Pregnancy Related Clinical Trial
— FANTEOfficial title:
Recording and Study of Probable Fetal Electrocardiographic Signals From Maternal Electrocardiogram in Correlation With Fetal Autonomic Nervous sysTem Development.
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.
Status | Recruiting |
Enrollment | 186 |
Est. completion date | December 28, 2025 |
Est. primary completion date | September 28, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Singleton pregnancy from 23 to 40 weeks of gestation. Exclusion Criteria: - Consent withdrawal - Multiple pregnancy - Singleton pregnancy below 23 weeks or above 40 weeks of gestation - Contractions and signs of labor |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Pisana | Pisa |
Lead Sponsor | Collaborator |
---|---|
University of Pisa | Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Maternal Assesment | Occurrence of obesity, gestacional diabetes, habits such as smoking, alcohol, drug use, medical therapies, reports of maternal pathologies. | Between 23 and 37week of pregnancy (Recruitment visit). | |
Secondary | Obstetric Complications and mode of Delivery | Occurrence of gestational hypertension, pre-eclampsia, intrauterine growth restriction, premature rupture of membranes, preterm labour.
Mode of delivery (spontaneous, cesarean section, operative), neonatal weight and Apgar. |
Recruitment visit; Recording visit; Day of the delivery, in average 16 weeks after recruitment (post-partum visit). |
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