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Fetal Assessment of the Myocardium and Evaluation of the Neonate

Recruitingn/aAges 0 Hours - 1 HourAllOslo University Hospital
NCT06186973 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

FAME-n aims to improve perinatal care by introducing new approaches to fetal and neonatal heart assessment. Better identification of high-risk deliveries requiring intervention will reduce perinatal asphyxia-related illness and death. Neonatal hemodynamics may be improved by early detection of instability of the heart and circulation. Innovative use of technology enables characterization of normal and abnormal cardiovascular transition in a significantly larger number of fetuses and newborn infants than what was previously possible. The methods used may have broad generalizability and applicability in perinatal, neonatal and pediatric medicine. In September 2023, the project was expanded with an obstetric arm called Epidural analgesia: Fetal Oxygenation and Maternal Oxygenation (Epi-FOMO). In Epi-FOMO, the relationship between maternal breathing and arterial blood gases during labour, a

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📋 Eligibility rules (as published)
Inclusion Criteria: Women admitted for labor and newborn infants will be included after written consent from both parents (if applicable). The final inclusion criterion is that CTG with STAN is used for fetal surveillance at clinician's discretion. Exclusion Criteria: Perinatal asphyxia fulfilling the criteria for therapeutic hypothermia, major malformations and stillbirth, known chromosomal anomalies or congenital heart defects other than a patent ductus arteriosus.
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What it tests

  • Monitoring with Neobeat heart rate meter
  • Maternal arterial blood gases
  • Amniotic fluid lactate
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Where

1 site
Oslo University Hospital
Oslo, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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