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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Silvio Tartaglia, MD, PhD
- Numer telefonu: +390630157024
- E-mail: silvio.tartaglia@policlinicogemelli.it
Kopia zapasowa kontaktu do badania
- Nazwa: Alessandro Petrecca, MD
- Numer telefonu: +390630157024
- E-mail: alessandro.petrecca@guest.policlinicogemelli.it
Lokalizacje studiów
-
-
Lazio
-
Rome, Lazio, Włochy, 00168
- UOC di Ostetricia e Patologia Ostetrica
-
Kontakt:
- Concetta Cesare
- Numer telefonu: +390630158531
- E-mail: att@policlinicogemelli.it
-
Pod-śledczy:
- Silvio Tartaglia, MD, PhD
-
Pod-śledczy:
- Alessandro Petrecca, MD
-
Pod-śledczy:
- Beatrice Valentini, MD
-
Pod-śledczy:
- Roberta Rullo, MD
-
Pod-śledczy:
- Alice Dal Miglio, MD
-
Pod-śledczy:
- Federico Quintiliani, MD
-
Pod-śledczy:
- Marta Vicidomini, MD
-
Pod-śledczy:
- Tullio Ghi, MD, PhD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Detection of fetal decompensation using physiology-based CTG interpretation
Ramy czasowe: 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)
|
Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Tullio Ghi, Chief, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 27264
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .