Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04256083
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2020-02-03
Brief Title:
Metabolomic and Proteomic Profiles of Amniotic Fluid Embolism
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Assessment of Metabolomic and Proteomic Phenotyping Associated With Amniotic Fluid Embolism
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMNIOPROFIL
Brief Summary:
Amniotic fluid embolism is a serious complication of the peri-partum period that is associated with high maternal mortality rate ranging from 20 to 40
The pathophysiology of amniotic fluid embolism remains poorly known at this time
The definition and diagnosis of amniotic fluid embolism is only clinical based on different scores the most used of which is the score proposed by the United Kingdom Obstetric Surveillance System UKOSS This score supports the diagnosis of amniotic fluid embolism in the event of acute maternal collapse associated with one or more of the following features cardiac rhythm problems acute fetal compromise respiratory distress maternal hemorrhage coagulopathy convulsions premonitory symptoms restlessness numbness tingling agitation etc seizure in the absence of any other clear cause Amniotic fluid embolism is a differential diagnosis of maternal collapse
Determining specific biological markers for this disease would be very useful in order to be able to affirm the diagnosis and refute other diagnostic hypotheses with certainty The detection of amniotic cells in the blood or bronchoalveolar lavage fluid seems to be of little help The assay of plasma tryptase does not confirm the diagnosis of amniotic embolism but is useful for ruling out the diagnosis of anaphylactic shock The dosage of the complement lacks sensitivity and specificity to be useful in the diagnosis of amniotic fluid embolism The maternal plasma assay of IGFBP-1 Insulin Growth Factor Binding Protein type 1 has been proposed for the biological diagnosis of amniotic embolism IGFBP-1 is present in high concentration in amniotic fluid while its concentration is low in maternal plasma High levels of IGFBP-1 in maternal blood would therefore make it possible to establish the diagnosis of amniotic fluid embolism with excellent sensitivity and specificity according to previous data collected from 25 patients However no study has confirmed this result to date Other markers have also been suggested zinc-coproporphyrin in particular but to date no specific marker for this disease has been formally identified
Metabolic phenotyping consists in the identification of subtle and coordinated metabolic variations associated with various pathophysiological stimuli Different analytical methods such as nuclear magnetic resonance allow the simultaneous quantification of a large number of metabolites Statistical analyses of these spectra thus lead to the discrimination between samples and the identification of a metabolic phenotype corresponding to the effect under study This approach allows the extraction of candidate biomarkers and the recovery of perturbed metabolic networks driving to the generation of biochemical hypotheses pathophysiological mechanisms diagnostic tests therapeutic targets It is thus possible to obtain biochemical characterizations of human biological samples also called metabolic profile or signature which can be compared in order to identify distinctive elements of certain pathophysiological states establishing a metabolic phenotype of the pathological state studied This analysis can be supplemented by a study of the proteome proteomics in order to identify one or more biological markers associated with a disease
The aim of this study is to determine the metabolic and proteomic phenotyping in three groups of women women for whom the diagnosis of amniotic fluid embolism was retained according to the UKOSS clinical criteria Group AFE women admitted for prophylactic elective cesarean section Group Control 1 women presenting acute collapse or shock in the peri- partum for which the diagnosis of amniotic fluid embolism has been excluded severe hemorrhage SEPSIS pulmonary embolism for example Group Control 2
The pathophysiology of amniotic fluid embolism remains poorly known at this time
The definition and diagnosis of amniotic fluid embolism is only clinical based on different scores the most used of which is the score proposed by the United Kingdom Obstetric Surveillance System UKOSS This score supports the diagnosis of amniotic fluid embolism in the event of acute maternal collapse associated with one or more of the following features cardiac rhythm problems acute fetal compromise respiratory distress maternal hemorrhage coagulopathy convulsions premonitory symptoms restlessness numbness tingling agitation etc seizure in the absence of any other clear cause Amniotic fluid embolism is a differential diagnosis of maternal collapse
Determining specific biological markers for this disease would be very useful in order to be able to affirm the diagnosis and refute other diagnostic hypotheses with certainty The detection of amniotic cells in the blood or bronchoalveolar lavage fluid seems to be of little help The assay of plasma tryptase does not confirm the diagnosis of amniotic embolism but is useful for ruling out the diagnosis of anaphylactic shock The dosage of the complement lacks sensitivity and specificity to be useful in the diagnosis of amniotic fluid embolism The maternal plasma assay of IGFBP-1 Insulin Growth Factor Binding Protein type 1 has been proposed for the biological diagnosis of amniotic embolism IGFBP-1 is present in high concentration in amniotic fluid while its concentration is low in maternal plasma High levels of IGFBP-1 in maternal blood would therefore make it possible to establish the diagnosis of amniotic fluid embolism with excellent sensitivity and specificity according to previous data collected from 25 patients However no study has confirmed this result to date Other markers have also been suggested zinc-coproporphyrin in particular but to date no specific marker for this disease has been formally identified
Metabolic phenotyping consists in the identification of subtle and coordinated metabolic variations associated with various pathophysiological stimuli Different analytical methods such as nuclear magnetic resonance allow the simultaneous quantification of a large number of metabolites Statistical analyses of these spectra thus lead to the discrimination between samples and the identification of a metabolic phenotype corresponding to the effect under study This approach allows the extraction of candidate biomarkers and the recovery of perturbed metabolic networks driving to the generation of biochemical hypotheses pathophysiological mechanisms diagnostic tests therapeutic targets It is thus possible to obtain biochemical characterizations of human biological samples also called metabolic profile or signature which can be compared in order to identify distinctive elements of certain pathophysiological states establishing a metabolic phenotype of the pathological state studied This analysis can be supplemented by a study of the proteome proteomics in order to identify one or more biological markers associated with a disease
The aim of this study is to determine the metabolic and proteomic phenotyping in three groups of women women for whom the diagnosis of amniotic fluid embolism was retained according to the UKOSS clinical criteria Group AFE women admitted for prophylactic elective cesarean section Group Control 1 women presenting acute collapse or shock in the peri- partum for which the diagnosis of amniotic fluid embolism has been excluded severe hemorrhage SEPSIS pulmonary embolism for example Group Control 2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None