An observational study in Pregnancy Related, Pregnancy Disease and Pregnancy Complications, sponsored by University of Pisa. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by University of Pisa · Observational
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Among 17 studies in Pregnancy Complications with a site in Italy — 10 open to participants now, 10 under way, none of them phase 3. Pregnancy Complications · Italy.
Among the 17 studies in Pregnancy Complications with a site in Italy, this one is the 6th largest by planned enrollment of the 12 observational ones that give a count, is one of 2 that started in 2019, is one of 12 observational ones, and was the 13th registered.
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
Browse Pregnancy Complications studies →10 of the 17 studies in Pregnancy Complications with a site in Italy are open now. Recruiting first, the newest first:
Jazz Pharmaceuticals · Sites in Italy, United States, Germany
Women only
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche · Sites in Italy, Austria
Ages 35+ · Women only
Chiesi Farmaceutici S.p.A. · Sites in Italy, United States, Germany and 2 more countries
Women only
Guilherme Sant'Anna, MD · Sites in Italy, Brazil, Canada and 1 more country
Ages 35 wk–42 wk · Healthy volunteers
University of Campania Luigi Vanvitelli · Sites in Italy
Ages 18–35 · Women only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 92 Pregnancy Complications studies recruiting now, 44 (48%) set no upper age limit and 45 (49%) stop at 75 or younger; 22 take children under 18; 35 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
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17 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 186 is below the median of 400 across 198 observational studies indexed under Pregnancy Complications.
Median enrollment 400 across the 5 interventional studies, 168 across the 12 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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2 of 17 have an industry lead sponsor. The 10 most frequent:
University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
University of Pisa has 1 study filed under Pregnancy Complications — fewer than ten, so there is no comparison to draw.
1 of the studies in Pregnancy Complications with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06693817Guilherme Sant'Anna, MDAdvanced Wireless Sensors for Neonatal Care in the Delivery Room | 2027-07-30 |
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Among the 17 studies in Pregnancy Complications with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
Participants will be recruited during ultrasound visits, information sessions, and hospitalizations after signing informed consent.
The Autonomic Nervous System (ANS) is the main regulator of the body's homeostasis. It consists of two branches that work in balance: the sympathetic nervous system (SNS) and the parasympathetic nervous system (PNS). The SNS is responsible for the fight-or-flight response, while the PNS is responsible for the recovery response. The coordination of their actions is vital for the body's proper functioning. The two branches of the ANS develop asynchronously during fetal development, particularly from the vagus nerve (X pair of cranial nerves) within the PNS. However, its activity is severely limited by late myelination, and the tone of the SNP undergoes a first increase at around 25-32 weeks and a second increase at 37 weeks. In contrast, SNS maturation continues steadily throughout pregnancy. It has been recognized that imbalances in the development of the SNS may underlie intrauterine death, problems adapting to extrauterine life pediatric morbidity and increased risk of sudden infant death syndrome (SIDS). Altered ANS functioning has been linked to developmental pathologies in childhood, including autism spectrum disorders and other neuropsychiatric conditions, as well as adult cardiovascular and metabolic diseases. The causes of altered autonomic development are diverse, including factors related to pregnancy and pre-existing maternal pathologies. The primary causes are premature birth, abnormalities in placenta formation and development, intrauterine growth restriction (IUGR), maternal diabetes, hypothyroidism, substance abuse, and maternal mental illness.
Given this, evaluating the extent of ASN development may have significant implications not only in the obstetric and neonatal setting, but also in the long term. Sympathetic and parasympathetic tone indicators can be studied by examining Heart Rate Variability (HRV) on an electrocardiogram (ECG). Certain parameters can be detected in HRV that indicate different facets of autonomic tone, mainly the activity of the SNS (LF band), the PNS (HF band) and the sympathetic-vagal balance (LF/HF). Obtaining these parameters, however, requires the analysis of an electrocardiographic trace, which is not easy to acquire in intrauterine life.
The collaboration between the University of Pisa and the Institute of Clinical Physiology of the National Research Council of Italy (IFC-CNR) has led to the development of the FANTE method. FANTE (Fetal Autonomic Nervous Evaluation) enables the analysis of electrocardiographic traces acquired by placing electrodes on the maternal abdomen. The traces are interpreted using an algorithm developed by researchers at IFC-CNR, enabling extraction of HRV data with the same level of accuracy as fetal magnetocardiography. In sum, this method that allows accurate extraction of fetal ECGs from multichannel maternal abdominal signals. It represents a non-invasive and affordable option, which are fundamental characteristics for screening tools.
The assessment of FANTE has the potential to serve as a basis for risk stratification in populations affected by maternal or fetal disease. This tool may prove valuable for early diagnosis, allowing planning for more rigorous prenatal monitoring and comprehensive postnatal diagnosis.
Women with a singleton pregnancy attending or admitted to the Department of Obstetrics and Gynecology will be recruited between the 24th and 37th week of pregnancy. After signing the informed consent, they will be enrolled into the study.
At recruitment visit:
at FANTE periodic visit:
At delivery:
Women with a singleton pregnancy attending or admitted to the Obstetrics and Gynecology Unit of the Santa Chiara Hospital, AOUP.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.)
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.
Time frame: Between 23 and 40 weeks of pregnancy (Recording visit).
Maternal Assesment
Occurrence of obesity, gestacional diabetes, habits such as smoking, alcohol, drug use, medical therapies, reports of maternal pathologies.
Time frame: Between 23 and 37week of pregnancy (Recruitment visit).
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.
Time frame: Recruitment visit; Recording visit; Day of the delivery, in average 16 weeks after recruitment (post-partum visit).
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2019 (actual). Primary completion is estimated for Sep 2025, 73 months after the start.
Of 113 non-industry observational studies under Pregnancy Complications, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 201. This study's planned 73 months is above that.
Counting every sponsor, half of 121 studies reached it within 60 months; a quarter within 30 and three quarters within 151.
How these figures are worked out, and which studies are left out of them.
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