Labor Pain Clinical Trial
— FAME-nOfficial title:
Fetal Assessment of the Myocardium and Evaluation of the Neonate
NCT number | NCT06186973 |
Other study ID # | 28911 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 14, 2022 |
Est. completion date | December 31, 2035 |
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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2035 |
Est. primary completion date | November 13, 2030 |
Accepts healthy volunteers | |
Gender | All |
Age group | 0 Hours to 1 Hour |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | South-Eastern Norway Regional Health Authority |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Maternal arterial blood gases | Oxygen partial pressure (pO2) and carbondioxide partial pressure (pCO2) | Four times during 1st stage of labor, during pushing and after delivery, maximum duration 24 hours of total labor time | |
Other | Amniotic fluid lactate | Analyzed in 2mL amniotic fluid | Four times during 1st stage of labor, and during pushing, maximum duration 24 hours of total labor time | |
Primary | Neonatal ECG | Blindly categorized neonatal ECG | From birth until 10 minutes of age | |
Primary | Cardiac enzymes | Umbilical cord blood cardiac enzymes: Creatine kinase (CK)-MB and troponin T | At the designated time for cord clamping as per clinical indication | |
Primary | Cardiac output | Cardiac output | From birth at least until 10 minutes of age | |
Primary | STAN | Blindly categorized STAN ECG raw data | 10 minutes prior to delivery | |
Secondary | Autonomic function | Umbilical cord blood metanephrines | At the designated time for cord clamping as per clinical indication |
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