Clinical trial Recruiting at 1 site Observational Ages 0 Hours to 1 Hour

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 typeObservational
Ages0 Hours to 1 Hour
SexAll
Enrollment220 (estimated)
SponsorOslo University Hospital
Academic / other
Locations1 site (Oslo)
StatusRecruiting
StartedNovember 14, 2022
Main results expectedNovember 13, 2030
Study endsDecember 31, 2035
Registry record updatedMarch 18, 2025
Trial IDNCT06186973 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.