Fetal Autonomic Nervous sysTem Evaluation

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

Interventions

DEVICE

electrocardiograph

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.

Sponsors & Collaborators

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

  collaborator OTHER_GOV

• University of Pisa

  lead OTHER

Principal Investigators

• Paolo Mannella, MD. PhD. · Department of Clinical and Experimental Medicine. University of Pisa

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-13

Primary Completion

2025-09-28

Completion

2025-12-28

Countries

• Italy

Study Locations