Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330987
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-02-29
Brief Title:
Fetal Autonomic Nervous sysTem Evaluation
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
Official Title:
Recording and Study of Probable Fetal Electrocardiographic Signals From Maternal Electrocardiogram in Correlation With Fetal Autonomic Nervous sysTem Development
Status:
RECRUITING
Status Verified Date:
2024-03
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:
FANTE
Brief Summary:
The autonomic nervous system ANS is involved in cardiovascular metabolic and cognitive processes so its study in the fetus can provide relevant functional diagnostic and prognostic information In particular the study of the fetal ANS allows us to understand the degree of nervous maturation reached by the fetus and any developmental disorders that could have an impact on the cardiovascular characteristics of the fetus
The goal of this open-label non-randomized prospective observational study is to study the fetal ANS in pregnant women between 23 and 40 weeks of gestation
The objetives are
To Evaluate Fetal Autonomic Nervous System FANTE through the analysis of maternal electrocardiogram ECG and others clinical parameters usually used in pregnancy monitoring
To identify any variations in the fetal ECG in the event of developmental or pathological maternal andor fetal pregnancy
Participants will be recruited during ultrasound visits information sessions and hospitalizations after signing informed consent
The goal of this open-label non-randomized prospective observational study is to study the fetal ANS in pregnant women between 23 and 40 weeks of gestation
The objetives are
To Evaluate Fetal Autonomic Nervous System FANTE through the analysis of maternal electrocardiogram ECG and others clinical parameters usually used in pregnancy monitoring
To identify any variations in the fetal ECG in the event of developmental or pathological maternal andor fetal pregnancy
Participants will be recruited during ultrasound visits information sessions and hospitalizations after signing informed consent
Detailed Description:
The Autonomic Nervous System ANS is the main regulator of the bodys homeostasis It consists of two branches that work in balance the sympathetic nervous system SNS and the parasympathetic nervous system PNS The SNS is responsible for the fight-or-flight response while the PNS is responsible for the recovery response The coordination of their actions is vital for the bodys proper functioning The two branches of the ANS develop asynchronously during fetal development particularly from the vagus nerve X pair of cranial nerves within the PNS However its activity is severely limited by late myelination and the tone of the SNP undergoes a first increase at around 25-32 weeks and a second increase at 37 weeks In contrast SNS maturation continues steadily throughout pregnancy It has been recognized that imbalances in the development of the SNS may underlie intrauterine death problems adapting to extrauterine life pediatric morbidity and increased risk of sudden infant death syndrome SIDS Altered ANS functioning has been linked to developmental pathologies in childhood including autism spectrum disorders and other neuropsychiatric conditions as well as adult cardiovascular and metabolic diseases The causes of altered autonomic development are diverse including factors related to pregnancy and pre-existing maternal pathologies The primary causes are premature birth abnormalities in placenta formation and development intrauterine growth restriction IUGR maternal diabetes hypothyroidism substance abuse and maternal mental illness
Given this evaluating the extent of ASN development may have significant implications not only in the obstetric and neonatal setting but also in the long term Sympathetic and parasympathetic tone indicators can be studied by examining Heart Rate Variability HRV on an electrocardiogram ECG Certain parameters can be detected in HRV that indicate different facets of autonomic tone mainly the activity of the SNS LF band the PNS HF band and the sympathetic-vagal balance LFHF Obtaining these parameters however requires the analysis of an electrocardiographic trace which is not easy to acquire in intrauterine life
The collaboration between the University of Pisa and the Institute of Clinical Physiology of the National Research Council of Italy IFC-CNR has led to the development of the FANTE method FANTE Fetal Autonomic Nervous Evaluation enables the analysis of electrocardiographic traces acquired by placing electrodes on the maternal abdomen The traces are interpreted using an algorithm developed by researchers at IFC-CNR enabling extraction of HRV data with the same level of accuracy as fetal magnetocardiography In sum this method that allows accurate extraction of fetal ECGs from multichannel maternal abdominal signals It represents a non-invasive and affordable option which are fundamental characteristics for screening tools
The assessment of FANTE has the potential to serve as a basis for risk stratification in populations affected by maternal or fetal disease This tool may prove valuable for early diagnosis allowing planning for more rigorous prenatal monitoring and comprehensive postnatal diagnosis
Women with a singleton pregnancy attending or admitted to the Department of Obstetrics and Gynecology will be recruited between the 24th and 37th week of pregnancy After signing the informed consent they will be enrolled into the study
At recruitment visit
Maternal anthropometric evaluation will be performed age body mass index BMI blood pressure smokingalcoholdrug habits medical therapies or pathologies
Fetal well-being evaluation will be carried out by reviewing the reports of laboratory and ultrasound screening tests
The FANTE recordings will be performed using a 10-lead ECG placed on the maternal abdomen
at FANTE periodic visit
FANTE registrations will be performed weekly
Standard maternal anthropometric assessments will be conducted as part of the periodic evaluations
At delivery
Mode of delivery and any complications will be assessed
Within 48 hours of birth anthropometric assessment of the infant according to clinical practice weight abdominal and head circumference
Given this evaluating the extent of ASN development may have significant implications not only in the obstetric and neonatal setting but also in the long term Sympathetic and parasympathetic tone indicators can be studied by examining Heart Rate Variability HRV on an electrocardiogram ECG Certain parameters can be detected in HRV that indicate different facets of autonomic tone mainly the activity of the SNS LF band the PNS HF band and the sympathetic-vagal balance LFHF Obtaining these parameters however requires the analysis of an electrocardiographic trace which is not easy to acquire in intrauterine life
The collaboration between the University of Pisa and the Institute of Clinical Physiology of the National Research Council of Italy IFC-CNR has led to the development of the FANTE method FANTE Fetal Autonomic Nervous Evaluation enables the analysis of electrocardiographic traces acquired by placing electrodes on the maternal abdomen The traces are interpreted using an algorithm developed by researchers at IFC-CNR enabling extraction of HRV data with the same level of accuracy as fetal magnetocardiography In sum this method that allows accurate extraction of fetal ECGs from multichannel maternal abdominal signals It represents a non-invasive and affordable option which are fundamental characteristics for screening tools
The assessment of FANTE has the potential to serve as a basis for risk stratification in populations affected by maternal or fetal disease This tool may prove valuable for early diagnosis allowing planning for more rigorous prenatal monitoring and comprehensive postnatal diagnosis
Women with a singleton pregnancy attending or admitted to the Department of Obstetrics and Gynecology will be recruited between the 24th and 37th week of pregnancy After signing the informed consent they will be enrolled into the study
At recruitment visit
Maternal anthropometric evaluation will be performed age body mass index BMI blood pressure smokingalcoholdrug habits medical therapies or pathologies
Fetal well-being evaluation will be carried out by reviewing the reports of laboratory and ultrasound screening tests
The FANTE recordings will be performed using a 10-lead ECG placed on the maternal abdomen
at FANTE periodic visit
FANTE registrations will be performed weekly
Standard maternal anthropometric assessments will be conducted as part of the periodic evaluations
At delivery
Mode of delivery and any complications will be assessed
Within 48 hours of birth anthropometric assessment of the infant according to clinical practice weight abdominal and head circumference
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