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NCT Number: NCT07629271

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UOC di Ostetricia e Patologia Ostetrica

Rome, Lazio, 00168, Italy

Location contact

Alessandro Petrecca, MD

SUB_INVESTIGATOR

Alice Dal Miglio, MD

SUB_INVESTIGATOR

Beatrice Valentini, MD

SUB_INVESTIGATOR

Concetta Cesare

CONTACT

[email protected]

+390630158531

Federico Quintiliani, MD

SUB_INVESTIGATOR

Marta Vicidomini, MD

SUB_INVESTIGATOR

Roberta Rullo, MD

SUB_INVESTIGATOR

Silvio Tartaglia, MD, PhD

SUB_INVESTIGATOR

Tullio Ghi, MD, PhD

SUB_INVESTIGATOR

About this study

Cardiotocography (CTG) is widely used for intrapartum fetal surveillance; however, traditional pattern-recognition approaches may not always reflect the underlying fetal physiological response to hypoxic stress. Recently, physiology-based CTG interpretation frameworks have been proposed to improve identification of fetal compensation and decompensation mechanisms during labor.

Similarly, conventional interpretation of umbilical cord blood gas analysis may not adequately distinguish respiratory from metabolic components of neonatal acidemia. Eucapnic pH, calculated by correcting for the respiratory component of acid-base imbalance, has been proposed as a tool to better characterize metabolic compromise at birth.

This ambispective observational study aims to re-evaluate CTG tracings obtained during labor using a physiology-based interpretative framework and to integrate these findings with arterial umbilical cord blood gas parameters, including measured pH, base excess, pCO2, and calculated eucapnic pH.

The study includes a retrospective cohort of term singleton deliveries and a prospective cohort of consecutively enrolled term pregnancies undergoing intrapartum CTG monitoring. CTG recordings will undergo blinded re-evaluation by independent reviewers using physiology-based criteria. These findings will be integrated with maternal, intrapartum, and neonatal variables to explore relationships between CTG characteristics, types of hypoxic exposure, acid-base status, and neonatal outcomes.

The study aims to determine whether physiology-based CTG interpretation identifies fetal compromise not recognized using conventional interpretation methods and to evaluate the relationship between CTG findings, eucapnic pH, and neonatal condition at birth. The results may contribute to improving understanding of intrapartum fetal adaptation and refining strategies for fetal surveillance during labor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Detection of fetal decompensation using physiology-based CTG interpretation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Petrecca, MD

CONTACT

[email protected]

+390630157024

Silvio Tartaglia, MD, PhD

CONTACT

[email protected]

+390630157024

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Neonatal Outcomes After Acute Hypoxia: Re-evaluating Cardiotocography Traces Using Fetal Physiology-Based Interpretation and Eucapnic pH Assessment

Acronym: NOAH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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