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Fetal Assessment of the Myocardium and Evaluation of the Neonate
Sponsor: Oslo University Hospital
Summary
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, and umbilical cord blood gases and neonatal outcomes (as specified in FAME-n) will be investigated.
Key Details
Gender
All
Age Range
0 Hours - 1 Hour
Study Type
OBSERVATIONAL
Enrollment
220
Start Date
2022-11-14
Completion Date
2035-12-31
Last Updated
2025-03-18
Healthy Volunteers
Not specified
Interventions
Monitoring with Neobeat heart rate meter
At the designated time for cord clamping as per clinical indication, a 10 cm segment of the umbilical cord will be double-clamped and 5 ml of preferably arterial blood will be obtained. In infants brought to the resuscitation table, six ECG electrodes will be placed on the skin and cardiac output will be measured with a hemodynamic monitor (PhysioFlow®) for at least 10 min, or until the end of resuscitation/stabilization.
Maternal arterial blood gases
Arterial blood gases will be drawn from a radial artery line and analyzed at the end of a contraction at pre-specified time points during labor.
Amniotic fluid lactate
Amniotic fluid will be collected (2mL) and analyzed at pre-specified time points after rupture of the membranes.
Locations (1)
Oslo University Hospital
Oslo, Norway