Fetal Autonomic Nervous sysTem Evaluation

RecruitingOBSERVATIONAL
Enrollment

186

Participants

Timeline

Start Date

August 13, 2019

Primary Completion Date

September 28, 2025

Study Completion Date

December 28, 2025

Conditions
Pregnancy RelatedPregnancy DiseasePregnancy ComplicationsPre-EclampsiaGestational DiabetesECG Electrode Site ReactionFetal Growth RetardationFetal 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.

Trial Locations (1)

56126

RECRUITING

Azienda Ospedaliera Universitaria Pisana, Pisa

All Listed Sponsors
collaborator

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

OTHER_GOV

lead

University of Pisa

OTHER