Evaluating the fetal autonomic nervous system during pregnancy
Recording and Study of Probable Fetal Electrocardiographic Signals From Maternal Electrocardiogram in Correlation With Fetal Autonomic Nervous sysTem Development.
University of Pisa · NCT06330987
This study is testing how the baby's nervous system develops during pregnancy to see if there are any signs of health issues, and it's for pregnant women between 23 and 40 weeks along.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 186 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pisa (other) |
| Locations | 1 site (Pisa) |
| Trial ID | NCT06330987 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the fetal autonomic nervous system (ANS) in pregnant women between 23 and 40 weeks of gestation. By analyzing maternal electrocardiograms and other clinical parameters, the study seeks to identify variations in fetal ECG that may indicate developmental or pathological issues. The research focuses on understanding the maturation of the fetal ANS and its implications for cardiovascular health and potential developmental disorders. Participants will be recruited during routine ultrasound visits and information sessions.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with singleton pregnancies between 23 and 40 weeks of gestation.
Not a fit: Patients with multiple pregnancies or those who are outside the specified gestational age range will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into fetal development and help identify risks for complications in pregnancy and beyond.
How similar studies have performed: While the study of fetal autonomic nervous system is a relatively novel approach, similar studies have shown promise in understanding fetal development and associated risks.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pisa
- Azienda Ospedaliera Universitaria Pisana — Pisa, Italy (RECRUITING)
Study contacts
- Principal investigator: Paolo Mannella, MD. PhD. — Department of Clinical and Experimental Medicine. University of Pisa
- Study coordinator: Paolo Mannella, MD. PhD.
- Email: paolo.mannella@unipi.it
- Phone: 0039.050.993523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Related, Pregnancy Disease, Pregnancy Complications, Pre-Eclampsia, Gestational Diabetes, ECG Electrode Site Reaction, Fetal Growth Retardation, Fetal Complications