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Starting soon Observational

Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment

NCT07629271 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-10
Last updated
2026-09-02

Condition(s) studied

Neonatal Acidemia and Hypoxia

Study summary

This study aims to improve understanding of how fetuses respond to oxygen deprivation during labor by re-evaluating cardiotocography (CTG) recordings using a physiology-based interpretation approach and comparing these findings with umbilical cord blood gas measurements at birth, including eucapnic pH assessment.

The study will include term pregnancies and combines retrospective data analysis with prospective enrollment. Researchers will investigate whether physiology-based CTG interpretation can better identify signs of fetal compromise and whether eucapnic pH may improve the distinction between respiratory and metabolic acidosis. Findings may contribute to improving fetal monitoring strategies and the assessment of newborn condition at birth.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Singleton pregnancies * Term neonates (gestational age =or\> 37 weeks) * Availability of clinical data, such as * CTG tracing within 90 minutes before delivery * Umbilical cord blood gas analysis (arterial sample) * Signed informed consent (only for the prospective arm) Exclusion Criteria: * Major fetal anomalies * Incomplete or missing CTG or blood gas data * Elective cesarean sections without labor

Primary outcome measure(s)

  • Detection of fetal decompensation using physiology-based CTG interpretation — From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)
    proportion of cases in which physiology-based CTG interpretation identified features of fetal decompensation not evident in conventional interpretation

Trial sites (1)

FacilityCityRegionStatus
UOC di Ostetricia e Patologia Ostetrica Rome Lazio
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07629271 on ClinicalTrials.gov ↗ ← All trials in Italy