Improving heart assessment in fetuses and newborns
Fetal Assessment of the Myocardium and Evaluation of the Neonate
This study is testing new ways to check the heart health of unborn babies and newborns to help prevent serious problems during delivery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 0 Hours to 1 Hour |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06186973 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance perinatal care by developing new methods for assessing fetal and neonatal heart health. It focuses on identifying high-risk deliveries to reduce the incidence of perinatal asphyxia and related complications. The study employs innovative technology to monitor cardiovascular transitions in a larger population of fetuses and newborns than previously possible. Additionally, it includes an obstetric arm that investigates the relationship between maternal oxygenation and neonatal outcomes during labor.
Who should consider this trial
Good fit: Ideal candidates include pregnant women in labor and their newborn infants who are at risk of mild to moderate perinatal asphyxia.
Not a fit: Patients with severe perinatal asphyxia requiring therapeutic hypothermia or those with major congenital anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification and management of at-risk newborns, potentially reducing morbidity and mortality associated with perinatal asphyxia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving neonatal outcomes through enhanced monitoring techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Åsa Waldum, PhD — Oslo University Hospital
- Study coordinator: Anne Lee Solevåg, MD, PhD
- Email: a.l.solevag@medisin.uio.no
- Phone: +4741469314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.