Amniotic Fluid EmbolismAMNIOPROFILNCT04256083
Metabolomic and Proteomic Profiles of Amniotic Fluid Embolism
An observational study of Amniotic Fluid Embolism, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Amniotic Fluid Embolism
- What is being tested?
- Biological analysis
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Jun 2021to 25 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will focus on women with clinical criteria for amniotic embolism for whom the samples were sent to the fetal-maternal biology laboratory of Hospices Civils de Lyon (HCL), women with peri-partum collapse for which the diagnosis of amniotic embolism is excluded, and women admitted to term for a scheduled cesarean.
Who may be able to join
- Group AFE
- adult women
- presenting the diagnostic criteria for amniotic embolism according to the UKOSS initiative,
- having no known notable medical history (class of the American Society of Anesthesiologists 1)
- and whose samples were taken within the first 6 hours of collapse and were sent to the fetal-maternal biology laboratory of the Hospices Civils de Lyon (HCL).
- Group Control 1
Show all 14Show fewer
- term adult women
- admitted for scheduled caesarean, term (> 38 weeks), without pathology or associated medical history (class of the American Society of Anesthesiologists 1),
- biological sample planned before the cesarean section (search for irregular agglutinins).
- Group Control 2:
- term adult women (> 38 weeks)
- presenting a collapse (systolic blood pressure <80 mmHg twice and for> 5 minutes) or acute peri-partum shock, for which the diagnosis of amniotic embolism is not retained,
- no known notable medical history (class of the American Society of Anesthesiologists 1),
- sampling taken within the first 6 hours of the shock or collapse.
Who cannot join
- Refusal to participate
- birth as part of an intrauterine fetal death or a therapeutic termination of pregnancy
- preeclampsia, eclampsia
- Gestational Diabetes
- any known endocrine pathology (diabetes, dysthyroidism, adrenal insufficiency, pituitary and hypothalamic diseases).
- history of autoimmune disease
- hemoglobin rate <7 g / dl at the time of sampling (Control group 1 and 2)
- major protected (guardianship, curatorship) or placed under judicial protection
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service Anesthésie réanimation - Centre Hospitalier Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, 69500
Service d'anesthésie réanimation Hôpital de la Croix Rousse
Lyon, 69004
Service d'anesthésie réanimation Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310
Service Anesthésie Réanimation CHU de Hautepierre, Strasbourg
Strasbourg, 67000
About this study
Official title: Assessment of Metabolomic and Proteomic Phenotyping Associated With Amniotic Fluid Embolism
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.
Read more
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)
- Conditions
- Amniotic Fluid Embolism
- Being tested
- Biological analysis
- Medical subject headings
- Embolism, Amniotic Fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological analysisBiological
Two blood samples of 4 ml each (total: 8 ml) for IGFBP1 assay and metabolic phenotyping and proteomic analysis.
| Study group | Role | What they receive |
|---|---|---|
| AFE (amniotic fluid embolism) | Women for whom the diagnosis of amniotic fluid embolism was retained according to the UKOSS criteria. Receives: Biological: Biological analysis | |
| Control 1 | Women admitted for prophylactic elective cesarean section. Receives: Biological: Biological analysis | |
| Control 2 | Women with acute collapse in the peripartum period (with systolic blood pressure <80 mmHg twice and for> 5 minutes or acute peri-partum shock, for which the diagnosis of amniotic embolism has been ruled out). Receives: Biological: Biological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic phenotyping of amniotic fluid embolism
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.
Blood sample taken within the first 6 hours of collapse (Groups AFE and Control 2) and prior patient arrival in the operating room (Group Control1)
Measured: 6 hours
Proteomic analysis of amniotic fluid embolism
Study of the proteome (proteomics), in order to identify one or more biological markers associated with a disease.
Blood sample taken within the first 6 hours of collapse (Groups AFE and Control 2) and prior patient arrival in the operating room (Group Control1)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start24 Jun 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic Fluid EmbolismStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256083
- Sponsor's protocol ID
- 69HCL19_0840
- Acronym
- AMNIOPROFIL
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2020
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metabolomic and Proteomic Phenotyping Associated With Amniotic Fluid Embolism
- ClinicalTrials.gov ID
- NCT04256083
- Acronym / sponsor ID
- AMNIOPROFIL / 69HCL19_0840
- Conditions
- Amniotic Fluid Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AFE (amniotic fluid embolism) | – | Biological: Biological analysisWomen for whom the diagnosis of amniotic fluid embolism was retained according to the UKOSS criteria. |
| Control 1 | – | Biological: Biological analysisWomen admitted for prophylactic elective cesarean section. |
| Control 2 | – | Biological: Biological analysisWomen with acute collapse in the peripartum period (with systolic blood pressure <80 mmHg twice and for> 5 minutes or acute peri-partum shock, for which the diagnosis of amniotic embolism has been ruled out). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will focus on women with clinical criteria for amniotic embolism for whom the samples were sent to the fetal-maternal biology laboratory of Hospices Civils de Lyon (HCL), women with peri-partum collapse for which the diagnosis of amniotic embolism is excluded, and women admitted to term for a scheduled cesarean.
Key inclusion criteria (14 listed)
- Group AFE
- Group Control 1
- Group Control 2:
Key exclusion criteria (8 listed)
- Refusal to participate
- birth as part of an intrauterine fetal death or a therapeutic termination of pregnancy
- preeclampsia, eclampsia
- Gestational Diabetes
- any known endocrine pathology (diabetes, dysthyroidism, adrenal insufficiency, pituitary and hypothalamic diseases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological analysisTwo blood samples of 4 ml each (total: 8 ml) for IGFBP1 assay and metabolic phenotyping and proteomic analysis. | Biological | AFE (amniotic fluid embolism), Control 1, Control 2 |
Primary outcome
Metabolic phenotyping of amniotic fluid embolism
Time frame: 6 hours
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. Blood sample taken within the first 6 hours of collapse (Groups AFE and Control 2) and prior patient arrival in the operating room (Group Control1)
Proteomic analysis of amniotic fluid embolism
Time frame: 6 hours
Study of the proteome (proteomics), in order to identify one or more biological markers associated with a disease. Blood sample taken within the first 6 hours of collapse (Groups AFE and Control 2) and prior patient arrival in the operating room (Group Control1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Amniotic Fluid Embolism
RecruitingObservational study
The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)
Amniotic Fluid Embolism
Not yet recruitingObservational study
Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section
Amniotic Fluid Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amniotic Fluid Embolism, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic phenotyping of amniotic fluid embolism (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.