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

NCT07629271 | Not Yet Recruiting

• 1 other identifier: 27264
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Acidemia and Hypoxia

Keywords

cardiotocography; eucapnic pH; neonatal hypoxia; labor and delivery

Outcome Measures

Primary Outcomes (1)

• Detection of fetal decompensation using physiology-based CTG interpretation

  proportion of cases in which physiology-based CTG interpretation identified features of fetal decompensation not evident in conventional interpretation

  From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)

Study Arms (1)

Pregnant women who deliver neonates presenting hypoxia

Participants will include term singleton pregnancies undergoing labor and delivery with available intrapartum cardiotocography (CTG) recordings and umbilical cord arterial blood gas analysis. Two cohorts will be included: a retrospective cohort of eligible deliveries occurring between 2018 and 2025 and a prospective cohort of consecutively enrolled term pregnancies from 2026 onward. This is an observational study with no experimental intervention, treatment allocation, or modification of standard clinical care. The study involves collection of clinical data and re-evaluation of CTG tracings using a physiology-based interpretation framework combined with assessment of cord blood gas parameters, including eucapnic pH.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females are eligible because the study population consists of pregnant women undergoing labor and delivery. The study evaluates intrapartum cardiotocography findings, labor characteristics, and neonatal outcomes associated with pregnancy and childbirth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women with term singleton pregnancies undergoing labor and delivery at a tertiary referral center. The study includes both retrospectively identified deliveries and prospectively enrolled pregnancies with available intrapartum cardiotocography (CTG) recordings and umbilical cord arterial blood gas analysis.

You may qualify if:

• 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)

You may not qualify if:

• Major fetal anomalies
• Incomplete or missing CTG or blood gas data
• Elective cesarean sections without labor

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC di Ostetricia e Patologia Ostetrica

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Hypoxia; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tullio Ghi, Chief

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  STUDY DIRECTOR

Central Study Contacts

Silvio Tartaglia, MD, PhD

CONTACT

+390630157024; silvio.tartaglia@policlinicogemelli.it

Alessandro Petrecca, MD

CONTACT

+390630157024; alessandro.petrecca@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)