An Ambispective, Observational Study to Evaluate the Cases of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology-Based Interpretation and Eucapnic pH Assessment (NOAH)
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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Silvio Tartaglia, MD, PhD
- Telefonnummer: +390630157024
- E-mail: silvio.tartaglia@policlinicogemelli.it
Undersøgelse Kontakt Backup
- Navn: Alessandro Petrecca, MD
- Telefonnummer: +390630157024
- E-mail: alessandro.petrecca@guest.policlinicogemelli.it
Studiesteder
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Lazio
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Rome, Lazio, Italien, 00168
- UOC di Ostetricia e Patologia Ostetrica
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Kontakt:
- Concetta Cesare
- Telefonnummer: +390630158531
- E-mail: att@policlinicogemelli.it
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Underforsker:
- Silvio Tartaglia, MD, PhD
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Underforsker:
- Alessandro Petrecca, MD
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Underforsker:
- Beatrice Valentini, MD
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Underforsker:
- Roberta Rullo, MD
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Underforsker:
- Alice Dal Miglio, MD
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Underforsker:
- Federico Quintiliani, MD
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Underforsker:
- Marta Vicidomini, MD
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Underforsker:
- Tullio Ghi, MD, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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)
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proportion of cases in which physiology-based CTG interpretation identified features of fetal decompensation not evident in conventional interpretation
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From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Tullio Ghi, Chief, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 27264
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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