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

1. september 2026 oppdatert av: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Neonatal Outcomes After Acute Hypoxia: Re-evaluating Cardiotocography Traces Using Fetal Physiology-Based Interpretation 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

1000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Italia
    • Lazio
      • Rome, Lazio, Italia, 00168
        • UOC di Ostetricia e Patologia Ostetrica
        • Ta kontakt med:
        • Underetterforsker:
          • Silvio Tartaglia, MD, PhD
        • Underetterforsker:
          • Alessandro Petrecca, MD
        • Underetterforsker:
          • Beatrice Valentini, MD
        • Underetterforsker:
          • Roberta Rullo, MD
        • Underetterforsker:
          • Alice Dal Miglio, MD
        • Underetterforsker:
          • Federico Quintiliani, MD
        • Underetterforsker:
          • Marta Vicidomini, MD
        • Underetterforsker:
          • Tullio Ghi, MD, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Detection of fetal decompensation using physiology-based CTG interpretation
Tidsramme: 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
From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Etterforskere

  • Studieleder: Tullio Ghi, Chief, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 27264

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared because the study involves retrospective and prospective collection of sensitive clinical and perinatal data, and data sharing may not be compatible with institutional policies, participant privacy protection, and applicable data protection regulations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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