Actively Recruiting
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Led by Oslo University Hospital · Updated on 2025-03-18
220
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
South-Eastern Norway Regional Health Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how to better assess the heart health of fetuses and newborn babies to improve care during and after birth. The study focuses on identifying babies at risk of perinatal asphyxia, a condition caused by lack of oxygen around the time of birth that can lead to illness or brain injury. The study also explores how maternal breathing during labor, especially with epidural pain relief, affects the baby's oxygen levels and health outcomes. The research involves monitoring babies with cardiotocography and ST-segment analysis during labor, comparing those whose mothers receive epidural analgesia to those who do not. Blood samples from the umbilical cord and amniotic fluid will be collected to study oxygen and acid levels. Newborns will have heart monitoring using ECG and cardiac output measurements shortly after birth, especially if they need resuscitation or stabilization. Participants will be monitored from labor through delivery and the first minutes after birth. Researchers will collect data including heart electrical activity, cardiac enzymes, and blood gases, while also observing newborn outcomes. This data will help understand normal and abnormal heart transition from fetus to newborn. The study will continue to gather information until the newborn is at least 10 minutes old, with ongoing analysis of maternal and fetal blood samples during labor.
CONDITIONS
Brief Title
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women admitted for labor and newborn infants up to 1 hour old
- Written consent from both parents (if applicable) obtained
- Use of cardiotocography with ST-segment analysis (STAN) for fetal monitoring as decided by the clinician
You will not qualify if you...
- Perinatal asphyxia severe enough to require therapeutic hypothermia
- Major malformations or stillbirth
- Known chromosomal anomalies
- Congenital heart defects other than patent ductus arteriosus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 hour after birth
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During labor until delivery
Participants undergo fetal monitoring during labor using cardiotocography with ST-segment analysis (STAN) and collection of maternal arterial blood gases and amniotic fluid lactate at specified times.
Monitoring during labor with blood and fluid samples collected at pre-specified times
Duration - From birth until 10 minutes of age
After birth, neonatal ECG and cardiac output are measured for up to 10 minutes. Umbilical cord blood biomarkers are collected at the time of cord clamping.
1 visit (in-person) with continuous monitoring for 10 minutes
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
Research Team
A
Anne Lee Solevåg, MD, PhD
K
Kathrine Samuelsen Hansen, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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