United States are premature, ie, before 37 weeks of gestation. PTB incidence is not declining and, in fact, has shown an upward trend. PTB is costly, not only for immediate neonatal care, but also for the long-term care required for ongoing morbidity due to premature birth 1 . Care of premature infants consumes a significant portion of health care costs devoted to children. Recent data suggest that PTB causes more long-term sequelae than previously recognized, including significant neurobehavioral abnormalities by the time these children reach school age. Effective prevention or treatment of PTB can significantly reduce neonatal mortality and morbidity, as well as healthcare costs. Treatment targeting pregnant women at highest risk of PTB is urgently needed. However, these types of interve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68C12Q1/68
CPCC12Q1/6883C12Q1/6809C12Q2600/158G01N2333/705G01N2800/368G01N33/689G01N2333/78
Inventor M・A・埃洛韦兹
Owner THE TRUSTEES OF THE UNIV OF PENNSYLVANIA
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