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Infection-related preterm birth diagnostic method

A testing method, a small technology, applied in the direction of disease diagnosis, biochemical equipment and methods, microbe determination/inspection, etc., can solve the problem of unidentification

Inactive Publication Date: 2020-09-11
UNIV OF WESTERN AUSTRALIA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] To date, it has not been possible to identify women at risk of sPTB based on their uroplasma status, despite the fact that uroplasma is the most common organism in infected preterm labor and is readily treatable
This is the main shortcoming of current sPTB prediction methods

Method used

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  • Infection-related preterm birth diagnostic method
  • Infection-related preterm birth diagnostic method
  • Infection-related preterm birth diagnostic method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0210] The UPCAN study: Vaginal colonization of Mycoplasma uroplasma, Mycoplasma, and Candida species in low-risk, asymptomatic pregnant women A prospective study in its association with spontaneous preterm birth.

[0211] subjects

[0212] The study consisted of 206 low-risk pregnant women recruited from the King Edward Memorial Hospital (KEMH) in Perth, Western Australia. Fifteen cases withdrew from the study or lost follow-up, leaving 191 cases for analysis. The study was approved by the Human Research Ethics Committee of the Western Australian Department of Health, Women and Newborn Health Service (2056 / EW).

[0213] Inclusion and Exclusion Criteria

[0214] Women with singleton pregnancies were eligible if they were aged 18-40, could speak and read English, and were pregnant during the first or second trimester.

[0215] Women were excluded from the study if they were considered to be at high risk for PTB (one or more previous PTBs) and / or other pregnancy complic...

Embodiment 2

[0296] Predict1000 study: Microbial markers for preventing preterm birth

[0297] Two studies were conducted: a large cohort study of women with prenatal care and a smaller substudy of novel microbial biomarkers.

[0298] group study

[0299] The study will expand the data on the prevalence of U. parvum, U. urealyticum, and M. hominis in the vagina during pregnancy and will improve the prevalence of key BV-related organisms within this subgroup by defining to expand further.

[0300] In addition, the study will record vaginal fluid pH and sialidase levels during pregnancy and be appropriately powered to detect associations between all these factors and primary and secondary outcomes. Both nulliparous and multiparous women who came to KEMH's antenatal clinic before 20 weeks of gestation within a 12-month period were invited to participate. Recruitment was enriched by preferentially selecting women with a prior history of PTB. Women will not be eligible if they are takin...

Embodiment 3

[0342] Clinical Trials of the "Screen and Treat" Program

[0343] Test design

[0344] Prospective, open-label, randomized clinical trial of a novel maternal microbiome 'screen and treat' program for the prevention of preterm birth.

[0345] Second-trimester identification of unselected women with singleton pregnancies and a vaginal microbial profile associated with increased risk of PTB, followed by targeted antimicrobial therapy, would reduce the rate of spontaneous preterm delivery by at least 30%.

[0346] Inclusion and Exclusion Criteria

[0347] Women will be eligible for inclusion if they have a singleton pregnancy ≥16 years of age with ultrasound-confirmed GA.

[0348] Women will not be eligible for inclusion if they have multiple gestation, symptomatic vaginal infection, vaginal bleeding, ruptured membranes, active contractions, antimicrobial therapy ≤ 14 days prior to enrollment.

[0349] Primary and Secondary Endpoints

[0350] The primary endpoint was ≥30...

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Abstract

A method to determine if a pregnant woman is at risk of infection-associated spontaneous pre- term birth (sPTB), the method comprising the steps of: b) testing a sample of vaginal fluid for the presence of the following bacteria: iv) Ureaplasma parvum genotype SV3 and / or Ureaplasma parvum genotype SV6; v) Gardnerella vaginalis; and vi) Lactobacillus iners wherein the presence of the bacteria indicates that the subject is at risk of sPTB.

Description

technical field [0001] The present invention relates to methods and kits for diagnosing a pregnancy at risk of premature birth (PTB) due to ascending intrauterine infection. Background technique [0002] Despite decades of research and significant advances in the understanding of etiology, PTB remains a major obstetric care problem of national and global significance. PTB is the only leading cause of death and disability in children up to five years of age in developed countries and is the leading single cause of perinatal mortality and morbidity; approximately 15 million babies are born prematurely worldwide each year. Although many premature babies go on to lead normal, healthy lives, a significant proportion do not survive or are permanently disabled; the impact on individuals, families, and society is enormous, as are the medical costs associated with perinatal care and lifelong disability. [0003] About 20% of cases of spontaneous PTB (sPTB) are due to intrauterine in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/04C12Q1/06C12Q1/689C12Q1/6851G01N33/569
CPCC12Q1/689C12Q1/04C12Q2600/118G01N2800/368G01N2333/335G01N2333/30G01N2333/40C12Q1/6883C12Q2600/158
Inventor J.基兰M.S.佩恩
Owner UNIV OF WESTERN AUSTRALIA
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