Improving heart assessment in fetuses and newborns
Official title: Fetal Assessment of the Myocardium and Evaluation of the Neonate
Run by Oslo University Hospital · NCT06186973 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Hours to 1 Hour |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Status | Recruiting |
| Started | November 14, 2022 |
| Main results expected | November 13, 2030 |
| Study ends | December 31, 2035 |
| Registry record updated | March 18, 2025 |
| Trial ID | NCT06186973 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women in labor and their newborn infants who are at risk of mild to moderate perinatal asphyxia.
✕Probably not a fit
Patients with severe perinatal asphyxia requiring therapeutic hypothermia or those with major congenital anomalies will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies have shown promise in improving neonatal outcomes through enhanced monitoring techniques.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.