Fetal Autonomic Nervous sysTem Evaluation

NCT06330987 | Recruiting

• 1 other identifier: 15110_MANNELLA
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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 and/or fetal pregnancy. Participants will be recruited during ultrasound visits, information sessions, and hospitalizations after signing informed consent.

Conditions

Pregnancy Related; Pregnancy Disease; Pregnancy Complications; Pre-Eclampsia; Gestational Diabetes; ECG Electrode Site Reaction; Fetal Growth Retardation; Fetal Complications

Keywords

FANTE

Outcome Measures

Primary Outcomes (1)

• Fetal Autonomic Nervous sysTem Evaluation (FANTE)

  The outcome measure assessed is heart rate variability (HRV), which is analyzed using the FANTE algorithm. HRV serves as an indicator of various facets of autonomic tone, including sympathetic (low frequency band, LF 0.04 - 0.15 Hz), parasympathetic (high frequency band, HF 0.15 - 0.4 Hz), and sympathetic-parasympathetic balance (LF/HF ratio) activity. Data are collected weekly, with each session lasting 10 minutes.

  Between 23 and 40 weeks of pregnancy (Recording visit).

Secondary Outcomes (2)

• Maternal Assesment

  Between 23 and 37week of pregnancy (Recruitment visit).

• Obstetric Complications and mode of Delivery

  Recruitment visit; Recording visit; Day of the delivery, in average 16 weeks after recruitment (post-partum visit).

Interventions

electrocardiograph DEVICE

Ten standard derivation electrodes were used to acquired FANTE registrations. The peripheral electrodes (Left (L), Right (R) and Foot (F)) were placed on the maternal abdomen in a triangle around the navel (orange) with lower apex, while the precordial ones (C1, C2, C3, C4, C5, C6) were put on an external circle. The Neutral electrode was on the right side of the patient abdomen. The software was configured so that the system acquired and wrote on disk 8 signals (2 bipolar and 6 referenced to the centroid of the three L, R and F leads) at 1000 sps with a resolution of 0.763uV. This high resolution is needed to resolve the very small voltage changes related to fetal cardiac activity.

Also known as: Touch ECG HD+ (Cardioline S.p.A.)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with a singleton pregnancy attending or admitted to the Obstetrics and Gynecology Unit of the Santa Chiara Hospital, AOUP.

You may qualify if:

• Singleton pregnancy from 23 to 40 weeks of gestation.

You may not qualify if:

• Consent withdrawal
• Multiple pregnancy
• Singleton pregnancy below 23 weeks or above 40 weeks of gestation
• Contractions and signs of labor

Sponsors & Collaborators

• University of Pisa: lead
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Pre-Eclampsia; Diabetes, Gestational; Fetal Growth Retardation

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Paolo Mannella, MD. PhD.

  Department of Clinical and Experimental Medicine. University of Pisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Mannella, MD. PhD.

CONTACT

0039.050.993523; paolo.mannella@unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 26, 2024
• Study Start: August 13, 2019
• Primary Completion: September 28, 2025
• Study Completion: December 28, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)